538068

research-article2014

CRE0010.1177/0269215514538068Clinical RehabilitationSenthilvelkumar et al.

CLINICAL REHABILITATION

Article

Comparison of body weightsupported treadmill training versus body weight-supported overground training in people with incomplete tetraplegia: a pilot randomized trial

Clinical Rehabilitation 2015, Vol. 29(1) 42­–49 © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0269215514538068 cre.sagepub.com

Thangavelu Senthilvelkumar1, Henry Magimairaj2, Jebaraj Fletcher1, George Tharion2 and Jacob George2

Abstract Objective: To compare the effectiveness of body weight-supported treadmill training and body weightsupported overground training for improving gait and strength in people with traumatic incomplete tetraplegia. Design: Assessor blinded randomized trial. Setting: Rehabilitation institute of a tertiary care teaching hospital in India. Participants: Sixteen participants with traumatic motor incomplete tetraplegia and within two years of injury. Interventions: Participants were randomised to one of two groups: body weight-supported overground training on level ground and body weight-supported treadmill training. Both groups received 30 minutes of gait training per day, five days a week for eight weeks. In addition, both groups received regular rehabilitation which included flexibility, strength, balance, self care and functional training. Outcome measures: The primary outcome measure was the Walking Index for Spinal Cord Injury (/20 points) and the secondary outcome was the Lower Extremity Muscle Score (/50 points). Results: There was no statistically significant between group differences in the Walking Index for Spinal Cord Injury [mean difference=0.3points; 95% CI (-4.8 to 5.4); p=0.748] or the Lower Extremity Muscle Score [mean difference=0.2 points; 95% CI (-3.8 to 5.1); p=0.749]. Conclusions: Gait training with body weight-supported overground training is comparable to treadmill training for improving locomotion in people with traumatic incomplete tetraplegia. Keywords Spinal cord injuries, locomotion, body weight-supported Received: 5 November 2013; accepted: 11 May 2014

1P hysical

Therapy Unit, Rehabilitation Institute, Department of Physical Medicine and Rehabilitation, Christian Medical College, Tamil Nadu, India 2Department of Physical Medicine and Rehabilitation, Christian Medical College, Tamil Nadu, India

Corresponding author: Thangavelu Senthilvelkumar, Physical Therapy Unit, Rehabilitation Institute, Department of Physical Medicine and Rehabilitation, Christian Medical College, Bagayam, Vellore632002, Tamil Nadu, India. Email: [email protected]

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Senthilvelkumar et al.

Introduction Body weight-supported gait training for people with incomplete spinal cord injury is widely advocated. It has been shown to improve walking in acute and chronic incomplete spinal cord injury1–3 and other neurological conditions such as stroke,4,5 cerebral palsy6–8 and Parkinson’s disease.9,10 Body weight-supported gait training enables patients to walk with a near-normal gait pattern while their weight is relieved. This form of gait training can be provided while patients walk on a treadmill or over level ground. One of the advantages of body weight-supported treadmill training is that it is easier for the clinician to provide manual guidance, so may pose less of a manual handling risk. Other advanced gait training methods which utilise similar training principles include11 robotics,3,12,13 underwater14,15 and virtual reality training methods.16 Body weight-supported training while walking over level ground is an alternative to walking on a treadmill and is used in neurological rehabilitation.17–21 It can be a more task-specific form of gait training than treadmill training and can ease the transition from walking during therapy to walking in a real-life environment. This is because patients practice walking on surfaces similar to what they walk on day-to-day. Body weight-supported training over level ground is also appealing because it is inexpensive and does not require costly treadmills. This is a particularly important consideration for low and middle-income countries. However, it is not known whether body weight-supported training over level ground is as effective as body weight-supported training on a treadmill. To our knowledge, when this study was initiated, there was no published research on body weightsupported overground training in persons with spinal cord injury. Our hypothesis was that the body weightsupported overground training is as effective as body weight-supported treadmill training in improving walking skills in people with traumatic incomplete tetraplegia. If this hypothesis is true, body weight-supported overground training could be a viable cost-effective alternative for treadmill

training. Therefore, the purpose of this pilot randomized trial was to compare the effectiveness of these two training methods in people with traumatic incomplete tetraplegia

Methods This single blinded pilot randomized study was carried out in the rehabilitation institute of a tertiary care teaching hospital in India. All the participants gave written informed consent to participate in the study. The study protocol was approved by the Institutional Review Board and Ethics Committee. The trial was prospectively registered through Clinical Trial Registry (ID: CTRI/2008/091/000034 (registered on: 23/04/2008)]).

