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

June 29, 2024 updated by: Yi-chun Li, I-Shou University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
123

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment
Time Frame: Baseline, six weeks, and 3 months after completing the intervention
A standardized tool for evaluating motor impairment for stroke
Baseline, six weeks, and 3 months after completing the intervention
Revised Nottingham Sensory Assessment
Time Frame: Baseline, six weeks, and 3 months after completing the intervention
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
Time Frame: Baseline, six weeks, and 3 months after completing the intervention
An assessment for bilateral functional abilities
Baseline, six weeks, and 3 months after completing the intervention
Wolf Motor Function Test
Time Frame: Baseline, six weeks, and 3 months after completing the intervention
An assessment for both unilateral and bilateral functional abilities
Baseline, six weeks, and 3 months after completing the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Grip and pinch power
Time Frame: Baseline, six weeks, and 3 months after completing the intervention
The measurements of the strength of hand movements
Baseline, six weeks, and 3 months after completing the intervention
Box and block test
Time Frame: Baseline, six weeks, and 3 months after completing the intervention
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
Time Frame: Baseline, six weeks, and 3 months after completing the intervention
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
Time Frame: Baseline, six weeks, and 3 months after completing the intervention
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
Time Frame: Baseline, six weeks, and 3 months after completing the intervention
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
Time Frame: Baseline, six weeks, and 3 months after completing the intervention
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
Time Frame: Baseline, six weeks, and 3 months after completing the intervention
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
Time Frame: Baseline, six weeks, and 3 months after completing the intervention
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
Time Frame: Baseline, six weeks, and 3 months after completing the intervention
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
Time Frame: Baseline, six weeks, and 3 months after completing the intervention
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
Time Frame: Six weeks
A questionnaire designed to assess how consistently stroke participations follow prescribed home programs
Six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
I-Shou University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yi-chun Li, Doctor, I-Shou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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