RESEARCH ARTICLE
Feasibility of SaeboFlex Upper-limb Training in Acute Stroke Rehabilitation: A Clinical Case Series‡ Rebecca A. Stuck, Lisa M. Marshall*† & Ramachandran Sivakumar Division of Stroke Medicine, Colchester Hospital University Foundation NHS Trust, Colchester, UK
Abstract Upper-limb (UL) recovery following stroke is often poor. UL rehabilitation therefore continues to be a major focus for occupational therapy. Published evidence for the effectiveness of SaeboFlex training in acute stroke rehabilitation is scarce. The purpose of this study is to explore the feasibility and patient experience of SaeboFlex training in acute stroke. This feasibility study recruited stroke patients (< 84 days post-stroke) with moderate/severe UL weakness. They participated in SaeboFlex sessions for 12 weeks in addition to conventional rehabilitation. A battery of measures was taken at baseline, 4, 8 and 12 weeks. Eight participants were recruited. For the action research arm test score and UL Motricity Index, clinically significant improvements were noted in five out of seven (71%) and six out of seven participants (86%) respectively. Clinically significant improvements were also noted in secondary outcomes. Shoulder complications occurred in one participant. SaeboFlex training facilitated clinically significant improvements in UL function. It has the potential to improve participation and independence in ADLs, reduce carer burden and associated costs. Being a feasibility study with no control arm, we urge caution in interpreting these results. Future research is needed to evaluate the efficacy, optimum dosage and impact on dependency levels of SaeboFlex training as part of a randomized controlled trial Copyright © 2014 John Wiley & Sons, Ltd. Received 30 September 2013; Revised 11 February 2014; Accepted 6 March 2014
Keywords SaeboFlex; upper limb; stroke rehabilitation *Correspondence Lisa Marshall, Stroke Unit, Colchester Hospital University Foundation NHS Trust, Turner Road, Colchester, Essex, CO4 5JL, UK. †
Email: [email protected]
‡
Ethics Reference number: 11/H0302/8
Published online 24 April 2014 in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/oti.1369
Introduction Stroke is the largest cause of adult disability in England (Dept of Health, 2010). Impaired arm function is reported in up to 70% of stroke survivors (Nakayama et al., 1994). Only 12% regains complete functional recovery in the paretic upper limb (UL) (Kwakkel et al., 2003). Consequently, UL rehabilitation continues to be a major focus of occupational therapy intervention following stroke. Therapeutic interventions have focussed on highly repetitive training that is task specific and 108
goal directed (Classen et al., 1998; Teasell et al., 2007). However, repetitive task practice poses huge challenges for patients with substantial UL weakness. The SaeboFlex was developed in the United States by two occupational therapists and subsequently introduced in the UK. It is a custom fabricated, non-electrical, mechanical orthosis. It allows patients with a substantially weak UL, particularly those without active finger extension, to participate in repetitive task practice. It positions the wrist and fingers in extension in preparation for grasp and release. Occup. Ther. Int. 21 (2014) 108–114 © 2014 John Wiley & Sons, Ltd.
Stuck et al.
The user actively flexes their fingers to grasp; the extension spring system assists in opening the hand. There is weak evidence for effectiveness of SaeboFlex training in both chronic stroke (Farrell et al., 2007; Heise et al., 2010) and acute stroke (Davenport et al., 2011; Francka et al., 2013). It is well recognized that the greatest potential for brain recovery is within the first 3–6 months after stroke (Calautti and Baron, 2003; Biernaskie et al., 2004; Stein, 2004). There is a strong case to explore the use of SaeboFlex training in the early stages after stroke. This approach has several rationales: prevention of learned non-use, exploitation of the “golden period” to produce the best response to motor training and cost-effectiveness through self-directed training enabling higher intensity of therapy without the need for extra staffing. The aim of this feasibility study is to explore the possible benefits, implications, tolerance, patient’s experience and the usability of SaeboFlex training in acute stroke patients.
Method Ethical approval for this study was obtained. Patients with UL weakness were identified. The key inclusion criteria were anterior circulation stroke patients (3–84 days post-stroke); substantial paresis of the arm and hand, with at least 15° active elbow and shoulder movement in any plane and some active finger flexion, pre-morbid fully functional UL, and medically fit to participate in therapy. Our study aimed to evaluate SaeboFlex in acute and sub-acute stroke, and hence, we used a time frame of 12 weeks for the inclusion period. In patients with mild weakness, conventional rehabilitation alone may be sufficient, and hence, they were not included.
SaeboFlex intervention Patients participated in a 12-week individualized training programme, at a maximum intensity of 3 × 45 minutes a day. Therapists specified the duration and the intensity for the self-directed component of the intervention. Participants were reviewed at least once a week to monitor adverse effects and training programmes. SaeboFlex training was used in combination with routine therapy both in the hospital and at home. Training was both therapist led and self-directed. Training intensities were monitored through patient-completed training schedules. Occup. Ther. Int. 21 (2014) 108–114 © 2014 John Wiley & Sons, Ltd.
