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Effects of Mirror Therapy and Bilateral Arm Training on Hemiparetic Upper Extremity in Patients With Chronic Stroke

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ClinicalTrials.gov Identifier: NCT04242316
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
The Hong Kong Polytechnic University

Brief Summary:
The aim of this study included (1) to compare the effectiveness of mirror therapy (MT) and bimanual arm training (BAT) in improving motor and functional performance of hemiplegic upper extremity for adults with chronic stroke; (2) to examine whether recruitment of the mirror neurons, as reflected in mu rhythm suppression, mediates recognition of the mirror illusion in pre/post MT, as compared to BAT without a mirror in clients with chronic stroke, as compared to healthy participants.

Condition or disease Intervention/treatment Phase
Stroke Hemiplegia Behavioral: Mirror Therapy Behavioral: Bilateral arm training Not Applicable

Detailed Description:
Mirror Therapy (MT) appeared to have beneficial effects on the recovery of distal function of the hemiplegic hand in the evidence recently, however, it is not known whether the incongruent visual feedback induced by mirror in bilateral arm training (BAT) is beneficial to the motor performance of upper extremity than without the mirror in patients with chronic stroke. This study aimed to compare the effectiveness of MT and bimanual arm training (BAT) in improving motor and functional performance of hemiplegic upper extremity for adults with chronic stroke. Participants with chronic stroke were recruited by convenience sampling from a convalescent hospital and self-help groups in the community in Hong Kong. Participants were randomly assigned to the MT group or BAT group and participated in a 6-week upper limb training programme which consisted of two 45-minute training sessions per week. Both kinds of training were equivalent to each other except that there was a mirror used in the MT group. Main outcome measures were upper extremity motor and functional tests, and grip strength. Participants were evaluated at baseline, post-treatment and 3-month follow-up. EEG was assessed before and after the training in a group of stroke patients and healthy controls, in order to evaluate the recruitment of the mirror neurons, as reflected in mu rhythm suppression.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Mirror Therapy and Bilateral Arm Training on Hemiparetic Upper Extremity in Patients With Chronic Stroke
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : January 1, 2019

Arm Intervention/treatment
Experimental: Mirror Therapy
Patients performed customized bimanual upper limb exercises with a mirror. They can observe the mirror visual feedback of their non-paretic hand during the movements.
Behavioral: Mirror Therapy
Patients performed customized bimanual upper limb exercises with graded level of difficulty based on the patient's individual levels of upper limb functioning according to the 7 levels of the FTHUE and each level consisted of 5 standardized table-top tasks. The patients practiced the movements with the unaffected hand (including the shoulder, elbow, wrist, and hand). While watching the reflection of the unaffected hand in the mirror, the patient was then asked to moving the affected hand at the same time to synchronize the movement with the reflection of the unaffected hand. If the patient was unable to move the hand, a therapist would passively assist the movement of the affected hand so as to synchronize it with the reflection of the unaffected hand.

Active Comparator: Bilateral arm training
Patients performed customized bimanual upper limb exercises without a mirror.
Behavioral: Bilateral arm training
Patients performed customized bimanual upper limb exercises with graded level of difficulty based on the patient's individual levels of upper limb functioning according to the 7 levels of the FTHUE and each level consisted of 5 standardized table-top tasks, but without a mirror. The patients can take a direct view of their paretic hand.




Primary Outcome Measures :
  1. Fugl-Meyer assessment (FMA) [ Time Frame: Baseline ]
    FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.

  2. Fugl-Meyer assessment (FMA) [ Time Frame: After 6-week ]
    FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.

  3. Fugl-Meyer assessment (FMA) [ Time Frame: 3-month after the completion of training ]
    FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.


Secondary Outcome Measures :
  1. Action Research Arm Test (ARAT) [ Time Frame: Baseline ]
    ARAT is a standard upper limb functional performance assessment for stroke survivors. ARAT assesses a patient's ability to handle objects differing in size, weight and shape. ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement.

  2. Action Research Arm Test (ARAT) [ Time Frame: After 6-week ]
    ARAT is a standard upper limb functional performance assessment for stroke survivors. ARAT assesses a patient's ability to handle objects differing in size, weight and shape. ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement.

  3. Action Research Arm Test (ARAT) [ Time Frame: 3-month after the completion of training ]
    ARAT is a standard upper limb functional performance assessment for stroke survivors. ARAT assesses a patient's ability to handle objects differing in size, weight and shape. ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement.

  4. Wolf Motor Function Test (WMFT) [ Time Frame: Baseline ]
    WMFT assesses the functional limitation of upper limb after a neurological condition. This test evaluates both strength (2 items) and function-based task performance (15 items).

  5. Wolf Motor Function Test (WMFT) [ Time Frame: After 6-week ]
    WMFT assesses the functional limitation of upper limb after a neurological condition. This test evaluates both strength (2 items) and function-based task performance (15 items).

  6. Wolf Motor Function Test (WMFT) [ Time Frame: 3-month after the completion of training ]
    WMFT assesses the functional limitation of upper limb after a neurological condition. This test evaluates both strength (2 items) and function-based task performance (15 items).


Other Outcome Measures:
  1. Mu rhythm suppression generated in the sensorimotor cortex [ Time Frame: Baseline ]
    Electroencephalographical assessment for cortical activation induced by mirror visual feedback.

  2. Mu rhythm suppression generated in the sensorimotor cortex [ Time Frame: 6-week ]
    Electroencephalographical assessment for cortical activation induced by mirror visual feedback.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. neurological condition with unilateral hemiparesis;
  2. a Functional Test of Hemiplegic Upper Extremity (FTHUE) score between levels 2 to 6;
  3. chronic stroke with onset of neurological condition more than 6 months previously;
  4. ability to understand and follow simple verbal instructions;
  5. ability to participate in a therapy session lasting at least 30 minutes;
  6. community ambulant with or without aids.

Exclusion Criteria:

Individuals with severe neglect and severe spasticity (Modified Ashworth Scale >3) would be excluded.

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Responsible Party: The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT04242316    
Other Study ID Numbers: HSEARS20121012008
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Hong Kong Polytechnic University:
Stroke
Mirror therapy
Bilateral arm training
Upper limb function
Additional relevant MeSH terms:
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Stroke
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms