Mirror Therapy Combined With Task- vs. Impairment-oriented Rehabilitation Program

NCT ID: NCT06489938

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2030-12-31

Brief Summary

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The goal of this clinical trial is to examine the effects of mirror therapy combined with task- vs. Impairment-oriented rehabilitation programs as novel hybrid approaches in individuals with stroke. Participants will receive mirror therapy combined with the task-oriented rehabilitation program (MTT), mirror therapy combined with the impairment-oriented rehabilitation program (MTI), or task-oriented rehabilitation program combined with the impairment-oriented rehabilitation program (TI) 90 minutes per day, three days per week, for six weeks.

Detailed Description

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Conditions

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Cardiovascular Diseases Stroke Cerebrovascular Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mirror therapy combined with the task-oriented approach (MTT)

Each participant will receive the mirror therapy combined with the task-oriented approach 90 minutes daily, three days per week for six weeks.

Group Type EXPERIMENTAL

Mirror therapy

Intervention Type BEHAVIORAL

In mirror therapy, a wooden mirror (41×50×33 cm3) will be positioned in the participant's sagittal midplane, blocking the participant's view of the affected arm performance. We will also provide a foldable bed tray table to ensure that the participants focus on the mirror reflection of the less affected arm. The mirror therapy will consist of movement and functional practices.

Task-oriented approach

Intervention Type BEHAVIORAL

The task-oriented approach will provide both bimanual common-goal and dual-goal tasks for the participants.

Mirror therapy combined with the impairment-oriented approach (MTI)

Each participant will receive the mirror therapy combined with the impairment-oriented approach 90 minutes daily, three days per week for six weeks.

Group Type EXPERIMENTAL

Mirror therapy

Intervention Type BEHAVIORAL

In mirror therapy, a wooden mirror (41×50×33 cm3) will be positioned in the participant's sagittal midplane, blocking the participant's view of the affected arm performance. We will also provide a foldable bed tray table to ensure that the participants focus on the mirror reflection of the less affected arm. The mirror therapy will consist of movement and functional practices.

Impairment-oriented approach

Intervention Type BEHAVIORAL

The impairment-oriented approach will focus on the movement components. Arm BASIS or Arm Ability training will be provided based on the severity of the participant's impairment.

Task-oriented rehabilitation program combined with impairment-oriented rehabilitation program (TI)

Each participant will receive the task-oriented rehabilitation program combined with the impairment-oriented rehabilitation program 90 minutes daily, three days per week for six weeks.

Group Type ACTIVE_COMPARATOR

Task-oriented approach

Intervention Type BEHAVIORAL

The task-oriented approach will provide both bimanual common-goal and dual-goal tasks for the participants.

Impairment-oriented approach

Intervention Type BEHAVIORAL

The impairment-oriented approach will focus on the movement components. Arm BASIS or Arm Ability training will be provided based on the severity of the participant's impairment.

Interventions

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Mirror therapy

In mirror therapy, a wooden mirror (41×50×33 cm3) will be positioned in the participant's sagittal midplane, blocking the participant's view of the affected arm performance. We will also provide a foldable bed tray table to ensure that the participants focus on the mirror reflection of the less affected arm. The mirror therapy will consist of movement and functional practices.

Intervention Type BEHAVIORAL

Task-oriented approach

The task-oriented approach will provide both bimanual common-goal and dual-goal tasks for the participants.

Intervention Type BEHAVIORAL

Impairment-oriented approach

The impairment-oriented approach will focus on the movement components. Arm BASIS or Arm Ability training will be provided based on the severity of the participant's impairment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. A first-ever unilateral stroke ≥3 months
2. Age between 20 and 80 years
3. Baseline Fugl-Meyer Assessment Upper Extremity (FMA-UE) score \>10
4. No severe spasticity in any joints of the affected arm
5. Ability to follow the instructions
6. No participation in other studies during the study period
7. Willingness to provide informed written consent.

Exclusion Criteria

1\. Serious medical problems or poor physical conditions that might be detrimental to study participation.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I-Shou University

OTHER

Sponsor Role lead

Responsible Party

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Yi-chun Li

Neuro-Rehabilitation Research Laboratory (NRRL)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi-chun Li, Doctor

Role: PRINCIPAL_INVESTIGATOR

I-Shou University

Central Contacts

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Yi-chun Li, Doctor

Role: CONTACT

+886-7-6151100 ext. 7514

Other Identifiers

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ISU-OT-Li-01

Identifier Type: -

Identifier Source: org_study_id

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