Robot-assisted Gait Training for Patients With Stroke

Study Overview
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Brief Summary
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Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for stroke survivors. It is anticipated that robot-assisted gait rehabilitation in combination with standard hospital based rehabilitation will achieve significantly better gait outcomes than standard hospital based rehabilitation alone.

Detailed Description
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Stroke is the leading cause of permanent disability in most developed countries world wide with one-third of the surviving patients from stroke fail to regain independent walking ability. Robot-assisted gait rehabilitation that is able to deliver high intensity and consistent repeatability in a safe and controlled environment are gaining traction and advocators for its inclusion as part of the routine post-stroke rehabilitation program. However, despite the recent technological advances in the development and design of better robotics, the exact benefit of the robot-assisted therapy over traditional rehabilitation remain sparse and unclear. It is therefore the aim of the proposed project to fulfil this important gap in our clinical knowledge by comparatively investigate the clinical feasibility and efficacy of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of functional recovery and the appropriate gait adaptation of such robotic system for stroke survivors.

Official Title
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Clinical Feasibility and Efficacy of Robot-assisted Gait Training for Improving Motor Functions in Patients With Stroke

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Procedure: Standard rehab
* Device: Robot-assisted gait rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the age of 20-65 years; Diagnosis of first, single unilateral cortical-subcortical stroke verified by brain imaging; Paresis of a lower limb; Inability to walk without aid or device. Exclusion Criteria: Deemed by a physician to be medically unstable; Other prior musculoskeletal conditions that affected gait capacity; Co-existence of other neurological diseases; Cognitive impairments that would impact on the safe participation in the study (MMSE<23) -

Ages Eligible for Study
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Minimum Age: 20 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: Standard Rehabilitation<br>Patient with stroke receiving standard hospital based rehabilitation program | Procedure: Standard rehab<br>* Standard hospital based rehabilitation for patients with stroke<br>|
| Experimental: Robot-assisted Rehabilitation<br>Patient with stroke receiving standard hospital based rehabilitation as well as robot-assisted gait rehabilitation program | Device: Robot-assisted gait rehabilitation<br>* An extra 30 minutes of robot-assisted gait rehabilitation after receiving standard hospital based rehabilitation for patients with stroke<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment, lower extremity subscale | Lower limb function as measured by Fugl-Meyer Assessment, lower extremity subscale | Assessing change from baseline after 1 month of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Ambulation Categories | Categorizes patients according to basic motor skills necessary for functional ambulation | Assessing change from baseline after 1 month of intervention | 
| 10 Meters Walking Test | Assesses walking speed in meters per second over a short duration | Assessing change from baseline after 1 month of intervention | 
| Berg Balance Scale | testing a participant's static and dynamic balance abilities | Assessing change from baseline after 1 month of intervention | 
| Timed Up and Go test | Assess a participant's mobility and requires both static and dynamic balance | Assessing change from baseline after 1 month of intervention | 
| Kinetic and Kinematic Gait Analysis | The temporo-spatial and kinematic gait parameters of the participants will be assessed using a Vicon Motion Analysis System with kinetic data collection through a force plate. | Assessing change from baseline after 1 month of intervention |