TAC 2013 PLENARY PAPER
An intensive physiotherapy program improves mobility for trauma patients Sara Calthorpe, BSc (Hons), Elizabeth A. Barber, BPhysio (Hons), Anne E. Holland, PhD, Lara Kimmel, BPhysio, Melissa J. Webb, MHSc, Carol Hodgson, PhD, and Russell L. Gruen, PhD, Melbourne, Victoria, Australia Physiotherapy is integral to modern trauma care. Early physiotherapy and mobility have been shown to improve outcomes in patients with isolated injuries; however, the optimal intensity of physiotherapy in the multitrauma patient population has not yet been examined. The primary aim of this study was to determine whether an intensive physiotherapy program resulted in improved inpatient mobility. METHODS: We conducted a single-center prospective randomized controlled study of 90 consecutive patients admitted to the Alfred Hospital (a Level 1 trauma center) in Australia between October 2011 and June 2012 who could participate in ward-based physiotherapy. Participants were allocated to either usual care (daily physiotherapy treatment, approximately 30 minutes) or intensive physiotherapy (usual care plus two additional 30-minute treatments each day). The primary outcome measure was the modified Iowa Level of Assistance (mILOA) score, collected by a blinded assessor at Days 3 and 5 (or earlier if discharged). Secondary measures included physical readiness for discharge, hospital and rehabilitation length of stay, a patient confidence and satisfaction scale, and quality of life at 6 months. RESULTS: Groups were comparable at baseline. Participants in the intensive physiotherapy group achieved significantly improved mILOA scores on Day 3 (median, 7 points compared with 10 points; p = 0.02) and Day 5 (median, 7.5 points compared with 16 points; p = 0.04) and were more satisfied with their care ( p = 0.01). There was no difference between groups in time to physical readiness, discharge destination, length of stay, or quality-of-life measures. CONCLUSION: Intensive physiotherapy resulted in improved mobility in trauma inpatients. Further studies are required to determine if specific groups benefit more from intensive physiotherapy and if this translates to long-term improvements in outcomes. (J Trauma Acute Care Surg. 2014;76: 101Y106. Copyright * 2014 by Lippincott Williams & Wilkins) LEVEL OF EVIDENCE: Therapeutic study, level 1. KEY WORDS: Physiotherapy; trauma; rehabilitation; mobility; physical therapy. BACKGROUND:
I
n most countries, trauma is the leading cause of lost years of life and productivity in young adults.1 By 2030, trauma is predicted to be the fifth leading cause of death and the third leading cause of disability globally.2 Modern trauma systems aim to reduce mortality and improve functional outcomes, quality of life, and return to work, school, and family activities. Numerous studies, including a recent meta-analysis, have confirmed a significant reduction in mortality when care is provided at a Level 1 trauma center.1,3,4 However, evidence exists that disability persists in the majority of these patients5Y7 and largely relates to mobility and function.8 Physiotherapy (otherwise known as physical therapy) is integral to modern trauma care.9 Treatment is primarily
Submitted: July 28, 2013, Revised: September 18, 2013011, Accepted: September 23, 2013. From the Department of Physiotherapy (S.C., E.A.B., L.K., M.J.W., C.H., A.E.H), and the Alfred Trauma Service (R.L.G.), The Alfred Hospital; Alfred Health Clinical School, La Trobe University (A.E.H.); Department of Epidemiology and Preventive Medicine (L.K.), Australian and New Zealand Intensive Care Research Centre (C.H.) and Central Clinical School Department of Surgery (R.L.G.), Monash University; and The National Trauma Research Institute (R.L.G.), Melbourne, Victoria, Australia. *S.C. and E.A.B. contributed equally to this study. This study was presented at the National Trauma Research Institute Trauma Conference, November 2012, in Melbourne, Australia, and the Trauma Association of Canada Annual Scientific Meeting, April 11Y13, 2013, in Whistler, British Columbia. Address for reprints: Sara Calthorpe, Department of Physiotherapy, The Alfred Hospital, PO Box 315, Prahran VIC 3181, Australia; email: [email protected]. DOI: 10.1097/TA.0b013e3182ab07c5
concerned with the remediation of impairments and disabilities and the promotion of mobility, functional ability, and quality of life through examination, evaluation, diagnosis, and physical intervention. Previous research has shown that early physiotherapy treatments are effective in improving outcomes in patients with isolated traumatic injuries such as femoral fractures10,11 and ankle fractures.12 Intensive physiotherapy has been shown to improve mobility and reduce length of stay (LOS) in patients with medical, cardiothoracic, and neurologic disorders.13 In two cohort studies,14,15 early or intensive therapy following war-related trauma was shown to improve motor recovery and functional outcomes; however, no randomized controlled trials into the optimal intensity of treatments have yet been conducted in multitrauma populations.16 The primary aim of this study was to investigate the effects of an intensive physiotherapy program on objective measures of patient mobility. The secondary aims were to assess the effect of intensive physiotherapy on the time taken to achieve physical independence and readiness for discharge, hospital LOS, discharge destination, patient confidence and satisfaction, health-related quality of life, and return to work.
PATIENTS AND METHODS Design This was a single-center prospective randomized controlled trial conducted at the Alfred Hospital, a Level 1 trauma
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center in Melbourne, Australia. The Alfred Hospital Trauma Service treats more than half of the state of Victoria’s trauma patients, approximately 5,000 per year, with one in five fitting criteria for major trauma.17 The study was approved by The Alfred Research and Ethics committee (ACTRN12611001231932).
Subjects Between October 2011 and June 2012, we screened for inclusion in the study consecutive patients 18 years and older who were admitted to the Alfred Hospital Trauma Unit. We excluded patients who were unable to participate in active therapy sessions secondary to severe neurologic or cognitive impairment, were unable to walk owing to fracture pattern (i.e., bilaterally nonYweight-bearing lower limbs), required physical assistance (other than a gait aid) to mobilize before the accident, were nursing home residents, had spinal cord injuries or had burns to more than 20% of their body surface area, and those subsequently found to have no physical injuries, were deemed safe for discharge on first physiotherapy review, or were nonYEnglish speaking. Any patient who sustained a head injury as a result of his or her accident was required to pass a routine cognitive test (Westmead Post Traumatic Amnesia Score18) before consent. Patients were eligible for the study within 24 hours of first active mobilization by a physiotherapist, the minimum level being to sit on the edge of the bed with two therapists assisting. Written informed consent was obtained from all participants. Participants were assigned into one of two groups as follows: usual care (UC), one daily treatment session of approximately 30 minutes; or intensive physiotherapy (IP), UC plus two additional treatments of 30-minute duration each day. Those assigned to UC acted as the control group. Randomization was via a computer-generated program, and allocation was concealed using opaque envelopes.
