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

Effect of Mirror Therapy Combined With Task- vs. Impairment-oriented Rehabilitation Program in Individuals With Stroke

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Stroke; Cerebrovascular Disorders
• Intervention / Treatment: Behavioral: Mirror therapy; Behavioral: Task-oriented approach; Behavioral: Impairment-oriented approach

• Study Type: Interventional
• Enrollment (Estimated): 123
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi-chun Li, Doctor; Phone Number: 7514 +886-7-6151100; Email: joyjoyfish@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Behavioral: Task-oriented approach; The task-oriented approach will provide both bimanual common-goal and dual-goal tasks for the participants.
Experimental: 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.	Behavioral: 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.; 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.
Active Comparator: 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.	Behavioral: Task-oriented approach; The task-oriented approach will provide both bimanual common-goal and dual-goal tasks for the participants.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment	A standardized tool for evaluating motor impairment for stroke	Baseline, six weeks, and 3 months after completing the intervention
Revised Nottingham Sensory Assessment	A standardized tool for evaluating sensory impairment for stroke	Baseline, six weeks, and 3 months after completing the intervention
Chedoke Arm and Hand Activity Inventory	An assessment for bilateral functional abilities	Baseline, six weeks, and 3 months after completing the intervention
Wolf Motor Function Test	An assessment for both unilateral and bilateral functional abilities	Baseline, six weeks, and 3 months after completing the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip and pinch power	The measurements of the strength of hand movements	Baseline, six weeks, and 3 months after completing the intervention
Box and block test	A measurement for evaluating functional hand use by measuring the number of blocks moved within a set time	Baseline, six weeks, and 3 months after completing the intervention
Ten-meter walk test	A test for measuring walking speed and stride length over a fixed distance to assess mobility and functional status	Baseline, six weeks, and 3 months after completing the intervention
Berg Balance Scale	A measurement for evaluating balance abilities through a series of functional tasks	Baseline, six weeks, and 3 months after completing the intervention
Motor Activity Log	A self-report tool used to assess the amount and quality of use of an affected limb during daily activities	Baseline, six weeks, and 3 months after completing the intervention
ABILHAND Questionnaire	A self-reported assessment tool used to measure manual ability by evaluating their perceived difficulty in performing bimanual tasks	Baseline, six weeks, and 3 months after completing the intervention
Functional independent measure	An assessment tool that evaluates a person's level of disability and functional independence in performing daily activities, covering areas such as self-care, mobility, communication, and social cognition	Baseline, six weeks, and 3 months after completing the intervention
Nottingham Extended Activities of Daily Living Scale	An assessment tool designed to measure a person's ability to perform daily activities	Baseline, six weeks, and 3 months after completing the intervention
Stoke Impact Scale	A comprehensive self-reported questionnaire that assesses the impact of a stroke on life	Baseline, six weeks, and 3 months after completing the intervention
Stroke Self-Efficacy Questionnaire	A tool used to evaluate a stroke survivor's confidence to perform daily activities	Baseline, six weeks, and 3 months after completing the intervention
Stroke-Specific Measure of Adherence to Home-based Exercises	A questionnaire designed to assess how consistently stroke participations follow prescribed home programs	Six weeks

Collaborators and Investigators

• Sponsor: I-Shou University
• Investigators: Principal Investigator: Yi-chun Li, Doctor, I-Shou University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: June 29, 2024
• First Submitted That Met QC Criteria: June 29, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: June 29, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Mirror Therapy
• Additional Relevant MeSH Terms: Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: ISU-OT-Li-01

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