SaeboFlex Upper-limb Training
Outcome measures Primary outcome measures: • Action research arm test (ARAT) • UL Motricity Index (MI) Secondary outcome measures: • • • • • •
Motor Assessment Scale – UL Section (UL-MAS) Modified Barthel Index (MBI) Berg Balance Scale (BBS) Visual Analogue Scale (VAS) Stroke Impact Scale (SIS) End of study questionnaire
All measures were taken before and after the 12-week intervention period, with additional interim measures (ARAT, MI, BBS and MBI) taken at 4 and 8 weeks. Fig. 1 shows the study procedure. For ARAT, an improvement of 5.7 points was used as clinically significant score in chronic stroke studies (Van der Lee et al., 2001). For acute stroke, this may not be sensitive and Lang et al. (2008) suggest that an improvement of 12 points in the dominant hand and 17 points in the non-dominant hand may be appropriate in acute stroke. Although the individual minimal clinical important differences for the MI, UL-MAS and MBI have not been published, studies have suggested a change score of 10% in an outcome score as clinically relevant (Bronfort and Bouter, 1999; Hsieh et al., 2007). Thus, an improvement of 10 points could be considered clinically significant for MI and MBI and a score of 1.8 for UL-MAS. For BBS, clinically significant score varies according to baseline score. For baseline scores of 45–56, 35–44, 25–34 and 0–24, clinically significant change scores are considered to be four, five, seven and five, respectively (Donoghue and Stokes, 2009). For the SIS physical domains, improvements of 9.2, 5.9, 4.5 and 17.8 points on the four subscales (strength, activities, mobility and UL function) have been suggested as clinically important changes (Lin et al., 2010).
Results Subject characteristics Out of a total of eight participants, one participant (participant two) withdrew after 2 weeks because of unrelated medical complications, and the results have not been included in the analysis. Mean age was 70 years (standard deviation [SD] 15). Age ranged between 39 109
Stuck et al.
SaeboFlex Upper-limb Training
Subject identified by clinical therapist as meeting inclusion for SaeboFlex Orthosis
Information about SaeboFlex Training and Research given
Informed consent obtained
Table I. Baseline characteristics Participant identification
Stroke classification
Gender
Age (years)
Days post-stroke
1 2 3 4 5 6 7 8
Left PACS Right PACS Right TACS Right PACS Right PACS Left PACS Right LACS Left PACS
Male Male Male Female Female Male Female Female
59 82 69 68 39 82 79 83
16 40 30 13 24 7 12 45
PACS, partial anterior circulation stroke; TACS, total anterior circu-
Baseline measures taken
SaeboFlex measured and fitted by trained therapist Individual training programme developed Relatives/patient to put SaeboFlex on and off
lation stroke; LACS, lacunar stroke.
Participants were trained once or twice a day. The duration of training sessions varied greatly, ranging between 5 and 105 minutes per day. The number of grasp and release repetitions ranged between 12 and 500 per day. Questionnaires
12 weeks of SaeboFlex training Participants recorded daily participation in SaeboFlex Training
Interim measures at 4 and 8 weeks
Results of questionnaires revealed that six out of seven participants felt that the SaeboFlex was easy to don and doff, but one participant found it difficult to fit the caps on his fingers due to increased tone. All participants felt that the SaeboFlex training has improved their UL outcomes.
Discussion Outcome Measures at 12 weeks
Figure 1. Research process flowchart
and 83 years. Baseline characteristics are listed in Table I. Participants were recruited after a mean of 21 (SD 13.1) days post-stroke. All participants had substantial weakness with an ARAT score of ≤24 points (mean score 10 [SD 8.2]).
Effects of SaeboFlex training Table II shows the summary of primary and secondary outcomes. Tables III and IV describe individual scores for various outcomes (ARAT, UL MI, MBI, BBS, ULMAS, VAS and SIS [four physical domains]). The average duration of training at various interim periods is shown in Table V. No participant was trained at the maximum recommended intensity of 3 × 45 minutes a day. 110
This study is one of the first studies to use the SaeboFlex in acute/sub-acute stroke. We have demonstrated that SaeboFlex training is feasible in patients with substantial UL weakness both as an inpatient and in the community. With the exception of one participant (participant 4), all achieved clinically significant improvements in primary outcome measures and most other parameters. There was a wide range in the age group of participants, and in this small sample, it is not appropriate to draw conclusions on the relationship between patient’s age and the improvements in outcomes. As this study has no control group, we urge caution in interpreting the results. It is important to acknowledge that all were receiving conventional rehabilitation, and this along with spontaneous recovery could have contributed to or solely resulted in the positive outcomes. However, these positive results cannot be ignored as it is well documented that UL outcomes following stroke are poor (Kwakkel et al., 2003). Francka et al. (2013) investigated the usability and the effects of a dynamic spring-loaded orthosis Occup. Ther. Int. 21 (2014) 108–114 © 2014 John Wiley & Sons, Ltd.
Stuck et al.
SaeboFlex Upper-limb Training
Table II. Effect of the SaeboFlex on primary and secondary outcomes Measure
Baseline mean
ARAT UL Motricity Index Modified Barthel Berg balance UL-MAS VAS SIS (four physical domains)
10.0 (SD 54.3 (SD 62.0 (SD 22.9 (SD 4.1 (SD 2.6 (SD 72.8 (SD
12-week outcome mean
8.2) 16.1) 28.1) 21.2) 2.8) 1.9) 20.1)
37.6 76.1 88.3 48.0 10.6 6.3 101.7
(SD (SD (SD (SD (SD (SD (SD
Mean difference
21.1) 17.8) 14.1) 8.9) 6.7) 3.3) 28.1)
Number of patients achieving MCID
27.6 21.9 26.3 25.1 6.4 3.7 28.8
Six out of seven Six out of seven Five out of seven Six out of seven Five out of seven N/A One out of six
MCID, minimal clinical important differences; ARAT, action research arm test; UL, upper limb; UL-MAS, Motor Assessment Scale – UL Section; VAS, Visual Analogue Scale; SIS, Stroke Impact Scale.