Interventions UC is a tailored physiotherapy treatment that aims to achieve independence in mobility, to allow timely discharge to an appropriate destination (home or inpatient rehabilitation). This involved one or more of bed- and chair-based limb exercises (e.g., strength exercises such as static quadriceps holds), chest physiotherapy (e.g., airway clearance and lung recruitment exercises), and gait retraining (e.g., gait aid practice, balance, walking, and endurance exercises). UC was conducted by physiotherapists who were blinded to trial group allocation. Each treatment was approximately 30 minutes every morning, 7 days per week. Participants in the IP group received two additional treatments per day by an interventional physiotherapist, 7 days per week. One was a 30-minute ward gym session, undertaking a supervised exercise program tailored to the individual including standing, balance and strength exercises, stretches and walking as appropriate. The second treatment involved ward mobility aiming to improve the functional level compared with the previous physiotherapy treatment (e.g., require less therapist assistance, progress from bed transfers to walking, increase walking distance). Patients located in the intensive care unit had the two additional mobility treatments on the ward, rather 102
than in the gym. All physiotherapists received the same training and had a minimum of 1-year experience working in a hospital.
Discharge Criteria Participants were discharged home once they were medically stable, deemed physically ready by the blinded UC physiotherapist and cleared by the multidisciplinary team. Physical readiness was defined as independence in transfers from lying to sitting, bed mobility, transfer from bed to chair and back to bed, walking with or without gait aid as required, and negotiation of any stairs by which the patient can safely enter and exit their home.19 If patients were unable to achieve these criteria before becoming medically stable, they were transferred to a rehabilitation facility as per usual protocol.
Data Collection Demographic data were collected including patient characteristics and injury type. The primary outcome was the modified Iowa Level of Assistance (mILOA) score. The mILOA consists of four mobility tasks (supine to sitting on the edge of the bed, sit to stand, walking, and negotiation of one step), which are graded according to the level of assistance required, use of gait aid, and the distance that can be walked. The ILOA was originally described for patients with hip and knee arthroplasty.20 It was then modified for use in patients following fractured neck of femur.10 Total scores range from 0 to 36, with a score of 0 indicating independence for all items. The ILOA scores were measured by the blinded UC physiotherapist on Days 3 and 5 of enrolment in the study (or the day of discharge if earlier). For those discharged on Days 1 or 2, their scores were analyzed with Day 3 scores and, likewise, Day 4 discharge scores were analyzed with Day 5 scores. Secondary outcomes measures included time from enrolment to physical readiness for discharge (minutes), LOS (acute LOS and combined acute and rehabilitation minutes when appropriate), discharge destination (home or inpatient rehabilitation), and a patient confidence and satisfaction scale (a 4-point scale for confidence with mobility tasks, ability to manage at home, and satisfaction with the amount of physiotherapy treatments). Six-month data collected routinely by the Victorian State Trauma Registry21 and the Victorian Orthopaedic Trauma Outcomes Registry5 were also compared between groups, and all patients were covered by these two registries. This included the SF12 (a self-reported physical and mental health questionnaire found to be reliable and valid in measuring physical and mental outcomes),22 the Glasgow Outcome ScaleYExtended (GOS-E), (recommended for use by trauma registries for monitoring functional outcomes),23 and the EQ-5D score (measuring general health after injury).24 When EQ-5D responses were missing, proxy responses were substituted where available.25
Sample Size In this two-treatment parallel-design study, a total of 90 patients were predicted to be needed to detect a treatment difference with 80% probability at a two-sided 0.05 significance level, if the true difference between the treatment and control groups was 7 points on the mILOA scale, representing the minimal important clinical difference for this outcome.20 * 2014 Lippincott Williams & Wilkins
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TABLE 1. Patient Demographics Patient Characteristic Sex, male Age, y Body mass index, kg/m Publicly funded admission Daily alcohol consumption Current smoker Home alone Employed Premorbid ability to walk 91 block Mechanism of injury Motor vehicle or motorcycle collision Pedestrian/pedal cyclist Fall Other ISS Major trauma (ISS 9 15) Upper-limb fracture Lower-limb fracture Chest injury* Spine injury** Pelvic fracture Required intensive care unit admission
UC (n = 44)
IP (n = 43)
p
29 (66) 54.4 (20.4) 26.7 (4.30) 17 (39) 5 (11) 8 (18) 11 (25) 28 (64) 42 (95)
25 (58) 58.0 (22.2) 27.4 (5.6) 14 (33) 8 (19) 8 (19) 12 (28) 16 (37) 39 (91)
0.46 0.43 0.50 0.55 0.34 0.96 0.76 0.01 0.38 0.41
23 (52) 3 (7) 12 (27) 6 (14) 14.2 (7.2) 18 (41) 9 (20) 16 (36) 22 (50) 28 (64) 7 (16) 10 (23)
20 (47) 7 (16) 14 (33) 2 (5) 13.2 (5.9) 16 (37) 14 (33) 15 (35) 18 (42) 21 (49) 3 (7) 12 (28)
0.47 0.79 0.20 0.89 0.45 0.16 0.19 0.58
Data are presented as n (%) or mean (SD). p value is difference between control and intervention groups. *Cardiac contusion, pulmonary contusion, rib fractures, sternal/manubrial fractures, pneumothorax, hemopneumothorax, pneumomediastinum. **Fracture or ligament tear.
This was based on the assumption that the SD of the response variable was 11.6 units.26
Statistical Analysis Analysis was performed using SPSS version 17.0 (IBM, Chicago, IL). Data are presented as means and SDs or medians and interquartile ranges (IQRs) for data which were not
normally distributed. Differences between groups at baseline were examined using independent samples t tests for continuous data and W2 test for categorical data. Data for the outcomes of mILOA and LOS were not normally distributed, so these variables were natural log transformed. Differences between groups for outcome variables were compared using univariate analysis of variance for continuous variables and W2 test for categorical variables. The GOS-E data were analyzed using ordinal logistic regression.
RESULTS Between October 2011 and June 2012, 90 patients were recruited to the study, with 45 patients randomized into each group. Three patients were withdrawn from the study owing to evolution of medical issues excluding them from further participation, and one patient withdrew himself or herself. Overall, 54 males (62%) were recruited, and half of the patients were involved in a motor vehicle collision. Demographic and injury data comparing the two groups are presented in Table 1. There was no difference between the two groups for any factor except for preinjury employment status ( p = 0.01), with the experimental group less likely to be employed. Results are presented in Tables 2Y4. Patients in the IP group received significantly more physiotherapy treatment time ( p G 0.005). The primary outcome measure (mILOA) was significantly better in the IP group than in UC group at Day 3 (median, 7 points compared with 10 points; p = 0.02) and Day 5 (median, 7.5 points compared with 16 points; p = 0.04), with the latter exceeding the minimal clinically important difference (8.5 points).20 Time to physical readiness for discharge and LOS varied greatly between individuals with no overall difference between groups. However, post hoc subgroup analysis showed that for those patients with an Injury Severity Score (ISS) greater than 15, the time to physical readiness for discharge was significantly shorter in the intervention group (median, 4,053 min [IQR, 1,853Y10,759 minutes] vs. 11,467 [5,111Y35,915 minutes]; p = 0.049). Similarly, in those who
TABLE 2. Results Outcome Measures Total physiotherapy treatment time, min mILOA e Day 3 mILOA Q Day 5 (n = 46) Enrolment to physical readiness, min Acute hospital LOS, min Total LOS all patients, min Rehabilitation LOS, min (n = 27) Combined acute and rehabilitation LOS, min (n = 27) Discharge destination Home Rehabilitation Other* Death during admission
UC (n = 44)
IP (n = 43)
p
58 (30Y95) 10.0 (4Y19) 16 (4Y24) 5,686 (2,613Y13,012) 8,716 (6,213Y16,089) 12,996 (7,222Y48,100) 38,051 (23,349Y66,346) 53,918 (33,853Y91,502)
124 (80Y275) 7 (1Y15) 7.5 (2Y15) 4,140 (15,68Y11,368) 11,269 (6,663Y16,726) 16,726 (8,116Y34,861) 28,679 (17,956Y40,819) 39,013 (32,826Y76,278)
0.005 0.02 0.04 0.38 0.78 0.87 0.64 0.64 0.76
27 (61) 15 (34) 2 (5) 0
28 (65) 12 (28) 3 (7) 0
1
Data are presented as median (IQR) or n (%). Data for mILOA and LOS variables were natural log transformed before analysis. p values represent between-group comparison. *Discharged destination not home or rehabilitation, for example, facility with higher level of care or with family.
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DISCUSSION
TABLE 3. Satisfaction and Confidence With Treatment Questionnaire Question Satisfaction with treatment Not satisfied Somewhat satisfied Satisfied Very satisfied Confidence with mobility Not confident Somewhat confident Confident Highly confident Confidence with managing at home Not confident Somewhat confident Confident Highly confident
UC (n = 41)*
IP (n = 41)*
0 2 (5) 23 (56) 16 (39)
0 3 (7) 10 (24) 28 (68)
2 8 27 4
(5) (20) (66) (10)
3 (7) 8 (20) 23 (56) 7 (17)
3 19 15 4
(7) (46) (37) (10)
7 (17) 11 (27) 14 (34) 9 (22)
p 0.01
0.72
0.13
Data are presented as n (%). p values represent between-group comparison. *Incomplete data.
were not full weight bearing, there was a trend toward decreased LOS in rehabilitation for the intervention group (median, 21,585 minutes [IQR, 15,555Y37,567 minutes] vs. 53,935 minutes [23,700Y86,962 minutes]; p = 0.075). No other effects of baseline demographic features on time to readiness for discharge or LOS variables were evident. Fifteen participants in the UC group and 12 participants in the IP group required rehabilitation hospital admission. There was no significant difference in discharge destination between groups, and there were no deaths in either group. Participants in the IP group were more satisfied with the amount of physiotherapy received ( p = 0.01). The EQ-5D scores were completed by proxies for seven people in the UC group and four people in the IP group ( p = 0.35). There were no significant differences between groups for the GOS-E or any quality-of-life outcome (Table 4).
This study showed that trauma patients who participate in an intensive physiotherapy program achieved better functional mobility at Days 3 and 5 of their acute hospital admission. No differences in LOS or discharge destination were evident in this relatively small study. This seems to be the first randomized controlled trial to provide evidence regarding the functional outcomes of intensive physiotherapy rehabilitation following major trauma. Long-term studies have previously found that mobility and function are the main areas of disability following trauma8 and remain the patients’ primary concern 1 year on.27 In this trial, the clinically significant improvement in the mILOA in the IP group reflected a more independent and mobile population compared with the UC group. We suspect that this improvement leads to less demand for assistance from other staff members. The length of hospital stay was not different between the groups in this study. Many factors influence LOS, including functional independence, discharge destination, and insurance status.28 The acute hospital LOS in this study did not differ between groups, although the median of 6.5-day reduction in rehabilitation LOS and the 10.3-day difference in total LOS for participants requiring rehabilitation may be clinically and financially significant. Given that this study involves a group of patients who consume large amounts of health care resources,9 this outcome may be very important to the hospital system. Post hoc subgroup analyses suggest that this intervention might be particularly beneficial for those with more severe injuries and who are not able to fully weight bear, although these findings should be confirmed in a future study. While this study was a single-institution study, it included a heterogeneous group of patients with multiple injuries, which is likely to reflect diverse patient populations in most trauma services in which blunt trauma is the predominant mechanism. Furthermore, this study used a robust study design with randomization and concealed allocation; blinded outcome assessment, which is a critical element of good trial design in studies of physical interventions; and a high rate of follow-up.
