Clinical trial NCT06103045: The Effects of Unilateral and Bilateral Mirror Therapy on Upper Extremity Function of Stroke At Acute Stage.
Official title: The Effects of Unilateral and Bilateral Mirror Therapy on Upper Extremity Function of Stroke At Acute Stage: a Pilot Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute
Keywords: Stroke
unilateral mirror therapy
bilateral mirror therapy
acute stage
motor function of upper extremity
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Fugl-Meyer Assessment for upper extremity (FMA-UE)
timeFrame: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
measure: The Jamar Hydraulic Hand Dynamometer
timeFrame: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
measure: Chedoke Arm and Hand Activity Inventory (CAHAI)
timeFrame: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
measure: Functional Independence Measurement (FIM)
timeFrame: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
measure: Revised Nottingham Sensory Assessment (rNSA)
timeFrame: pre-treatment: before intervention within a week; post-treatment: after intervention within a week
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch
Study officials:
affiliation: National Taiwan University Hospital Hsin-Chu Branch
name: Chia-Yi Lin, MS
role: PRINCIPAL_INVESTIGATOR
References:
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