Inclusion/exclusion criteria The study included participants who were: (1) 18-60 years; (2) had traumatic spinal cord injury with a neurological level between C5 to C8; (3) were classified as American Spinal Injury Association Impairment Scale (ASIA) C (i.e., motor incomplete) according to the International Standards for Neurological Classification of spinal cord injury; (4) within two years from time of injury; (5) medically stable; (6) able to sit independently on a bed; and (7) able to stand for one hour with a standing frame and without orthostatic hypotension. Participants were excluded if they had: (1) heterotopic ossification; (2) prior gait training with any type of body weight-supported system; and (3) other concomitant neurological and orthopaedic issues such as head injury, peripheral nerve injuries, fractures or dislocations.

Recruitment and randomization A sample size estimate was performed in order to determine the number of participants necessary to observe a significant difference between the groups. It was calculated as 20 in each arm with the power of 80% and an alpha error of 5%. Seventy-three patients with motor incomplete tetraplegia admitted between April 2008 and

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Clinical Rehabilitation 29(1)

Assessed for eligibility =73 Reason for exclusion Did not meet inclusion criteria (n=57) • •

Excluded

Randomized (N) -16

ASIA D (n=26) ASIA C (n=31) o Heterotrophic ossification (n=1) o > 2 years post injury (n=10) o Associated illness (n=14) o Non-traumatic (n=5) o Declined to participate (n=1)

Group A (N=8)

Group B (N=8)

Body weight-supported over ground training

Body weight-supported treadmill training

30 min, 5 days/week for 8 weeks

30 min, 5 days/week for 8 weeks

Dropout=1

Dropout=1

(Family reasons)

(Social reasons)

Outcome data

Outcome data Time: 8 weeks

Time: 8 weeks

N with data=7

N with data=7

Figure 1.  The design and flow of participants through the trial.

December 2011 to our rehabilitation institution were screened for eligibility. Fifty -seven patients were excluded for various reasons (see Figure 1). Finally, 16 patients were randomized and allocated into either Group A (body weight-supported overground training) or Group B (body weightsupported treadmill training) using a computer generated block randomization with the block sizes of 2, 4 and 6 with various percentage of allocation (SAS 9.1).The random allocation sequence was generated by a statistician and kept off site by an independent person. The allocation of each participant was only revealed to the hospital staff

and site once all baseline assessments had been completed. This ensured that allocation was concealed.

Intervention Both groups received 30 minutes of gait training per day, five days a week for eight weeks. Distance of walking training was limited to the individual’s fatigability. Along with the body weight-supported training, both groups received regular training including flexibility and strengthening exercises for limbs and trunk, balance, self care and functional

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Senthilvelkumar et al. training. In addition, after three weeks of training, both groups attempted level ground walking with appropriate orthotics and assistive devices. This attempt was to identify the ambulatory status and to use it for functional purpose for their activities of daily living. This did not, however, affect the regular body weight-supported training provided to both groups. The details of the gait training provided to both groups are outlined below.

stand on an electronic treadmill after being fitted into the suspension walker with appropriate weight relief. They walked at an initial speed of one mile per hour. Gait efficiency was checked by allowing them to walk for one minute in order to adjust the weight support. Manual guidance of the legs was provided until independence in stepping was achieved.

Outcome measures Group A: body weight-supported overground training A suspension walker was used to provide body weight-support training. The suspension walker was an inexpensive and widely available custom-made, wheeled trolley with an overhead frame which relieved body weight (Supplementary material Figure 2). The participant’s bodyweight was supported by an overhead pulley and a free weight system. Initially 40% of a participant’s bodyweight was added through weights to the pulley system.22 The weights were adjusted until the participant demonstrated an efficient and comfortable gait pattern during walking. Knee flexion during stance phase of walking was used as an indication for increasing the weight support, and heel off during stance phase as an indication for reducing the weight support. Participants trained on level ground with their body weight supported. After the application of the chest harness, participants were fitted into the suspension walker and required to walk on level ground with appropriate weight relief. Gait efficiency was checked by allowing a trial walk of 10 meters to adjust the weight support if needed. Participants were allowed to walk at their selfselected speed which eliminated the need of manual assistance of legs during the training. The assistance of one person was required to progress the suspension frame for those who had limited ability to grasp and propel the suspension frame.

