Comparison of Post-pinal Cord Injury (SCI) Locomotor Training Techniques

Study Overview
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Brief Summary
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Background: Body weight supported (BWS) locomotor training improves overground walking ability in individuals with motor-incomplete spinal cord injury (SCI). While there are various approaches available for locomotor training, there is no consensus regarding which of these is optimal. The purpose of this ongoing investigation is to compare outcomes associated with these different training approaches. Subjects and Methods: Subjects with chronic motor-incomplete SCI have completed training and initial and final testing. Subjects were randomly assigned to 1 of 4 different BWS assisted-stepping groups, including: 1) treadmill training with manual assistance (TM), 2) treadmill training with stimulation (TS), 3) overground training with stimulation (OG), or 4) treadmill training with robotic assistance (LR). Prior to and following participation the investigators assessed: Walking-related outcome measures: overground walking speed, training speed, step length and step symmetry. Spinal cord reflex activity Electromyographic (EMG) associated with walking Hypotheses: In individuals with incomplete spinal cord injury (SCI): A 12-week period of body weight supported treadmill training with TS will produce improvements in walking function that are significantly greater than those produced by training with TM, OG, LR. TS training will be associated with greater changes to spinal reflex activity than will be observed in subjects trained with manual assistance or non-assisted stepping. Changes to spinal reflex activation will be such that this activity more closely resembles that observed in non-disabled (ND) individuals. Following participation in this walking regimen, EMG activity observed during walking in all groups will be more robust, more consistent and better coordinated than EMG measures obtained prior to training.

Official Title
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Comparison of Post-SCI Locomotor Training Techniques

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Other: Locomotor training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: motor-incomplete spinal cord injury (AIS C or D) at least one year post injury able to step with at at least one leg able to stand from chair with no more than moderate assist of 1 person Exclusion Criteria: unstable neurologic status active orthopedic problem

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treadmill training - manual assist (TM)<br>Participants in the TM group received partial body weight support unilateral or bilateral manual assistance from a trainer for stepping | Other: Locomotor training<br>* Locomotor training using body weight support with training on a treadmill or training over ground with differing forms of assistance for stepping<br>|
| Active Comparator: Treadmill training - electrical stimulation (TS)<br>Participants in the TS group received partial body weight support and bilateral functional electrical stimulation to assist stepping | Other: Locomotor training<br>* Locomotor training using body weight support with training on a treadmill or training over ground with differing forms of assistance for stepping<br>|
| Active Comparator: Overground Training (OG)<br>Training over ground with body weight support and electrical stimulation for dorsiflex assistance | Other: Locomotor training<br>* Locomotor training using body weight support with training on a treadmill or training over ground with differing forms of assistance for stepping<br>|
| Active Comparator: Treadmill training - locomat robot (LR)<br>Treadmill training with partical body weight support and assistance of a robotic gait orthosis for stepping | Other: Locomotor training<br>* Locomotor training using body weight support with training on a treadmill or training over ground with differing forms of assistance for stepping<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking speed | Walking speed collected during 10-Meter Walk Test | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional walking capacity | Distance walked in timed 2-Minute Walk Test | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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task-specific training, walking, locomotion, function, body weight support, Individuals with motor-incomplete spinal cord injury