Perturbed-balance Training During Treadmill Walking for Stroke Subjects

Study Overview
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Brief Summary
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A control and a post-stroke subject with right-side chronic hemiparesis were studied. The post-stroke subject underwent 30 sessions of balance-perturbed training while walking on an instrumented treadmill where the Balance Assessment Robot (BAR™) randomly delivered pushes to pelvis in various directions at various speeds and at various perturbation amplitudes. The investigators assessed kinematics, kinetics, electromiography and spatio-temporal responses to outward-directed perturbations commencing either at foot contact of the left or the right leg.

Detailed Description
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For a detailed description of the study, see the Arms and Interventions section.

Official Title
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Feasibility of Perturbed-balance Training During Treadmill Walking in a High-functioning Chronic Stroke Subject: a Case-control Study

Conditions
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Stroke

Intervention / Treatment
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* Device: Balance Assessment Robot (BAR™)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Case: community-dwelling, high-functioning stroke survivor Control: healthy volunteer, height- and weight-matched to the Case Exclusion criteria: any disease or injury affecting cognition any disease or injury affecting balance or gait
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case - stroke survivor<br>Stroke survivor, 6mon post stroke resulting in right-sided hemiparesis, 53yrs old, had completed a 2mon rehabilitation program prior to the study. He underwent 30 training sessions with the Balance Assessment Robot (BAR™) within a 10-week period, each consisting of 10-15min of unperturbed treadmill and 30-45min of perturbation training. Perturbations were delivered in the forward, backward, left and right direction, occurring every 6sec, at the left leg initial contact and the right leg initial contact. Two training sessions were spent to determine adequate treadmill speed (0.4m/s) and perturbation amplitude (60N), followed by the first assessment session. After the last training session, assessment was repeated using the same parameters plus 90N perturbation amplitude. | Device: Balance Assessment Robot (BAR™)<br>* The BAR™ has got six degrees of freedom (DOF) that interface to the pelvis of a walking subject. Five DOFs (translation of pelvis in sagittal, lateral and vertical directions; pelvic rotation and pelvic list) are actuated and admittance-controlled, providing transparent haptic interaction with negligible power transfer; the remaining DOF (pelvic tilt) is passive. The BAR™ is capable of delivering perturbations in the directions forward/backward and left/right, but for the purpose of this study only outward perturbations in the frontal plane were considered.<br>|
| Active Comparator: Control - matched healthy subject<br>Healthy male, height- and weight-matched to the Case. He was assessed according to the same protocol as the Case using the Balance Assessment Robot (BAR™) at perturbation amplitudes 60 and 90 N. | Device: Balance Assessment Robot (BAR™)<br>* The BAR™ has got six degrees of freedom (DOF) that interface to the pelvis of a walking subject. Five DOFs (translation of pelvis in sagittal, lateral and vertical directions; pelvic rotation and pelvic list) are actuated and admittance-controlled, providing transparent haptic interaction with negligible power transfer; the remaining DOF (pelvic tilt) is passive. The BAR™ is capable of delivering perturbations in the directions forward/backward and left/right, but for the purpose of this study only outward perturbations in the frontal plane were considered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in centre of mass of the Case | For the purpose of qualitative assessment of kinematics and kinetics | Assessment at session no. 3 (during week 1) and session no. 30 (during week 10) | 
| Change in centre of pressure of the Case | For the purpose of qualitative assessment of kinematics and kinetics | Assessment at session no. 3 (during week 1) and session no. 30 (during week 10) | 
| Change in ground reaction force of the Case | For the purpose of qualitative assessment of kinematics and kinetics | Assessment at session no. 3 (during week 1) and session no. 30 (during week 10) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Centre of mass of the Control | For the purpose of qualitative assessment of spatio-temporal characteristics of stepping | During the only session (i.e., session 1 on day 1) | 
| Centre of pressure of the Control | For the purpose of qualitative assessment of spatio-temporal characteristics of stepping | During the only session (i.e., session 1 on day 1) | 
| Ground reaction force of the Control | For the purpose of qualitative assessment of spatio-temporal characteristics of stepping | During the only session (i.e., session 1 on day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perturbed walking, stepping response