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NCT Number: NCT06489938

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Serious medical problems or poor physical conditions that might be detrimental to study participation.

Treatment and study plan

Mirror Therapy

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

Behavioral

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

Impairment-oriented approach

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.

Primary outcomes

  1. Fugl-Meyer Assessment

    Time frame: Baseline, six weeks, and 3 months after completing the intervention

    A standardized tool for evaluating motor impairment for stroke

  2. 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

  3. Chedoke Arm and Hand Activity Inventory

    Time frame: Baseline, six weeks, and 3 months after completing the intervention

    An assessment for bilateral functional abilities

  4. 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

Secondary outcomes

  1. Grip and pinch power

    Time frame: Baseline, six weeks, and 3 months after completing the intervention

    The measurements of the strength of hand movements

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Yi-chun Li, Doctor

CONTACT

[email protected]

+886-7-6151100 ext. 7514

Sponsors and collaborators

Lead sponsor

I-Shou University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jul 8, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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