TABLE 4. Quality-of-Life Outcomes Outcome Measures GOS-E Median (IQR) EQ-5D Mobility problems Self-care problems Usual activities problems Pain or discomfort Anxiety or depression Visual analogue scale (n = 69), median (IQR) SF-12 Physical score, median (IQR) Mental score, median (IQR)
Control
Intervention
n = 39 6 (5Y6) n = 39 20 (51) 10 (26) 10 (26) 23 (59) 13 (33) 70 (50Y86) n = 32 33 (26Y56) 55 (50Y58)
n = 34 6 (3Y7) n = 34 14 (41) 10 (29) 12 (35) 17 (50) 15 (44) 70 (50 Y75) n = 25 36 (29 Y49) 54 (37Y58)
p 0.65 0.39 0.72 0.37 0.44 0.35 0.19 0.96 0.37
Data are presented as n (%) except where indicated. EQ-5D data are n (%) reporting problems in each domain at 6 months following injury.
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However, this study also had some limitations. There is no validated outcome measure for physical function in the trauma population. We chose to use the mILOA because this has been used in a previous study where the main outcome was patient function following hip surgery.10 Although the relationship of the mILOA to longer-term outcomes and other important end points following trauma is not known, it proved to be a sensitive tool for detecting early changes in function in this study. This Phase 2 study was not powered to detect differences in more meaningful end points such as physical readiness for discharge, LOS, or quality of life; further studies across multiple sites and with larger numbers will be required to answer the important question of whether an earlier physical independence reflects positively on these outcomes. It also did not include an economic analysis, which would guide decision makers about the value of investing in more physiotherapy services.
CONCLUSION This study showed that intensive inpatient physiotherapy following traumatic injury resulted in improved physical function at Days 3 and 5 following hospital admission. Future studies are needed to identify whether this early improvement in function results in long-term functional recovery, higher rates of return to work, and better quality of life in patients following major trauma. AUTHORSHIP S.C., E.A.B., L.K., M.J.W., C.H., A.E.H., and R.L.G. provided the trial design. S.C., E.A.B., L.K., and M.J.W. performed the literature search. S.C., E.A.B., and L.K. performed the data acquisition. S.C., E.A.B., L.K., M.J.W., C.H., A.E.H., and R.L.G. performed the data analysis and interpretation. S.C., E.A.B., L.K., M.J.W., C.H., A.E.H., and R.L.G. reviewed the manuscript.
ACKNOWLEDGMENT We thank Andrew Corcoran, Jonathon Prescott, Rebecca Robinson and Jane Elliott. We also thank the Victorian State Trauma Outcome Registry and Monitoring (VSTORM) group for the provision of VSTR data.
DISCLOSURE This trial was funded by the Sir Edmund Herring Memorial Scholarship, Royal Automobile Club of Victoria, received by S.C. and E.A.B. For the remaining authors, no conflicts were declared. The Victorian State Trauma Registry (VSTR) is a Department of Health, State Government of Victoria and Transport Accident CommissionYfunded project. VOTOR is funded by the TAC via the Institute for Safety, Compensation and Recovery Research. R.L.G. is supported by a Practitioner Fellowship of the Australian National Health and Medical Research Council. C.H. is supported by an Early Career Research Fellowship from the Australian National Health and Medical Research Council.
REFERENCES 1. Celso B, Tepas J, Langland-Orban B, Pracht E, Papa L, Lottenberg L, Flint L. A systematic review and meta-analysis comparing outcome of severely injured patients treated in trauma centres following the establishment of trauma systems. J Trauma. 2006;60:371Y378.
2. World Health Organisation. The Global Burden of Disease 2004 Update. Available at: http://www.who.int/healthinfo/global_burden_disease/GBD_ report_2004update_full.pdf. Accessed March 4, 2013. 3. Cameron P, Gabbe B, Cooper D, Walker T, Judson R, McNeil J. A statewide system of trauma care in Victoria: effect on patient survival. Med J Aust. 2008;189:546Y550. 4. MacKenzie EJ, Rivara FP, Jurkovich GJ, Nathens AB, Egleston BL, Salkever DS, Frey KP, Scharfstein DO. The impact of trauma-centre care on functional outcomes following major lower limb trauma. J Bone Joint Surg Am. 2008;90:101Y109. 5. Urquhart DM, Williamson OD, Gabbe BJ, Cicuttini FM, Cameron PA, Richardson MD, Edwards ER. Outcomes of patients with orthopaedic trauma admitted to level 1 trauma centres. ANZ J Surg. 2006;76:600Y606. 6. Vales WJ, Steyerberg EW, Essink-Bot ML, van Beeck EF, Meeuwis JD, Leenen LPH. Prevalence and determinants of disabilities and return to work after major trauma. J Trauma. 2005;58:126Y135. 7. Balogh ZJ, Reumann MK, Gruen RL, Mayer-Kuckuk PM, Schuetz MA, Harris IA, Gabbe BJ, Bhandari M. Advances and future directions for management of trauma patients with musculoskeletal injuries. Lancet. 2012;380:1109Y1119. 8. Holstag HR, van Beek EF, Lindeman E, Leenen LPH. Determinants of long-term functional consequences after major trauma. J Trauma. 2007;62: 919Y927. 9. Dutton RP, Cooper C, Jones A, Leone S, Kramer ME, Scalea TM. Daily multidisciplinary rounds shorten length of stay for trauma patients. J Trauma. 2003;55:913Y919. 10. Oldmeadow LB, Edwards ER, Kimmel LA, Kipen E, Robertson VJ, Bailey MJ. No rest for the wounded: early ambulation after hip surgery accelerates recovery. ANZ J Surg. 2006;76:607Y611. 11. Pendleton AM, Cannada LK, Guerrero-Bejarano M. Factors affecting length of stay after isolated femoral shaft fractures. J Trauma. 2007;62: 697Y700. 12. Kimmel LA, Edwards ER, Liew SM, Oldmeadow LB, Webb MJ, Holland AE. Rest easy? Is bed rest really necessary after surgical repair of an ankle fracture? Injury. 2012;43:766Y771. 13. Peiris CL, Taylor NF, Shields N. Extra physical therapy reduces patient length of stay and improves functional outcomes and quality of life in people with acute or subacute conditions: a systematic review. Arch Phys Med Rehabil. 2011;92:1490Y1500. 14. Siddharthan K, Scott S, Bass E, Nelson A. Rehabilitation outcomes for veterans with polytrauma treated at the Tampa VA. Rehabil Nurs. 2008;33: 221Y225. 15. Sayer NA, Chiros CE, Sigford B, Scott S, Clothier B, Pickett T, et al. Characteristics and rehabilitation outcomes among patients with blast and other injuries sustained during the Global War on Terror. Arch Phys Med Rehabil. 2008;89:163Y170. 16. Khan F, Amatya B, Hoffman K. Systematic review of multidisciplinary rehabilitation in patients with multiple trauma. Br J Surg. 2012; 99:88Y96. 17. The Alfred Hospital. Trauma RegistryVTrauma Admission Activity 1st July 2008Y30th June 2009. Available at: www.alfred.org.au/traumaservice. Accessed October 10, 2012. 18. Shores EA, Marosszeky JE, Sandanam J, Batchelor J. Preliminary validation of a clinical scale for measuring the duration of post-traumatic amnesia. Med J Aust. 1988;144:569Y572. 19. Kimmel L, Oldmeadow L, Sage C, Liew S, Holland A. A designated three day elective orthopaedic surgery unit: first year’s results for hip and knee replacement patients. Int J Orthop Trauma Nurs. 2011; 15:29Y34. 20. Shields RK, Enloe LJ, Evans RE, Smith KB, Steckel SD. Reliability, validity, and responsiveness of functional tests in patients with total joint replacements. Phys Ther. 1995;75:169Y179. 21. Gabbe B, Sutherland A, Hart M, Cameron P. Population-based capture of long-term functional and quality of life outcomes after major trauma: the experiences of the Victorian State Trauma Registry. J Trauma. 2010;69: 532Y536. 22. Ware JE, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220Y233.