Table III. Primary outcomes
Patient identification 1 3 4 5 6 7 8
ARAT
MI
Baseline
4 weeks
8 weeks
12 weeks
Baseline
4 weeks
8 weeks
12 weeks
24 3 4 7 3 18 11
46 3 17 42 9 57 32
49 8 20 54 13 57 37
54 14 12a 57 20 57 49
73 29 53 56 40 73 56
77 40 61 77 48 100 60
77 51 51 76 56 100 66
86 55 55a 92 67 100 78
ARAT, action research arm test; MI, Motricity Index. a
Clinically not significant.
Table IV. Secondary outcomes UL-MAS Patient identification
Baseline
1 3 4 5 6 7 8
7 1 7 4 0 6 4
Barthel
12 weeks 17 1a 3a 17 8 16 12
Baseline
Berg
12 weeks
98 53 98 48 28 72 37
a
100 80 97a 97 63 100 81
VAS
SIS
Baseline
12 weeks
Baseline
12 weeks
Baseline
12 weeks
24 16 55 4 9 49 3
54 41 55a 55 39 56 36
3 1 4 1 1 6 2
9 2 4 10 3 9 7
100 59 96 58 55 69
127a 68a 97a 133 70a 115a
b
b
a
Clinically not significant.
b
Patient refused.
along with usual therapy on functional use of the impaired hand in eight moderately/severely impaired sub-acute stroke patients. This study reported improvements on ARAT scores supporting the improvements we noted on ARAT scores in our study. All participants needed some 1 : 1 therapy time initially to teach donning/doffing and ensure use of appropriate technique and effective exercise regimes. It is important to highlight that some participants with Occup. Ther. Int. 21 (2014) 108–114 © 2014 John Wiley & Sons, Ltd.
significant weakness were independent in SaeboFlex training. However, not all patients were able to perform self-directed training initially.
Intensity of training Despite participants not training at the maximum 3 × 45 minutes of daily therapy, our results show that SaeboFlex training for lesser duration still resulted in 111
Stuck et al.
SaeboFlex Upper-limb Training
Table V. Duration of training and number of repetitions at different periods 0–4 weeks Patient identification 1 3 4 5 6 7 8
4–8 weeks
8–12 weeks
Mean duration of daily training (minutes)
Mean daily repetitions
Mean duration of daily training (minutes)
Mean daily repetitions
Mean duration of daily training (minutes)
Mean daily repetitions
25 15 30 11 23 4 18
209 21 62 46 43 15 58
19 14 16 6 28 3 11
173 26 48 51 76 5 35
N/A 59 9 N/A 51 N/A 20
125 136 7 0 178 2 49
clinically significant improvements. Although the average daily training time was 20 minutes per day, two participants trained consistently for more than 45 minutes a day over a 4-week period. Average duration of training was influenced by many factors such as participants not training for all days in a week and medical instability, and hence, too much importance should not be given to average intensity. Furthermore, participants attributed time factor, fatigue, reduced motivation, lack of family support and boredom as some of the reasons for not participating at recommended intensity levels. Some patients were able to participate in other therapies and hence reduced the training intensity with SaeboFlex. It needs to be highlighted that training with the SaeboFlex orthosis could have enabled the participants with significant weakness to achieve a greater number of reach to grasp repetitions than one would expect through conventional therapies. For example, in our case series, some patients had very low ARAT scores, and these patients would not have been in a position to participate in functional repetitive task practice without the assistance of SaeboFlex or a therapist. However, this would need to be evaluated further in a controlled trial. SaeboFlex training needs to be carefully prescribed and reviewed to ensure it remains challenging, motivational and structured into patient’s daily routine to achieve greater intensity. The optimum dosage remains unclear and needs further research.
SIS do not necessarily mirror these findings nor do they reflect improvements seen in objective or functional measures such as ARAT, MI or MBI. Results for SIS showed generally positive trends but were not clinically significant. However, it is important to bear in mind that baseline SIS was completed during the inpatient stay whilst 12-week SIS was performed at home. Unexpected difficulties experienced at home when compared with baseline at hospital may be a plausible explanation.
Adverse events One participant experienced shoulder complications in this study. Shoulder complications are common after a stroke, and it is not known whether such shoulder complications could be exacerbated by SaeboFlex training Concerns have been raised in previous trials regarding safety of highly intensive training in the early phase of acute stroke (Cramer, 2009). Although SaeboFlex training in this study was not as intensive as 6 hours a day of constraint-induced movement therapy (CIMT) as practised in the very early constraint-induced movement during stroke rehabilitation study (Dromerick et al., 2000), we found no evidence one way or the other for such concerns related to intensive SaeboFlex training in acute stroke. Implications for clinical practice
Participant perspectives All participants reported that SaeboFlex training had improved their UL function. This was further supported by self-perceived improvements in VAS scores in most patients. In contrast, results from the 112
Given the poor outcomes in UL recovery post-stroke, the improvements noted with SaeboFlex training require further evaluation to determine its clinical utility. SaeboFlex training has the potential to improve patients UL function and potentially improve Occup. Ther. Int. 21 (2014) 108–114 © 2014 John Wiley & Sons, Ltd.
Stuck et al.
participation and independence in ADLs, reduce carer burden and associated costs and facilitate return to activities such as driving or work. This has significant implications for the discipline of occupational therapy. Besides facilitating functional improvements of the UL, SaeboFlex may enhance usage of weak UL for participation in other therapies such as CIMT and functional strength training. In patients with severe weakness, most active UL rehabilitation techniques require 1 : 1 therapy, but this requirement may be reduced once participants are successful with self-directed SaeboFlex training. This is potentially cost-effective. Furthermore, group work with SaeboFlex could be easily implemented with less rehabilitation staff when compared with other rehabilitation modalities. SaeboFlex empowers self-directed training. It can also be performed simultaneously along with training of the lower limb and trunk to improve other impairments. It is important to invest in training and education of patients and their next of kin to increase motivation, confidence and ability to continue selfdirected training and thereby maximizing intensity.
Limitations This study suffers from all the weaknesses one would expect from a non-controlled study. As this was designed to be a feasibility study, the numbers are small, and hence, we urge caution in interpreting these results. Therapists who performed outcome measures were not blinded. Nevertheless, standardized protocols were followed, and therapists were given training to improve the accuracy and reliability of administration and scoring.
Future research This study has raised the possibility that SaeboFlex training could evolve as an option for acute/sub-acute stroke patients with substantial weakness. It is important to explore in a large-scale randomized controlled trial whether SaeboFlex training results in recovery of UL function and has impact on length of stay and dependency levels. It may also be beneficial to know which patient groups would benefit the most and the optimum dosage and frequency of SaeboFlex training. Further research is needed to answer these questions, and a randomized controlled study in acute/sub-acute stroke is needed. Occup. Ther. Int. 21 (2014) 108–114 © 2014 John Wiley & Sons, Ltd.
SaeboFlex Upper-limb Training
Conclusion SaeboFlex training is feasible in acute stroke patients and has the potential to augment functional recovery and participation in conventional therapy in a selected cohort of acute stroke patients with moderate to severe impairments of the UL. Further research is needed on SaeboFlex training in acute stroke with a control arm at various dosing to evaluate its efficacy and determine the optimum intensity of intervention.
Conflict of interest The authors declare no conflict of interest.
Acknowledgement The authors would like to acknowledge the Colchester Hospital University Foundation NHS Trust for the support of this study. REFERENCES Biernaskie J, Chernenko G, Corbett D (2004). Efficacy of rehabilitative experience declines with time after focal ischemic brain injury. Journal of Neuroscience 24: 1245–1254. Bronfort G, Bouter LM (1999). Responsiveness of general health status in low back pain: a comparison of the COOP charts and SF-36. Pain 83: 201–209. Calautti C, Baron JC (2003). Functional neuroimaging studies of motor recovery after stroke in adults: a review. Stroke 34: 1553–1566. Classen J, Liepert J, Wise SP, Hallett M, Cohen LG (1998). Rapid plasticity of human cortical movement representation induced by practice. Journal of Neurophysiology 79(2): 1117–1123. Cramer S (2009). The VECTORS study: when too much of a good thing is harmful. Neurology 73: 170–171. Davenport S, Brogden S, Cairns M (2011). The role of the SaeboFlex within therapy for patients with acute/sub-acute stroke – a proof of concept study. WCPT, Amsterdam (platform presentation). Department of Health: Progress in improving stroke care. National Audit Office (2010). http://www.nao.org.uk/ report/department-of-health-progress-in-improvingstroke-care/ [26 September 2013] Donoghue D, Stokes EK (2009). How much change is true change? The minimum detectable change of the Berg Balance Scale in elderly people. Journal of Rehabilitation Medicine 41: 343–346. Dromerick AW, Lang CE, Birkenmeier RL, Wagner JM, Miller JP, Videen TO, Powers WJ, Wolf SL, Edwards DF (2000). Very early constraint induced movement during 113
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stroke rehabilitation (VECTORS) a single-center RCT. Neurology 73(3): 195–201. Farrell JF, Hoffman HB, Snyder JL, Giuliani CA, Bohannon RW (2007). Orthotic aided training of the paretic upper limb in chronic stroke: results of a phase 1 trial. NeuroRehabilitation 22(2): 99–103. Francka JA, Timmermans AAA, Seelen HAM (2013). Effects of a dynamic hand orthosis for functional use of the impaired upper limb in sub-acute stroke patients: a multiple single case experimental design study. Technology and Disability 25: 177–187. Hsieh YW, Wang CH, Wu SC, Chen PC, Sheu CF, Hsieh CL (2007). Establishing the minimal clinically important difference of the Barthel Index in stroke patients. Neurorehabilitation and Neural Repair 21: 233–238. Heise KF, Liuzzi G, Zimerman M, Gerloff C, Hummel F (2010). Intensive orthosis-based home training of the upper limb leads to pronounced improvements in patients in the chronic stage after brain lesions. WCNR Vienna, A165, http://www.saebo.com/ therapists/pdf/kheise_wcnr2010%20saebo.pdf (accessed on 11 November 2010) Kwakkel G, Kollen BJ, Grond J, Prevo AJH (2003). Probability of regaining dexterity in the flaccid upper limb:
114
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impact of severity of paresis and time since onset in acute stroke. Stroke 34: 2181–2186. Lang CE, Edwards DF, Birkenmeier RL, Dromerick AW (2008). Estimating minimal clinically important differences of upper extremity measures early after stroke. Archives of Physical Medicine and Rehabilitation 89(9): 1693. Lin KC, Fu T, Wu CY, Wang YH, Liu JS, Hsieh CJ, Lin SF (2010). Minimal detectable change and clinically important difference of the Stroke Impact Scale in stroke patients. Neurorehabilitation and Neural Repair 24(5): 486–492. Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS (1994). Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Archives of Physical Medicine and Rehabilitation 75: 394–398. Stein J (2004). Motor recovery strategies after stroke. Top Stroke Rehabilitation 11: 12–22. Teasell R, Foley N, Salter K, Sanjit B, Jutai J, Speechley M (2007). Evidence based review of stroke rehabilitation. Topics in Stroke Rehabilitation 19(1): 29–58. Van der Lee JH, De Groot V, Beckerman H, Wagenaar RC, Lankhorst GJ, Bouter LM (2001). The intra- and interrater reliability of the action research arm test: a practical test of upper extremity function in patients with stroke. Archives of Physical Medicine and Rehabilitation 82(1): 14–19.
