Cerebrovascular Accident
Conditions
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.
Interventions
PROCEDUREStandard rehab
Standard hospital based rehabilitation for patients with stroke
DEVICERobot-assisted gait rehabilitation
An extra 30 minutes of robot-assisted gait rehabilitation after receiving standard hospital based rehabilitation for patients with stroke
Sponsors
HIWIN Technologies Corporation
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Between the age of 20-65 years; 2. Diagnosis of first, single unilateral cortical-subcortical stroke verified by brain imaging; 3. Paresis of a lower limb; 4. Inability to walk without aid or device.
Exclusion criteria
1. Deemed by a physician to be medically unstable; 2. Other prior musculoskeletal conditions that affected gait capacity; 3. Co-existence of other neurological diseases; 4. Cognitive impairments that would impact on the safe participation in the study (MMSE\<23) -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Contacts
Primary ContactNai-Hsin Meng, M.D.
Outcome results
None listed