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
1 other identifier
interventional
123
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cardiovascular-diseases
Started Jul 2024
Longer than P75 for not_applicable cardiovascular-diseases
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedFirst Posted
Study publicly available on registry
July 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
July 8, 2024
June 1, 2024
6.5 years
June 29, 2024
June 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (11)
Grip and pinch power
Baseline, six weeks, and 3 months after completing the intervention
Box and block test
Baseline, six weeks, and 3 months after completing the intervention
Ten-meter walk test
Baseline, six weeks, and 3 months after completing the intervention
Berg Balance Scale
Baseline, six weeks, and 3 months after completing the intervention
Motor Activity Log
Baseline, six weeks, and 3 months after completing the intervention
- +6 more secondary outcomes
Study Arms (3)
Mirror therapy combined with the task-oriented approach (MTT)
EXPERIMENTALEach participant will receive the mirror therapy combined with the task-oriented approach 90 minutes daily, three days per week for six weeks.
Mirror therapy combined with the impairment-oriented approach (MTI)
EXPERIMENTALEach participant will receive the mirror therapy combined with the impairment-oriented approach 90 minutes daily, three days per week for six weeks.
Task-oriented rehabilitation program combined with impairment-oriented rehabilitation program (TI)
ACTIVE COMPARATOREach 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.
Interventions
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.
The task-oriented approach will provide both bimanual common-goal and dual-goal tasks for the participants.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \. Serious medical problems or poor physical conditions that might be detrimental to study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi-chun Li, Doctor
I-Shou University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neuro-Rehabilitation Research Laboratory (NRRL)
Study Record Dates
First Submitted
June 29, 2024
First Posted
July 8, 2024
Study Start
July 1, 2024
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
July 8, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share