Clinical Feasibility and Efficacy of Robot-assisted Gait Training for Improving Motor Functions in Patients With Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebrovascular Accident
- Sponsor
- China Medical University Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Fugl-Meyer Assessment, lower extremity subscale
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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) -
Outcomes
Primary Outcomes
Fugl-Meyer Assessment, lower extremity subscale
Time Frame: Assessing change from baseline after 1 month of intervention
Lower limb function as measured by Fugl-Meyer Assessment, lower extremity subscale
Secondary Outcomes
- Functional Ambulation Categories(Assessing change from baseline after 1 month of intervention)
- 10 Meters Walking Test(Assessing change from baseline after 1 month of intervention)
- Berg Balance Scale(Assessing change from baseline after 1 month of intervention)
- Timed Up and Go test(Assessing change from baseline after 1 month of intervention)
- Kinetic and Kinematic Gait Analysis(Assessing change from baseline after 1 month of intervention)