Occup. Ther. Int. 21 (2014) 108–114 © 2014 John Wiley & Sons, Ltd.
Feasibility of SaeboFlex Upper-limb Training in Acute Stroke Rehabilitation: A Clinical Case Series‡ Rebecca A. Stuck, Lisa M. Marshall*† & Ramachandran Sivakumar Division of Stroke Medicine, Colchester Hospital University Foundation NHS Trust, Colchester, UK
Abstract Upper-limb (UL) recovery following stroke is often poor. UL rehabilitation therefore continues to be a major focus for occupational therapy. Published evidence for the effectiveness of SaeboFlex training in acute stroke rehabilitation is scarce. The purpose of this study is to explore the feasibility and patient experience of SaeboFlex training in acute stroke. This feasibility study recruited stroke patients (< 84 days post-stroke) with moderate/severe UL weakness. They participated in SaeboFlex sessions for 12 weeks in addition to conventional rehabilitation. A battery of measures was taken at baseline, 4, 8 and 12 weeks. Eight participants were recruited. For the action research arm test score and UL Motricity Index, clinically significant improvements were noted in five out of seven (71%) and six out of seven participants (86%) respectively. Clinically significant improvements were also noted in secondary outcomes. Shoulder complications occurred in one participant. SaeboFlex training facilitated clinically significant improvements in UL function. It has the potential to improve participation and independence in ADLs, reduce carer burden and associated costs. Being a feasibility study with no control arm, we urge caution in interpreting these results. Future research is needed to evaluate the efficacy, optimum dosage and impact on dependency levels of SaeboFlex training as part of a randomized controlled trial Copyright © 2014 John Wiley & Sons, Ltd. Received 30 September 2013; Revised 11 February 2014; Accepted 6 March 2014
Keywords SaeboFlex; upper limb; stroke rehabilitation *Correspondence Lisa Marshall, Stroke Unit, Colchester Hospital University Foundation NHS Trust, Turner Road, Colchester, Essex, CO4 5JL, UK. †
Email: [email protected]
‡
Ethics Reference number: 11/H0302/8
Published online 24 April 2014 in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/oti.1369
Introduction Stroke is the largest cause of adult disability in England (Dept of Health, 2010). Impaired arm function is reported in up to 70% of stroke survivors (Nakayama et al., 1994). Only 12% regains complete functional recovery in the paretic upper limb (UL) (Kwakkel et al., 2003). Consequently, UL rehabilitation continues to be a major focus of occupational therapy intervention following stroke. Therapeutic interventions have focussed on highly repetitive training that is task specific and 108
goal directed (Classen et al., 1998; Teasell et al., 2007). However, repetitive task practice poses huge challenges for patients with substantial UL weakness. The SaeboFlex was developed in the United States by two occupational therapists and subsequently introduced in the UK. It is a custom fabricated, non-electrical, mechanical orthosis. It allows patients with a substantially weak UL, particularly those without active finger extension, to participate in repetitive task practice. It positions the wrist and fingers in extension in preparation for grasp and release. Occup. Ther. Int. 21 (2014) 108–114 © 2014 John Wiley & Sons, Ltd.
Stuck et al.
The user actively flexes their fingers to grasp; the extension spring system assists in opening the hand. There is weak evidence for effectiveness of SaeboFlex training in both chronic stroke (Farrell et al., 2007; Heise et al., 2010) and acute stroke (Davenport et al., 2011; Francka et al., 2013). It is well recognized that the greatest potential for brain recovery is within the first 3–6 months after stroke (Calautti and Baron, 2003; Biernaskie et al., 2004; Stein, 2004). There is a strong case to explore the use of SaeboFlex training in the early stages after stroke. This approach has several rationales: prevention of learned non-use, exploitation of the “golden period” to produce the best response to motor training and cost-effectiveness through self-directed training enabling higher intensity of therapy without the need for extra staffing. The aim of this feasibility study is to explore the possible benefits, implications, tolerance, patient’s experience and the usability of SaeboFlex training in acute stroke patients.
Method Ethical approval for this study was obtained. Patients with UL weakness were identified. The key inclusion criteria were anterior circulation stroke patients (3–84 days post-stroke); substantial paresis of the arm and hand, with at least 15° active elbow and shoulder movement in any plane and some active finger flexion, pre-morbid fully functional UL, and medically fit to participate in therapy. Our study aimed to evaluate SaeboFlex in acute and sub-acute stroke, and hence, we used a time frame of 12 weeks for the inclusion period. In patients with mild weakness, conventional rehabilitation alone may be sufficient, and hence, they were not included.
SaeboFlex intervention Patients participated in a 12-week individualized training programme, at a maximum intensity of 3 × 45 minutes a day. Therapists specified the duration and the intensity for the self-directed component of the intervention. Participants were reviewed at least once a week to monitor adverse effects and training programmes. SaeboFlex training was used in combination with routine therapy both in the hospital and at home. Training was both therapist led and self-directed. Training intensities were monitored through patient-completed training schedules. Occup. Ther. Int. 21 (2014) 108–114 © 2014 John Wiley & Sons, Ltd.
