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Enrolling by Invitation

NCT Number: NCT06777654

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.

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Key information

Conditions

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

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Dose-matched control intervention

Other

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

Primary outcomes

  1. Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE)

    Time frame: Baseline, 6 weeks, and 18 weeks

Secondary outcomes

  1. Grip and pinch strength

    Time frame: Baseline, 6 weeks, and 18 weeks

  2. Box and Block Test (BBT)

    Time frame: Baseline, 6 weeks, and 18 weeks

  3. Revised Nottingham Sensory Assessment (rNSA)

    Time frame: Baseline, 6 weeks, and 18 weeks

  4. Motor Activity Log (MAL)

    Time frame: Baseline, 6 weeks, and 18 weeks

  5. ABILHAND Questionnaire

    Time frame: Baseline, 6 weeks, and 18 weeks

  6. Functional Ambulation Category (FAC)

    Time frame: Baseline, 6 weeks, and 18 weeks

  7. Stroke Impact Scale Version 3.0 (SIS 3.0)

    Time frame: Baseline, 6 weeks, and 18 weeks

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 16, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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