Stroke
Conditions
Keywords
Robotic Rehabilitation, Mirror Therapy, Stroke Rehabilitation, Computerized Rehabilitation, Randomized Controlled Trial
Brief summary
The goal of this clinical trial is to compare the effects of three groups: (1) unilateral robotic therapy with computerized visual feedback plus unilateral innovative mirror therapy, (2) bilateral robotic therapy with computerized visual feedback plus bilateral innovative mirror therapy, and (3) dose-matched conventional rehabilitation as the control. The investigators will also study the factors predictive of treatment success, identify key predictors of clinical improvement, and distinguish patient profiles most likely to benefit from each regimen. The findings of this clinical trial are expected to advance knowledge about the synergistic effects of unilateral and bilateral hybrid programs. The predictive study of treatment outcomes will inform patient selection in precision rehabilitation toward personalized stroke management.
Interventions
OTHERRobotic therapy (RT)
The Bi-Manu-Track (BMT) robot will be provided as the robotic practice. The BMT can be switched from the bilateral practice modules involving bilateral upper limbs to the unilateral module involving the affected upper limb. According to the group assignment, participants will practice the unilateral or bilateral module of BMT training.
OTHERMirror therapy (MT)
The innovative mirror therapy (MT) program will be conducted with computerized mirror visual feedback and the conventional mirror box therapy. The unilateral MT group will practice on the unilateral module, while the bilateral MT group will practice based on the bilateral module. In the unilateral module, the affected hand will be static on the knee. In contrast, during bilateral MT, participants will be asked to do the same movements using the unaffected and affected arms as symmetrically as possible.
OTHERDose-matched control intervention
Participants in the control group will receive therapist-mediated rehabilitation per session.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(1) a first ever-stroke≧3 months and less than 2 years, (2) age range between 30 to 80 years, (3) baseline Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE) between 18 to 56, (4) no excessive muscle spasticity of the affected extremities (Modified Ashworth Scale \< 3 at any joints), (5) able to follow examiners' commands and study instructions (Montreal Cognitive Assessment score≧22), and (6) no fracture of upper extremities within the past 3 months, and (7) no participation in any other experimental rehabilitation or drug studies during study period of this project.
Exclusion criteria
(1) acute inflammation and pain, (2) receiving botulinum toxin injections within the past 3 months, and (3) concomitant neurologic, neuromuscular or orthopedic conditions that may interfere with participation in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE) | Baseline, 6 weeks, and 18 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Box and Block Test (BBT) | Baseline, 6 weeks, and 18 weeks |
| Revised Nottingham Sensory Assessment (rNSA) | Baseline, 6 weeks, and 18 weeks |
| Motor Activity Log (MAL) | Baseline, 6 weeks, and 18 weeks |
| Grip and pinch strength | Baseline, 6 weeks, and 18 weeks |
| Functional Ambulation Category (FAC) | Baseline, 6 weeks, and 18 weeks |
| Stroke Impact Scale Version 3.0 (SIS 3.0) | Baseline, 6 weeks, and 18 weeks |
| ABILHAND Questionnaire | Baseline, 6 weeks, and 18 weeks |
Countries
Taiwan
Outcome results
None listed