SaeboFlex Upper-limb Training
Outcome measures Primary outcome measures: • Action research arm test (ARAT) • UL Motricity Index (MI) Secondary outcome measures: • • • • • •
Motor Assessment Scale – UL Section (UL-MAS) Modified Barthel Index (MBI) Berg Balance Scale (BBS) Visual Analogue Scale (VAS) Stroke Impact Scale (SIS) End of study questionnaire
All measures were taken before and after the 12-week intervention period, with additional interim measures (ARAT, MI, BBS and MBI) taken at 4 and 8 weeks. Fig. 1 shows the study procedure. For ARAT, an improvement of 5.7 points was used as clinically significant score in chronic stroke studies (Van der Lee et al., 2001). For acute stroke, this may not be sensitive and Lang et al. (2008) suggest that an improvement of 12 points in the dominant hand and 17 points in the non-dominant hand may be appropriate in acute stroke. Although the individual minimal clinical important differences for the MI, UL-MAS and MBI have not been published, studies have suggested a change score of 10% in an outcome score as clinically relevant (Bronfort and Bouter, 1999; Hsieh et al., 2007). Thus, an improvement of 10 points could be considered clinically significant for MI and MBI and a score of 1.8 for UL-MAS. For BBS, clinically significant score varies according to baseline score. For baseline scores of 45–56, 35–44, 25–34 and 0–24, clinically significant change scores are considered to be four, five, seven and five, respectively (Donoghue and Stokes, 2009). For the SIS physical domains, improvements of 9.2, 5.9, 4.5 and 17.8 points on the four subscales (strength, activities, mobility and UL function) have been suggested as clinically important changes (Lin et al., 2010).
Results Subject characteristics Out of a total of eight participants, one participant (participant two) withdrew after 2 weeks because of unrelated medical complications, and the results have not been included in the analysis. Mean age was 70 years (standard deviation [SD] 15). Age ranged between 39 109
Stuck et al.
SaeboFlex Upper-limb Training
Subject identified by clinical therapist as meeting inclusion for SaeboFlex Orthosis
Information about SaeboFlex Training and Research given
Informed consent obtained
Table I. Baseline characteristics Participant identification
Stroke classification
Gender
Age (years)
Days post-stroke
1 2 3 4 5 6 7 8
Left PACS Right PACS Right TACS Right PACS Right PACS Left PACS Right LACS Left PACS
Male Male Male Female Female Male Female Female
59 82 69 68 39 82 79 83
16 40 30 13 24 7 12 45
PACS, partial anterior circulation stroke; TACS, total anterior circu-
Baseline measures taken
SaeboFlex measured and fitted by trained therapist Individual training programme developed Relatives/patient to put SaeboFlex on and off
lation stroke; LACS, lacunar stroke.
Participants were trained once or twice a day. The duration of training sessions varied greatly, ranging between 5 and 105 minutes per day. The number of grasp and release repetitions ranged between 12 and 500 per day. Questionnaires
12 weeks of SaeboFlex training Participants recorded daily participation in SaeboFlex Training
Interim measures at 4 and 8 weeks
Results of questionnaires revealed that six out of seven participants felt that the SaeboFlex was easy to don and doff, but one participant found it difficult to fit the caps on his fingers due to increased tone. All participants felt that the SaeboFlex training has improved their UL outcomes.
Discussion Outcome Measures at 12 weeks
Figure 1. Research process flowchart
and 83 years. Baseline characteristics are listed in Table I. Participants were recruited after a mean of 21 (SD 13.1) days post-stroke. All participants had substantial weakness with an ARAT score of ≤24 points (mean score 10 [SD 8.2]).
Effects of SaeboFlex training Table II shows the summary of primary and secondary outcomes. Tables III and IV describe individual scores for various outcomes (ARAT, UL MI, MBI, BBS, ULMAS, VAS and SIS [four physical domains]). The average duration of training at various interim periods is shown in Table V. No participant was trained at the maximum recommended intensity of 3 × 45 minutes a day. 110
This study is one of the first studies to use the SaeboFlex in acute/sub-acute stroke. We have demonstrated that SaeboFlex training is feasible in patients with substantial UL weakness both as an inpatient and in the community. With the exception of one participant (participant 4), all achieved clinically significant improvements in primary outcome measures and most other parameters. There was a wide range in the age group of participants, and in this small sample, it is not appropriate to draw conclusions on the relationship between patient’s age and the improvements in outcomes. As this study has no control group, we urge caution in interpreting the results. It is important to acknowledge that all were receiving conventional rehabilitation, and this along with spontaneous recovery could have contributed to or solely resulted in the positive outcomes. However, these positive results cannot be ignored as it is well documented that UL outcomes following stroke are poor (Kwakkel et al., 2003). Francka et al. (2013) investigated the usability and the effects of a dynamic spring-loaded orthosis Occup. Ther. Int. 21 (2014) 108–114 © 2014 John Wiley & Sons, Ltd.
Stuck et al.
SaeboFlex Upper-limb Training
Table II. Effect of the SaeboFlex on primary and secondary outcomes Measure
Baseline mean
ARAT UL Motricity Index Modified Barthel Berg balance UL-MAS VAS SIS (four physical domains)
10.0 (SD 54.3 (SD 62.0 (SD 22.9 (SD 4.1 (SD 2.6 (SD 72.8 (SD
12-week outcome mean
8.2) 16.1) 28.1) 21.2) 2.8) 1.9) 20.1)
37.6 76.1 88.3 48.0 10.6 6.3 101.7
(SD (SD (SD (SD (SD (SD (SD
Mean difference
21.1) 17.8) 14.1) 8.9) 6.7) 3.3) 28.1)
Number of patients achieving MCID
27.6 21.9 26.3 25.1 6.4 3.7 28.8
Six out of seven Six out of seven Five out of seven Six out of seven Five out of seven N/A One out of six
MCID, minimal clinical important differences; ARAT, action research arm test; UL, upper limb; UL-MAS, Motor Assessment Scale – UL Section; VAS, Visual Analogue Scale; SIS, Stroke Impact Scale.