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26. Jesudason C, Stiller C. Are bed exercises really necessary following hip arthroplasty? Aust J Physiother. 2002;48:73Y81. 27. Zatzick D, Sun-Mee K, Hinton LW, Kelly RH, Hilty DM, Franz CE, Le L, Kravitz RL. Posttraumatic concerns: a patient-centred approach to outcome assessment after traumatic physical injury. Med Care. 2001;39: 327Y339. 28. Brasel KJ, Lim HJ, Nirula R, Weigelt JA. Length of stay: an appropriate quality measure? Arch Surg. 2007;142:461Y466.
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An intensive physiotherapy program improves mobility for trauma patients Sara Calthorpe, BSc (Hons), Elizabeth A. Barber, BPhysio (Hons), Anne E. Holland, PhD, Lara Kimmel, BPhysio, Melissa J. Webb, MHSc, Carol Hodgson, PhD, and Russell L. Gruen, PhD, Melbourne, Victoria, Australia Physiotherapy is integral to modern trauma care. Early physiotherapy and mobility have been shown to improve outcomes in patients with isolated injuries; however, the optimal intensity of physiotherapy in the multitrauma patient population has not yet been examined. The primary aim of this study was to determine whether an intensive physiotherapy program resulted in improved inpatient mobility. METHODS: We conducted a single-center prospective randomized controlled study of 90 consecutive patients admitted to the Alfred Hospital (a Level 1 trauma center) in Australia between October 2011 and June 2012 who could participate in ward-based physiotherapy. Participants were allocated to either usual care (daily physiotherapy treatment, approximately 30 minutes) or intensive physiotherapy (usual care plus two additional 30-minute treatments each day). The primary outcome measure was the modified Iowa Level of Assistance (mILOA) score, collected by a blinded assessor at Days 3 and 5 (or earlier if discharged). Secondary measures included physical readiness for discharge, hospital and rehabilitation length of stay, a patient confidence and satisfaction scale, and quality of life at 6 months. RESULTS: Groups were comparable at baseline. Participants in the intensive physiotherapy group achieved significantly improved mILOA scores on Day 3 (median, 7 points compared with 10 points; p = 0.02) and Day 5 (median, 7.5 points compared with 16 points; p = 0.04) and were more satisfied with their care ( p = 0.01). There was no difference between groups in time to physical readiness, discharge destination, length of stay, or quality-of-life measures. CONCLUSION: Intensive physiotherapy resulted in improved mobility in trauma inpatients. Further studies are required to determine if specific groups benefit more from intensive physiotherapy and if this translates to long-term improvements in outcomes. (J Trauma Acute Care Surg. 2014;76: 101Y106. Copyright * 2014 by Lippincott Williams & Wilkins) LEVEL OF EVIDENCE: Therapeutic study, level 1. KEY WORDS: Physiotherapy; trauma; rehabilitation; mobility; physical therapy. BACKGROUND:
I
n most countries, trauma is the leading cause of lost years of life and productivity in young adults.1 By 2030, trauma is predicted to be the fifth leading cause of death and the third leading cause of disability globally.2 Modern trauma systems aim to reduce mortality and improve functional outcomes, quality of life, and return to work, school, and family activities. Numerous studies, including a recent meta-analysis, have confirmed a significant reduction in mortality when care is provided at a Level 1 trauma center.1,3,4 However, evidence exists that disability persists in the majority of these patients5Y7 and largely relates to mobility and function.8 Physiotherapy (otherwise known as physical therapy) is integral to modern trauma care.9 Treatment is primarily
Submitted: July 28, 2013, Revised: September 18, 2013011, Accepted: September 23, 2013. From the Department of Physiotherapy (S.C., E.A.B., L.K., M.J.W., C.H., A.E.H), and the Alfred Trauma Service (R.L.G.), The Alfred Hospital; Alfred Health Clinical School, La Trobe University (A.E.H.); Department of Epidemiology and Preventive Medicine (L.K.), Australian and New Zealand Intensive Care Research Centre (C.H.) and Central Clinical School Department of Surgery (R.L.G.), Monash University; and The National Trauma Research Institute (R.L.G.), Melbourne, Victoria, Australia. *S.C. and E.A.B. contributed equally to this study. This study was presented at the National Trauma Research Institute Trauma Conference, November 2012, in Melbourne, Australia, and the Trauma Association of Canada Annual Scientific Meeting, April 11Y13, 2013, in Whistler, British Columbia. Address for reprints: Sara Calthorpe, Department of Physiotherapy, The Alfred Hospital, PO Box 315, Prahran VIC 3181, Australia; email: [email protected]. DOI: 10.1097/TA.0b013e3182ab07c5
concerned with the remediation of impairments and disabilities and the promotion of mobility, functional ability, and quality of life through examination, evaluation, diagnosis, and physical intervention. Previous research has shown that early physiotherapy treatments are effective in improving outcomes in patients with isolated traumatic injuries such as femoral fractures10,11 and ankle fractures.12 Intensive physiotherapy has been shown to improve mobility and reduce length of stay (LOS) in patients with medical, cardiothoracic, and neurologic disorders.13 In two cohort studies,14,15 early or intensive therapy following war-related trauma was shown to improve motor recovery and functional outcomes; however, no randomized controlled trials into the optimal intensity of treatments have yet been conducted in multitrauma populations.16 The primary aim of this study was to investigate the effects of an intensive physiotherapy program on objective measures of patient mobility. The secondary aims were to assess the effect of intensive physiotherapy on the time taken to achieve physical independence and readiness for discharge, hospital LOS, discharge destination, patient confidence and satisfaction, health-related quality of life, and return to work.
