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Enrolling by invitation NCT06777654

Robotic Therapy Hybridized With Mirror Therapy in Stroke Rehabilitation

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robotic therapy (RT), Mirror therapy (MT), Dose-matched control intervention.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 30 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 po
  • Other Dose-matched control intervention
    Participants in the control group will receive therapist-mediated rehabilitation per session.

Primary outcome measures

  • Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE) [Time frame: Baseline, 6 weeks, and 18 weeks]
Secondary outcome measures (7)
  • Grip and pinch strength [Time frame: Baseline, 6 weeks, and 18 weeks]
  • Box and Block Test (BBT) [Time frame: Baseline, 6 weeks, and 18 weeks]
  • Revised Nottingham Sensory Assessment (rNSA) [Time frame: Baseline, 6 weeks, and 18 weeks]
  • Motor Activity Log (MAL) [Time frame: Baseline, 6 weeks, and 18 weeks]
  • ABILHAND Questionnaire [Time frame: Baseline, 6 weeks, and 18 weeks]
  • Functional Ambulation Category (FAC) [Time frame: Baseline, 6 weeks, and 18 weeks]
  • Stroke Impact Scale Version 3.0 (SIS 3.0) [Time frame: Baseline, 6 weeks, and 18 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 2 centers
  • Wan Fang Hospital, Taipei Medical University — Taipei
  • National Taiwan University Hospital — Taipei, Taiwan

Identifiers

NCT: NCT06777654 · 202410139RIND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