Table III. Primary outcomes
Patient identification 1 3 4 5 6 7 8
ARAT
MI
Baseline
4 weeks
8 weeks
12 weeks
Baseline
4 weeks
8 weeks
12 weeks
24 3 4 7 3 18 11
46 3 17 42 9 57 32
49 8 20 54 13 57 37
54 14 12a 57 20 57 49
73 29 53 56 40 73 56
77 40 61 77 48 100 60
77 51 51 76 56 100 66
86 55 55a 92 67 100 78
ARAT, action research arm test; MI, Motricity Index. a
Clinically not significant.
Table IV. Secondary outcomes UL-MAS Patient identification
Baseline
1 3 4 5 6 7 8
7 1 7 4 0 6 4
Barthel
12 weeks 17 1a 3a 17 8 16 12
Baseline
Berg
12 weeks
98 53 98 48 28 72 37
a
100 80 97a 97 63 100 81
VAS
SIS
Baseline
12 weeks
Baseline
12 weeks
Baseline
12 weeks
24 16 55 4 9 49 3
54 41 55a 55 39 56 36
3 1 4 1 1 6 2
9 2 4 10 3 9 7
100 59 96 58 55 69
127a 68a 97a 133 70a 115a
b
b
a
Clinically not significant.
b
Patient refused.
along with usual therapy on functional use of the impaired hand in eight moderately/severely impaired sub-acute stroke patients. This study reported improvements on ARAT scores supporting the improvements we noted on ARAT scores in our study. All participants needed some 1 : 1 therapy time initially to teach donning/doffing and ensure use of appropriate technique and effective exercise regimes. It is important to highlight that some participants with Occup. Ther. Int. 21 (2014) 108–114 © 2014 John Wiley & Sons, Ltd.
significant weakness were independent in SaeboFlex training. However, not all patients were able to perform self-directed training initially.
Intensity of training Despite participants not training at the maximum 3 × 45 minutes of daily therapy, our results show that SaeboFlex training for lesser duration still resulted in 111
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Table V. Duration of training and number of repetitions at different periods 0–4 weeks Patient identification 1 3 4 5 6 7 8
4–8 weeks
8–12 weeks
Mean duration of daily training (minutes)
Mean daily repetitions
Mean duration of daily training (minutes)
Mean daily repetitions
Mean duration of daily training (minutes)
Mean daily repetitions
25 15 30 11 23 4 18
209 21 62 46 43 15 58
19 14 16 6 28 3 11
173 26 48 51 76 5 35
N/A 59 9 N/A 51 N/A 20
125 136 7 0 178 2 49
clinically significant improvements. Although the average daily training time was 20 minutes per day, two participants trained consistently for more than 45 minutes a day over a 4-week period. Average duration of training was influenced by many factors such as participants not training for all days in a week and medical instability, and hence, too much importance should not be given to average intensity. Furthermore, participants attributed time factor, fatigue, reduced motivation, lack of family support and boredom as some of the reasons for not participating at recommended intensity levels. Some patients were able to participate in other therapies and hence reduced the training intensity with SaeboFlex. It needs to be highlighted that training with the SaeboFlex orthosis could have enabled the participants with significant weakness to achieve a greater number of reach to grasp repetitions than one would expect through conventional therapies. For example, in our case series, some patients had very low ARAT scores, and these patients would not have been in a position to participate in functional repetitive task practice without the assistance of SaeboFlex or a therapist. However, this would need to be evaluated further in a controlled trial. SaeboFlex training needs to be carefully prescribed and reviewed to ensure it remains challenging, motivational and structured into patient’s daily routine to achieve greater intensity. The optimum dosage remains unclear and needs further research.
SIS do not necessarily mirror these findings nor do they reflect improvements seen in objective or functional measures such as ARAT, MI or MBI. Results for SIS showed generally positive trends but were not clinically significant. However, it is important to bear in mind that baseline SIS was completed during the inpatient stay whilst 12-week SIS was performed at home. Unexpected difficulties experienced at home when compared with baseline at hospital may be a plausible explanation.
Adverse events One participant experienced shoulder complications in this study. Shoulder complications are common after a stroke, and it is not known whether such shoulder complications could be exacerbated by SaeboFlex training Concerns have been raised in previous trials regarding safety of highly intensive training in the early phase of acute stroke (Cramer, 2009). Although SaeboFlex training in this study was not as intensive as 6 hours a day of constraint-induced movement therapy (CIMT) as practised in the very early constraint-induced movement during stroke rehabilitation study (Dromerick et al., 2000), we found no evidence one way or the other for such concerns related to intensive SaeboFlex training in acute stroke. Implications for clinical practice
Participant perspectives All participants reported that SaeboFlex training had improved their UL function. This was further supported by self-perceived improvements in VAS scores in most patients. In contrast, results from the 112
Given the poor outcomes in UL recovery post-stroke, the improvements noted with SaeboFlex training require further evaluation to determine its clinical utility. SaeboFlex training has the potential to improve patients UL function and potentially improve Occup. Ther. Int. 21 (2014) 108–114 © 2014 John Wiley & Sons, Ltd.
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participation and independence in ADLs, reduce carer burden and associated costs and facilitate return to activities such as driving or work. This has significant implications for the discipline of occupational therapy. Besides facilitating functional improvements of the UL, SaeboFlex may enhance usage of weak UL for participation in other therapies such as CIMT and functional strength training. In patients with severe weakness, most active UL rehabilitation techniques require 1 : 1 therapy, but this requirement may be reduced once participants are successful with self-directed SaeboFlex training. This is potentially cost-effective. Furthermore, group work with SaeboFlex could be easily implemented with less rehabilitation staff when compared with other rehabilitation modalities. SaeboFlex empowers self-directed training. It can also be performed simultaneously along with training of the lower limb and trunk to improve other impairments. It is important to invest in training and education of patients and their next of kin to increase motivation, confidence and ability to continue selfdirected training and thereby maximizing intensity.