PATIENTS AND METHODS Design This was a single-center prospective randomized controlled trial conducted at the Alfred Hospital, a Level 1 trauma
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center in Melbourne, Australia. The Alfred Hospital Trauma Service treats more than half of the state of Victoria’s trauma patients, approximately 5,000 per year, with one in five fitting criteria for major trauma.17 The study was approved by The Alfred Research and Ethics committee (ACTRN12611001231932).
Subjects Between October 2011 and June 2012, we screened for inclusion in the study consecutive patients 18 years and older who were admitted to the Alfred Hospital Trauma Unit. We excluded patients who were unable to participate in active therapy sessions secondary to severe neurologic or cognitive impairment, were unable to walk owing to fracture pattern (i.e., bilaterally nonYweight-bearing lower limbs), required physical assistance (other than a gait aid) to mobilize before the accident, were nursing home residents, had spinal cord injuries or had burns to more than 20% of their body surface area, and those subsequently found to have no physical injuries, were deemed safe for discharge on first physiotherapy review, or were nonYEnglish speaking. Any patient who sustained a head injury as a result of his or her accident was required to pass a routine cognitive test (Westmead Post Traumatic Amnesia Score18) before consent. Patients were eligible for the study within 24 hours of first active mobilization by a physiotherapist, the minimum level being to sit on the edge of the bed with two therapists assisting. Written informed consent was obtained from all participants. Participants were assigned into one of two groups as follows: usual care (UC), one daily treatment session of approximately 30 minutes; or intensive physiotherapy (IP), UC plus two additional treatments of 30-minute duration each day. Those assigned to UC acted as the control group. Randomization was via a computer-generated program, and allocation was concealed using opaque envelopes.
Interventions UC is a tailored physiotherapy treatment that aims to achieve independence in mobility, to allow timely discharge to an appropriate destination (home or inpatient rehabilitation). This involved one or more of bed- and chair-based limb exercises (e.g., strength exercises such as static quadriceps holds), chest physiotherapy (e.g., airway clearance and lung recruitment exercises), and gait retraining (e.g., gait aid practice, balance, walking, and endurance exercises). UC was conducted by physiotherapists who were blinded to trial group allocation. Each treatment was approximately 30 minutes every morning, 7 days per week. Participants in the IP group received two additional treatments per day by an interventional physiotherapist, 7 days per week. One was a 30-minute ward gym session, undertaking a supervised exercise program tailored to the individual including standing, balance and strength exercises, stretches and walking as appropriate. The second treatment involved ward mobility aiming to improve the functional level compared with the previous physiotherapy treatment (e.g., require less therapist assistance, progress from bed transfers to walking, increase walking distance). Patients located in the intensive care unit had the two additional mobility treatments on the ward, rather 102
than in the gym. All physiotherapists received the same training and had a minimum of 1-year experience working in a hospital.
Discharge Criteria Participants were discharged home once they were medically stable, deemed physically ready by the blinded UC physiotherapist and cleared by the multidisciplinary team. Physical readiness was defined as independence in transfers from lying to sitting, bed mobility, transfer from bed to chair and back to bed, walking with or without gait aid as required, and negotiation of any stairs by which the patient can safely enter and exit their home.19 If patients were unable to achieve these criteria before becoming medically stable, they were transferred to a rehabilitation facility as per usual protocol.
