Robot-assisted Gait Training for Patients With Stroke
- Conditions
- Cerebrovascular Accident
- Interventions
- Procedure: Standard rehabDevice: Robot-assisted gait rehabilitation
- Registration Number
- NCT02781831
- Lead Sponsor
- China Medical University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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) -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Rehabilitation Standard rehab Patient with stroke receiving standard hospital based rehabilitation program Robot-assisted Rehabilitation Robot-assisted gait rehabilitation Patient with stroke receiving standard hospital based rehabilitation as well as robot-assisted gait rehabilitation program
- Primary Outcome Measures
Name Time Method Fugl-Meyer Assessment, lower extremity subscale Assessing change from baseline after 1 month of intervention Lower limb function as measured by Fugl-Meyer Assessment, lower extremity subscale
- Secondary Outcome Measures
Name Time Method Functional Ambulation Categories Assessing change from baseline after 1 month of intervention Categorizes patients according to basic motor skills necessary for functional ambulation
10 Meters Walking Test Assessing change from baseline after 1 month of intervention Assesses walking speed in meters per second over a short duration
Berg Balance Scale Assessing change from baseline after 1 month of intervention testing a participant's static and dynamic balance abilities
Timed Up and Go test Assessing change from baseline after 1 month of intervention Assess a participant's mobility and requires both static and dynamic balance
Kinetic and Kinematic Gait Analysis Assessing change from baseline after 1 month of intervention 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.
Trial Locations
- Locations (1)
China Medical University Hospial
đŸ‡¨đŸ‡³Taichung City, Taiwan