Limitations This study suffers from all the weaknesses one would expect from a non-controlled study. As this was designed to be a feasibility study, the numbers are small, and hence, we urge caution in interpreting these results. Therapists who performed outcome measures were not blinded. Nevertheless, standardized protocols were followed, and therapists were given training to improve the accuracy and reliability of administration and scoring.
Future research This study has raised the possibility that SaeboFlex training could evolve as an option for acute/sub-acute stroke patients with substantial weakness. It is important to explore in a large-scale randomized controlled trial whether SaeboFlex training results in recovery of UL function and has impact on length of stay and dependency levels. It may also be beneficial to know which patient groups would benefit the most and the optimum dosage and frequency of SaeboFlex training. Further research is needed to answer these questions, and a randomized controlled study in acute/sub-acute stroke is needed. Occup. Ther. Int. 21 (2014) 108–114 © 2014 John Wiley & Sons, Ltd.
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Conclusion SaeboFlex training is feasible in acute stroke patients and has the potential to augment functional recovery and participation in conventional therapy in a selected cohort of acute stroke patients with moderate to severe impairments of the UL. Further research is needed on SaeboFlex training in acute stroke with a control arm at various dosing to evaluate its efficacy and determine the optimum intensity of intervention.
Conflict of interest The authors declare no conflict of interest.
Acknowledgement The authors would like to acknowledge the Colchester Hospital University Foundation NHS Trust for the support of this study. REFERENCES Biernaskie J, Chernenko G, Corbett D (2004). Efficacy of rehabilitative experience declines with time after focal ischemic brain injury. Journal of Neuroscience 24: 1245–1254. Bronfort G, Bouter LM (1999). Responsiveness of general health status in low back pain: a comparison of the COOP charts and SF-36. Pain 83: 201–209. Calautti C, Baron JC (2003). Functional neuroimaging studies of motor recovery after stroke in adults: a review. Stroke 34: 1553–1566. Classen J, Liepert J, Wise SP, Hallett M, Cohen LG (1998). Rapid plasticity of human cortical movement representation induced by practice. Journal of Neurophysiology 79(2): 1117–1123. Cramer S (2009). The VECTORS study: when too much of a good thing is harmful. Neurology 73: 170–171. Davenport S, Brogden S, Cairns M (2011). The role of the SaeboFlex within therapy for patients with acute/sub-acute stroke – a proof of concept study. WCPT, Amsterdam (platform presentation). Department of Health: Progress in improving stroke care. National Audit Office (2010). http://www.nao.org.uk/ report/department-of-health-progress-in-improvingstroke-care/ [26 September 2013] Donoghue D, Stokes EK (2009). How much change is true change? The minimum detectable change of the Berg Balance Scale in elderly people. Journal of Rehabilitation Medicine 41: 343–346. Dromerick AW, Lang CE, Birkenmeier RL, Wagner JM, Miller JP, Videen TO, Powers WJ, Wolf SL, Edwards DF (2000). Very early constraint induced movement during 113
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stroke rehabilitation (VECTORS) a single-center RCT. Neurology 73(3): 195–201. Farrell JF, Hoffman HB, Snyder JL, Giuliani CA, Bohannon RW (2007). Orthotic aided training of the paretic upper limb in chronic stroke: results of a phase 1 trial. NeuroRehabilitation 22(2): 99–103. Francka JA, Timmermans AAA, Seelen HAM (2013). Effects of a dynamic hand orthosis for functional use of the impaired upper limb in sub-acute stroke patients: a multiple single case experimental design study. Technology and Disability 25: 177–187. Hsieh YW, Wang CH, Wu SC, Chen PC, Sheu CF, Hsieh CL (2007). Establishing the minimal clinically important difference of the Barthel Index in stroke patients. Neurorehabilitation and Neural Repair 21: 233–238. Heise KF, Liuzzi G, Zimerman M, Gerloff C, Hummel F (2010). Intensive orthosis-based home training of the upper limb leads to pronounced improvements in patients in the chronic stage after brain lesions. WCNR Vienna, A165, http://www.saebo.com/ therapists/pdf/kheise_wcnr2010%20saebo.pdf (accessed on 11 November 2010) Kwakkel G, Kollen BJ, Grond J, Prevo AJH (2003). Probability of regaining dexterity in the flaccid upper limb:
114
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impact of severity of paresis and time since onset in acute stroke. Stroke 34: 2181–2186. Lang CE, Edwards DF, Birkenmeier RL, Dromerick AW (2008). Estimating minimal clinically important differences of upper extremity measures early after stroke. Archives of Physical Medicine and Rehabilitation 89(9): 1693. Lin KC, Fu T, Wu CY, Wang YH, Liu JS, Hsieh CJ, Lin SF (2010). Minimal detectable change and clinically important difference of the Stroke Impact Scale in stroke patients. Neurorehabilitation and Neural Repair 24(5): 486–492. Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS (1994). Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Archives of Physical Medicine and Rehabilitation 75: 394–398. Stein J (2004). Motor recovery strategies after stroke. Top Stroke Rehabilitation 11: 12–22. Teasell R, Foley N, Salter K, Sanjit B, Jutai J, Speechley M (2007). Evidence based review of stroke rehabilitation. Topics in Stroke Rehabilitation 19(1): 29–58. Van der Lee JH, De Groot V, Beckerman H, Wagenaar RC, Lankhorst GJ, Bouter LM (2001). The intra- and interrater reliability of the action research arm test: a practical test of upper extremity function in patients with stroke. Archives of Physical Medicine and Rehabilitation 82(1): 14–19.
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