Data Collection Demographic data were collected including patient characteristics and injury type. The primary outcome was the modified Iowa Level of Assistance (mILOA) score. The mILOA consists of four mobility tasks (supine to sitting on the edge of the bed, sit to stand, walking, and negotiation of one step), which are graded according to the level of assistance required, use of gait aid, and the distance that can be walked. The ILOA was originally described for patients with hip and knee arthroplasty.20 It was then modified for use in patients following fractured neck of femur.10 Total scores range from 0 to 36, with a score of 0 indicating independence for all items. The ILOA scores were measured by the blinded UC physiotherapist on Days 3 and 5 of enrolment in the study (or the day of discharge if earlier). For those discharged on Days 1 or 2, their scores were analyzed with Day 3 scores and, likewise, Day 4 discharge scores were analyzed with Day 5 scores. Secondary outcomes measures included time from enrolment to physical readiness for discharge (minutes), LOS (acute LOS and combined acute and rehabilitation minutes when appropriate), discharge destination (home or inpatient rehabilitation), and a patient confidence and satisfaction scale (a 4-point scale for confidence with mobility tasks, ability to manage at home, and satisfaction with the amount of physiotherapy treatments). Six-month data collected routinely by the Victorian State Trauma Registry21 and the Victorian Orthopaedic Trauma Outcomes Registry5 were also compared between groups, and all patients were covered by these two registries. This included the SF12 (a self-reported physical and mental health questionnaire found to be reliable and valid in measuring physical and mental outcomes),22 the Glasgow Outcome ScaleYExtended (GOS-E), (recommended for use by trauma registries for monitoring functional outcomes),23 and the EQ-5D score (measuring general health after injury).24 When EQ-5D responses were missing, proxy responses were substituted where available.25
Sample Size In this two-treatment parallel-design study, a total of 90 patients were predicted to be needed to detect a treatment difference with 80% probability at a two-sided 0.05 significance level, if the true difference between the treatment and control groups was 7 points on the mILOA scale, representing the minimal important clinical difference for this outcome.20 * 2014 Lippincott Williams & Wilkins
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TABLE 1. Patient Demographics Patient Characteristic Sex, male Age, y Body mass index, kg/m Publicly funded admission Daily alcohol consumption Current smoker Home alone Employed Premorbid ability to walk 91 block Mechanism of injury Motor vehicle or motorcycle collision Pedestrian/pedal cyclist Fall Other ISS Major trauma (ISS 9 15) Upper-limb fracture Lower-limb fracture Chest injury* Spine injury** Pelvic fracture Required intensive care unit admission
UC (n = 44)
IP (n = 43)
p
29 (66) 54.4 (20.4) 26.7 (4.30) 17 (39) 5 (11) 8 (18) 11 (25) 28 (64) 42 (95)
25 (58) 58.0 (22.2) 27.4 (5.6) 14 (33) 8 (19) 8 (19) 12 (28) 16 (37) 39 (91)
0.46 0.43 0.50 0.55 0.34 0.96 0.76 0.01 0.38 0.41
23 (52) 3 (7) 12 (27) 6 (14) 14.2 (7.2) 18 (41) 9 (20) 16 (36) 22 (50) 28 (64) 7 (16) 10 (23)
20 (47) 7 (16) 14 (33) 2 (5) 13.2 (5.9) 16 (37) 14 (33) 15 (35) 18 (42) 21 (49) 3 (7) 12 (28)
0.47 0.79 0.20 0.89 0.45 0.16 0.19 0.58
Data are presented as n (%) or mean (SD). p value is difference between control and intervention groups. *Cardiac contusion, pulmonary contusion, rib fractures, sternal/manubrial fractures, pneumothorax, hemopneumothorax, pneumomediastinum. **Fracture or ligament tear.
This was based on the assumption that the SD of the response variable was 11.6 units.26
Statistical Analysis Analysis was performed using SPSS version 17.0 (IBM, Chicago, IL). Data are presented as means and SDs or medians and interquartile ranges (IQRs) for data which were not
normally distributed. Differences between groups at baseline were examined using independent samples t tests for continuous data and W2 test for categorical data. Data for the outcomes of mILOA and LOS were not normally distributed, so these variables were natural log transformed. Differences between groups for outcome variables were compared using univariate analysis of variance for continuous variables and W2 test for categorical variables. The GOS-E data were analyzed using ordinal logistic regression.
RESULTS Between October 2011 and June 2012, 90 patients were recruited to the study, with 45 patients randomized into each group. Three patients were withdrawn from the study owing to evolution of medical issues excluding them from further participation, and one patient withdrew himself or herself. Overall, 54 males (62%) were recruited, and half of the patients were involved in a motor vehicle collision. Demographic and injury data comparing the two groups are presented in Table 1. There was no difference between the two groups for any factor except for preinjury employment status ( p = 0.01), with the experimental group less likely to be employed. Results are presented in Tables 2Y4. Patients in the IP group received significantly more physiotherapy treatment time ( p G 0.005). The primary outcome measure (mILOA) was significantly better in the IP group than in UC group at Day 3 (median, 7 points compared with 10 points; p = 0.02) and Day 5 (median, 7.5 points compared with 16 points; p = 0.04), with the latter exceeding the minimal clinically important difference (8.5 points).20 Time to physical readiness for discharge and LOS varied greatly between individuals with no overall difference between groups. However, post hoc subgroup analysis showed that for those patients with an Injury Severity Score (ISS) greater than 15, the time to physical readiness for discharge was significantly shorter in the intervention group (median, 4,053 min [IQR, 1,853Y10,759 minutes] vs. 11,467 [5,111Y35,915 minutes]; p = 0.049). Similarly, in those who
TABLE 2. Results Outcome Measures Total physiotherapy treatment time, min mILOA e Day 3 mILOA Q Day 5 (n = 46) Enrolment to physical readiness, min Acute hospital LOS, min Total LOS all patients, min Rehabilitation LOS, min (n = 27) Combined acute and rehabilitation LOS, min (n = 27) Discharge destination Home Rehabilitation Other* Death during admission
UC (n = 44)
IP (n = 43)
p
58 (30Y95) 10.0 (4Y19) 16 (4Y24) 5,686 (2,613Y13,012) 8,716 (6,213Y16,089) 12,996 (7,222Y48,100) 38,051 (23,349Y66,346) 53,918 (33,853Y91,502)
124 (80Y275) 7 (1Y15) 7.5 (2Y15) 4,140 (15,68Y11,368) 11,269 (6,663Y16,726) 16,726 (8,116Y34,861) 28,679 (17,956Y40,819) 39,013 (32,826Y76,278)
0.005 0.02 0.04 0.38 0.78 0.87 0.64 0.64 0.76
27 (61) 15 (34) 2 (5) 0
28 (65) 12 (28) 3 (7) 0
1
Data are presented as median (IQR) or n (%). Data for mILOA and LOS variables were natural log transformed before analysis. p values represent between-group comparison. *Discharged destination not home or rehabilitation, for example, facility with higher level of care or with family.
