Clinical trial NCT06777654: Robotic Therapy Hybridized With Mirror Therapy in Stroke Rehabilitation
Official title: Unilateral and Bilateral Approaches to Robotic Therapy Hybridized With Mirror Therapy in Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Keywords: Robotic Rehabilitation
Mirror Therapy
Stroke Rehabilitation
Computerized Rehabilitation
Randomized Controlled Trial
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 81
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE)
timeFrame: Baseline, 6 weeks, and 18 weeks
Secondary outcomes:
measure: Grip and pinch strength
timeFrame: Baseline, 6 weeks, and 18 weeks
measure: Box and Block Test (BBT)
timeFrame: Baseline, 6 weeks, and 18 weeks
measure: Revised Nottingham Sensory Assessment (rNSA)
timeFrame: Baseline, 6 weeks, and 18 weeks
measure: Motor Activity Log (MAL)
timeFrame: Baseline, 6 weeks, and 18 weeks
measure: ABILHAND Questionnaire
timeFrame: Baseline, 6 weeks, and 18 weeks
measure: Functional Ambulation Category (FAC)
timeFrame: Baseline, 6 weeks, and 18 weeks
measure: Stroke Impact Scale Version 3.0 (SIS 3.0)
timeFrame: Baseline, 6 weeks, and 18 weeks
Other outcomes:
Locations:
city: Taipei, Taiwan
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Wan Fang Hospital, Taipei Medical University
Study officials:
References: