Robotic Therapy Hybridized With Mirror Therapy in Stroke Rehabilitation

National Taiwan University

Status: Invitation-only

Conditions: Stroke

Treatments: Other: Mirror therapy (MT); Other: Dose-matched control intervention; Other: Robotic therapy (RT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06777654

202410139RIND

Details and patient eligibility

About

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.

Enrollment: 81 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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81 participants in 3 patient groups

Unilateral RT plus unilateral innovative MT

Experimental group

Description:

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

Treatment:

Other: Robotic therapy (RT)

Other: Mirror therapy (MT)

Bilateral RT plus bilateral innovative MT

Experimental group

Description:

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

Treatment:

Other: Robotic therapy (RT)

Other: Mirror therapy (MT)

Dose-matched conventional rehabilitation

Active Comparator group

Description:

Dose-matched conventional rehabilitation as the control

Treatment:

Other: Dose-matched control intervention