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DISCUSSION
TABLE 3. Satisfaction and Confidence With Treatment Questionnaire Question Satisfaction with treatment Not satisfied Somewhat satisfied Satisfied Very satisfied Confidence with mobility Not confident Somewhat confident Confident Highly confident Confidence with managing at home Not confident Somewhat confident Confident Highly confident
UC (n = 41)*
IP (n = 41)*
0 2 (5) 23 (56) 16 (39)
0 3 (7) 10 (24) 28 (68)
2 8 27 4
(5) (20) (66) (10)
3 (7) 8 (20) 23 (56) 7 (17)
3 19 15 4
(7) (46) (37) (10)
7 (17) 11 (27) 14 (34) 9 (22)
p 0.01
0.72
0.13
Data are presented as n (%). p values represent between-group comparison. *Incomplete data.
were not full weight bearing, there was a trend toward decreased LOS in rehabilitation for the intervention group (median, 21,585 minutes [IQR, 15,555Y37,567 minutes] vs. 53,935 minutes [23,700Y86,962 minutes]; p = 0.075). No other effects of baseline demographic features on time to readiness for discharge or LOS variables were evident. Fifteen participants in the UC group and 12 participants in the IP group required rehabilitation hospital admission. There was no significant difference in discharge destination between groups, and there were no deaths in either group. Participants in the IP group were more satisfied with the amount of physiotherapy received ( p = 0.01). The EQ-5D scores were completed by proxies for seven people in the UC group and four people in the IP group ( p = 0.35). There were no significant differences between groups for the GOS-E or any quality-of-life outcome (Table 4).
This study showed that trauma patients who participate in an intensive physiotherapy program achieved better functional mobility at Days 3 and 5 of their acute hospital admission. No differences in LOS or discharge destination were evident in this relatively small study. This seems to be the first randomized controlled trial to provide evidence regarding the functional outcomes of intensive physiotherapy rehabilitation following major trauma. Long-term studies have previously found that mobility and function are the main areas of disability following trauma8 and remain the patients’ primary concern 1 year on.27 In this trial, the clinically significant improvement in the mILOA in the IP group reflected a more independent and mobile population compared with the UC group. We suspect that this improvement leads to less demand for assistance from other staff members. The length of hospital stay was not different between the groups in this study. Many factors influence LOS, including functional independence, discharge destination, and insurance status.28 The acute hospital LOS in this study did not differ between groups, although the median of 6.5-day reduction in rehabilitation LOS and the 10.3-day difference in total LOS for participants requiring rehabilitation may be clinically and financially significant. Given that this study involves a group of patients who consume large amounts of health care resources,9 this outcome may be very important to the hospital system. Post hoc subgroup analyses suggest that this intervention might be particularly beneficial for those with more severe injuries and who are not able to fully weight bear, although these findings should be confirmed in a future study. While this study was a single-institution study, it included a heterogeneous group of patients with multiple injuries, which is likely to reflect diverse patient populations in most trauma services in which blunt trauma is the predominant mechanism. Furthermore, this study used a robust study design with randomization and concealed allocation; blinded outcome assessment, which is a critical element of good trial design in studies of physical interventions; and a high rate of follow-up.
TABLE 4. Quality-of-Life Outcomes Outcome Measures GOS-E Median (IQR) EQ-5D Mobility problems Self-care problems Usual activities problems Pain or discomfort Anxiety or depression Visual analogue scale (n = 69), median (IQR) SF-12 Physical score, median (IQR) Mental score, median (IQR)
Control
Intervention
n = 39 6 (5Y6) n = 39 20 (51) 10 (26) 10 (26) 23 (59) 13 (33) 70 (50Y86) n = 32 33 (26Y56) 55 (50Y58)
n = 34 6 (3Y7) n = 34 14 (41) 10 (29) 12 (35) 17 (50) 15 (44) 70 (50 Y75) n = 25 36 (29 Y49) 54 (37Y58)
p 0.65 0.39 0.72 0.37 0.44 0.35 0.19 0.96 0.37
Data are presented as n (%) except where indicated. EQ-5D data are n (%) reporting problems in each domain at 6 months following injury.
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However, this study also had some limitations. There is no validated outcome measure for physical function in the trauma population. We chose to use the mILOA because this has been used in a previous study where the main outcome was patient function following hip surgery.10 Although the relationship of the mILOA to longer-term outcomes and other important end points following trauma is not known, it proved to be a sensitive tool for detecting early changes in function in this study. This Phase 2 study was not powered to detect differences in more meaningful end points such as physical readiness for discharge, LOS, or quality of life; further studies across multiple sites and with larger numbers will be required to answer the important question of whether an earlier physical independence reflects positively on these outcomes. It also did not include an economic analysis, which would guide decision makers about the value of investing in more physiotherapy services.
CONCLUSION This study showed that intensive inpatient physiotherapy following traumatic injury resulted in improved physical function at Days 3 and 5 following hospital admission. Future studies are needed to identify whether this early improvement in function results in long-term functional recovery, higher rates of return to work, and better quality of life in patients following major trauma. AUTHORSHIP S.C., E.A.B., L.K., M.J.W., C.H., A.E.H., and R.L.G. provided the trial design. S.C., E.A.B., L.K., and M.J.W. performed the literature search. S.C., E.A.B., and L.K. performed the data acquisition. S.C., E.A.B., L.K., M.J.W., C.H., A.E.H., and R.L.G. performed the data analysis and interpretation. S.C., E.A.B., L.K., M.J.W., C.H., A.E.H., and R.L.G. reviewed the manuscript.
ACKNOWLEDGMENT We thank Andrew Corcoran, Jonathon Prescott, Rebecca Robinson and Jane Elliott. We also thank the Victorian State Trauma Outcome Registry and Monitoring (VSTORM) group for the provision of VSTR data.
DISCLOSURE This trial was funded by the Sir Edmund Herring Memorial Scholarship, Royal Automobile Club of Victoria, received by S.C. and E.A.B. For the remaining authors, no conflicts were declared. The Victorian State Trauma Registry (VSTR) is a Department of Health, State Government of Victoria and Transport Accident CommissionYfunded project. VOTOR is funded by the TAC via the Institute for Safety, Compensation and Recovery Research. R.L.G. is supported by a Practitioner Fellowship of the Australian National Health and Medical Research Council. C.H. is supported by an Early Career Research Fellowship from the Australian National Health and Medical Research Council.
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