Clinical trial NCT06489938: Mirror Therapy Combined With Task- vs. Impairment-oriented Rehabilitation Program
Official title: Effect of Mirror Therapy Combined With Task- vs. Impairment-oriented Rehabilitation Program in Individuals With Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Stroke
Cerebrovascular Disorders
Keywords: Rehabilitation
Mirror Therapy
Lead sponsor: I-Shou University
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 123
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: Baseline, six weeks, and 3 months after completing the intervention
measure: Revised Nottingham Sensory Assessment
timeFrame: Baseline, six weeks, and 3 months after completing the intervention
measure: Chedoke Arm and Hand Activity Inventory
timeFrame: Baseline, six weeks, and 3 months after completing the intervention
measure: Wolf Motor Function Test
timeFrame: Baseline, six weeks, and 3 months after completing the intervention
Secondary outcomes:
measure: Grip and pinch power
timeFrame: Baseline, six weeks, and 3 months after completing the intervention
measure: Box and block test
timeFrame: Baseline, six weeks, and 3 months after completing the intervention
measure: Ten-meter walk test
timeFrame: Baseline, six weeks, and 3 months after completing the intervention
measure: Berg Balance Scale
timeFrame: Baseline, six weeks, and 3 months after completing the intervention
measure: Motor Activity Log
timeFrame: Baseline, six weeks, and 3 months after completing the intervention
measure: ABILHAND Questionnaire
timeFrame: Baseline, six weeks, and 3 months after completing the intervention
measure: Functional independent measure
timeFrame: Baseline, six weeks, and 3 months after completing the intervention
measure: Nottingham Extended Activities of Daily Living Scale
timeFrame: Baseline, six weeks, and 3 months after completing the intervention
measure: Stoke Impact Scale
timeFrame: Baseline, six weeks, and 3 months after completing the intervention
measure: Stroke Self-Efficacy Questionnaire
timeFrame: Baseline, six weeks, and 3 months after completing the intervention
measure: Stroke-Specific Measure of Adherence to Home-based Exercises
timeFrame: Six weeks
Other outcomes:
Locations:
Study officials:
affiliation: I-Shou University
name: Yi-chun Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References: