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Clinical Trials/NCT06103045
NCT06103045
Completed
Not Applicable

The Effects of Unilateral and Bilateral Mirror Therapy on Upper Extremity Function of Stroke at Acute Stage: A Pilot Randomized Controlled Trial.

National Taiwan University Hospital Hsin-Chu Branch1 site in 1 country49 target enrollmentFebruary 7, 2023
ConditionsStroke, Acute

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Acute
Sponsor
National Taiwan University Hospital Hsin-Chu Branch
Enrollment
49
Locations
1
Primary Endpoint
The Jamar Hydraulic Hand Dynamometer
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

Objective: To comparing the effects of unilateral and bilateral mirror therapy on upper extremity function of stroke at acute stage. We hypothesize there are different effects between unilateral and bilateral mirror therapy on stroke patients at acute stage. Method: Patients with unilateral stroke and the onset within one month will be recruited and then randomly allocated to one of the three groups (including unilateral mirror therapy, bilateral mirror therapy, and conventional occupational therapy). Patient will receive 20 consecutive sessions of intervention (5 time per week, totally 4 weeks) and assessments before and after the intervention within one week. In each intervention session, patients will receive 30 minutes unilateral or bilateral mirror therapy depending on their allocated groups and then 30 conventional occupational therapy. The patients recruited in the conventional occupational therapy group will receive 60 minute conventional therapy. The outcome measures at pre- and post-treatment will including the Fugl-Meyer Assessment for upper extremity (FMA-UE), the Modified Ashworth Scale (MAS), the Jamar Hydraulic Hand Dynamometer, the Chedoke Arm and Hand Activity Inventory (CAHAI), the Revised Nottingham Sensory Assessment (rNSA), and Functional Independence Measurement (FIM).

Registry
clinicaltrials.gov
Start Date
February 7, 2023
End Date
July 4, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Taiwan University Hospital Hsin-Chu Branch
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Unilateral stroke onset within 1 month
  • The score of Mini-Mental State Examination (MMSE) is more than 24
  • The score of Fugl-Meyer Assessment for upper extremity (FMA-UE) is between 18 to 56
  • The score of Modified Ashworth Scale (MAS) is less than 3
  • Willing to receive 3-5 sessions of the intervention per week, total 20 sessions consecutively
  • Willing to sign informed consent

Exclusion Criteria

  • Unstable vital sign or complicating with other symptoms of neurological disease
  • Auditory or visual function impairment
  • Complicating with perceptual impairment (e.g., apraxia, neglect, or visual agnosia)
  • Receiving botulinum toxin injection within 3 months
  • Complicating with Wernicke's or Broca's aphasia

Outcomes

Primary Outcomes

The Jamar Hydraulic Hand Dynamometer

Time Frame: pre-treatment: before intervention within a week; post-treatment: after intervention within a week

The Jamar Hydraulic Hand Dynamometer is a gold standard assessment tool for measuring muscle power including the grip strength, palmar pinch, and lateral pinch.

Fugl-Meyer Assessment for upper extremity (FMA-UE)

Time Frame: pre-treatment: before intervention within a week; post-treatment: after intervention within a week

The FMA-UE is a commonly used assessment in clinical for the extent of motor impairment of upper extremity post-stroke. The score ranged from 0 to 66. The psychometric properties of the FMA-UE had established, and there was also good responsiveness in the past studies.

Secondary Outcomes

  • Revised Nottingham Sensory Assessment (rNSA)(pre-treatment: before intervention within a week; post-treatment: after intervention within a week)
  • Chedoke Arm and Hand Activity Inventory (CAHAI)(pre-treatment: before intervention within a week; post-treatment: after intervention within a week)
  • Functional Independence Measurement (FIM)(pre-treatment: before intervention within a week; post-treatment: after intervention within a week)
  • Modified Ashworth Scale (MAS)(pre-treatment: before intervention within a week; post-treatment: after intervention within a week)

Study Sites (1)

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