Robotic Therapy Hybridized With Mirror Therapy in Stroke Rehabilitation

Not Applicable

• Conditions: Stroke

• Registration Number: NCT06777654
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-27
• Study Start: 2025-03-31
• Primary Completion: 2028-07-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE)	Baseline, 6 weeks, and 18 weeks

Secondary Outcome Measures

Name	Time	Method
Grip and pinch strength	Baseline, 6 weeks, and 18 weeks
Motor Activity Log (MAL)	Baseline, 6 weeks, and 18 weeks
Box and Block Test (BBT)	Baseline, 6 weeks, and 18 weeks
ABILHAND Questionnaire	Baseline, 6 weeks, and 18 weeks
Revised Nottingham Sensory Assessment (rNSA)	Baseline, 6 weeks, and 18 weeks
Stroke Impact Scale Version 3.0 (SIS 3.0)	Baseline, 6 weeks, and 18 weeks
Functional Ambulation Category (FAC)	Baseline, 6 weeks, and 18 weeks

Trial Locations

Locations (2)

Wan Fang Hospital, Taipei Medical University; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan, Taiwan