Robotic Therapy Hybridized With Mirror Therapy in Stroke Rehabilitation

March 25, 2025 updated by: National Taiwan University Hospital

Unilateral and Bilateral Approaches to Robotic Therapy Hybridized With Mirror Therapy in Stroke Rehabilitation

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, Taiwan
        • Wan Fang Hospital, Taipei Medical University
      • Taipei, Taiwan, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unilateral RT plus unilateral innovative MT
Unilateral robotic therapy (RT) with computerized visual feedback plus unilateral innovative mirror therapy (MT)
Other: Robotic 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.
Other: Mirror 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.
Experimental: Bilateral RT plus bilateral innovative MT
Bilateral robotic therapy (RT) with computerized visual feedback plus bilateral innovative mirror therapy (MT)
Other: Robotic 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.
Other: Mirror 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.
Active Comparator: Dose-matched conventional rehabilitation
Dose-matched conventional rehabilitation as the control
Other: Dose-matched control intervention
Participants in the control group will receive therapist-mediated rehabilitation per session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE)
Time Frame: Baseline, 6 weeks, and 18 weeks
Baseline, 6 weeks, and 18 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2025

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202410139RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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