Group B: body weight-supported treadmill training Participants in Group B trained on a treadmill with their body weight supported. They were required to

Outcomes were measured at baseline and after eight weeks of training by an independent and blinded assessor. The primary and secondary outcomes were walking ability and muscle strength, respectively. Walking ability was measured with the Walking Index for Spinal Cord Injury II (WISCI II) and muscle strength was measured with the Lower Extremity Muscle Score (LEMS). The walking index is an ordinal scale used to assess functional limitations necessitating the use of braces and assistive devices for walking with scores ranging from 0 to 20.23,24 The lower extremity muscle score was used to assess the strength of five key lower limb muscles using manual muscle testing scores. Scores ranged from 0 to 50.25–26 Pluses and minuses were used as advocated by Daniels and Worthingham.27 Scores were transformed for analysis by adding 0.25 for a plus score and subtracting 0.25 for a minus score.28 For example a 3+ score was recorded as 3.25, and a 3- score was recorded as 2.75. In both the walking index and lower extremity muscle score, higher values indicate better performance.

Data analysis Group mean and standard deviations were calculated for descriptive data. The differences between pre-test and post-test values of lower extremity muscle score and walking index scores within the groups were analysed using Wilcoxon Signed Ranks Tests. Differences between the groups were analysed using Mann-Whitney U Tests. An alpha level of 0.05 (95% confidence interval) was considered as significant. The Statistical Package for Social Sciences (SPSS) version16.0 was used for all analyses.

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Results Sixteen participants were randomised but two participants dropped out; one in each group due to family and social reasons unrelated to the trial. Therefore data from 14 participants were used in the final analysis. There were no notable differences between the groups in baseline characteristics (Table 1). Adherence of the participants to the training was good as the mean sessions received by overground group was 37.7 out of 40 (94%) and treadmill group was 37.2/40 (93%). No adverse events were reported during the training. Figure 1 shows the design and flow of participants through the trial. Table 2 shows pre- and post-test analysis of both the groups. Walking ability In Group A, the mean Walking Index score increased from 2.1±0.7 to 12.1±4.6 [mean change = 10; 95%CI (6.6 to 13.4)] and in Group B, it increased from 3±2.3 to 12.7±5.8 [mean change=9.7; 95%CI (5.1 to14.3)]. However, there was no statistically significant difference observed between the groups [mean difference=0.3; 95% CI (-4.8 to 5.4); p=0.748]. There were two patients in the treadmill group and one in the overground group who achieved independent ambulation with cane and no brace and physical support (WISCI II -19) at the end of training. Lower extremity muscle strength In Group A, the mean Lower Extremity Muscle Score increased from 18.8±5.3 to 28.3±6.6 [mean change=9.5; 95%CI (3.2 to15.8)] and in Group B,

in increased from 19.8±6.5 to 28.6±8 [mean change=8.9; 95%CI (1.2 to 16.6)]. However, there was no statistically significant difference between the groups [mean difference=0.16; 95% CI (-3.8 to 5.1); p=0.749].

Discussion To our knowledge, this is the first systematic attempt to implement a gait training strategy for participants with incomplete tetraplegia using an inexpensive method of body weight-supported training with a suspension walker. Our key finding is that our system of gait training with overhead Table 1.  Baseline characteristics of all participants.

No of patients Age (years)#   Gender  Male  Female Time since injury (months)     6 months LEMS (0-50) WISCI II

Group A

Group B

n=7 36.5 ±13.8 (18–56)†

n=7 33.8±13.6 (18–59)†   n=5 n=2 5.9±5.2 (1–15)† n=4 n=3 19.8±6.5 3.0±2.3

n=6 n=1 5.9±4.7 (2–15)† n=4 n=3 18.8±5.3 2.1±0.7

Values are mean ± standard deviation or as otherwise indicated. †Range.

Table 2.  Comparison of outcome measures within and between the groups.

Group A† WISCI (0-20) LEMS (0-50) Group B† WISCI LEMS

Week 0

Week 8

MD (95% CI)

2.1±0.7 18.8±5.3

12.1±4.6 28.3±6.6

10 (6.6 to 13.4) 9.5 (3.2 to 15.8)

3±2.3 19.8±6.5

12.7±5.8 28.6±8

9.7 (5.1 to 14.3) 8.9 (1.2 to 16.6)

P value   0.018* 0.018*   0.018* 0.018*

Values are mean ± standard deviations or mean difference with CI, in both the scales higher values indicate better performance. MD: mean difference, CI: confidence interval. *Significant difference between pre and post test values, P

Comparison of body weight-supported treadmill training versus body weight-supported overground training in people with incomplete tetraplegia: a pilot randomized trial.

To compare the effectiveness of body weight-supported treadmill training and body weight-supported overground training for improving gait and strength...
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