Robotic Therapy Hybridized With Mirror Therapy in Stroke Rehabilitation

NCT06777654 | Enrolling By Invitation DMC

• 1 other identifier: 202410139RIND
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

Robotic Rehabilitation; Mirror Therapy; Stroke Rehabilitation; Computerized Rehabilitation; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE)

  Baseline, 6 weeks, and 18 weeks

Secondary Outcomes (7)

• Grip and pinch strength

  Baseline, 6 weeks, and 18 weeks

• 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

• ABILHAND Questionnaire

  Baseline, 6 weeks, and 18 weeks

Study Arms (3)

Unilateral RT plus unilateral innovative MT

EXPERIMENTAL

Unilateral robotic therapy (RT) with computerized visual feedback plus unilateral innovative mirror therapy (MT)

Other: Robotic therapy (RT); Other: Mirror therapy (MT)

Bilateral RT plus bilateral innovative MT

EXPERIMENTAL

Bilateral robotic therapy (RT) with computerized visual feedback plus bilateral innovative mirror therapy (MT)

Other: Robotic therapy (RT); Other: Mirror therapy (MT)

Dose-matched conventional rehabilitation

ACTIVE COMPARATOR

Dose-matched conventional rehabilitation as the control

Other: Dose-matched control intervention

Interventions

Robotic therapy (RT) OTHER

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.

Bilateral RT plus bilateral innovative MT; Unilateral RT plus unilateral innovative MT

Mirror therapy (MT) OTHER

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.

Bilateral RT plus bilateral innovative MT; Unilateral RT plus unilateral innovative MT

Dose-matched control intervention OTHER

Participants in the control group will receive therapist-mediated rehabilitation per session.

Dose-matched conventional rehabilitation

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

Wan Fang Hospital, Taipei Medical University

Taipei, Taiwan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: March 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)