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

Primary Purpose

Stroke, Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mirror Therapy
Bilateral arm training
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Mirror therapy, Bilateral arm training, Upper limb function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Mirror Therapy

    Bilateral arm training

    Arm Description

    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.

    Patients performed customized bimanual upper limb exercises without a mirror.

    Outcomes

    Primary Outcome Measures

    Fugl-Meyer assessment (FMA)
    FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.
    Fugl-Meyer assessment (FMA)
    FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.
    Fugl-Meyer assessment (FMA)
    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

    Action Research Arm Test (ARAT)
    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.
    Action Research Arm Test (ARAT)
    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.
    Action Research Arm Test (ARAT)
    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.
    Wolf Motor Function Test (WMFT)
    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).
    Wolf Motor Function Test (WMFT)
    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).
    Wolf Motor Function Test (WMFT)
    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).

    Full Information

    First Posted
    January 22, 2020
    Last Updated
    January 22, 2020
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04242316
    Brief Title
    Effects of Mirror Therapy and Bilateral Arm Training on Hemiparetic Upper Extremity in Patients With Chronic Stroke
    Official Title
    Effects of Mirror Therapy and Bilateral Arm Training on Hemiparetic Upper Extremity in Patients With Chronic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    January 1, 2017 (Actual)
    Study Completion Date
    January 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Hong Kong Polytechnic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Hemiplegia
    Keywords
    Stroke, Mirror therapy, Bilateral arm training, Upper limb function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    101 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mirror Therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Bilateral arm training
    Arm Type
    Active Comparator
    Arm Description
    Patients performed customized bimanual upper limb exercises without a mirror.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mirror Therapy
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Bilateral arm training
    Intervention Description
    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 Measure Information:
    Title
    Fugl-Meyer assessment (FMA)
    Description
    FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.
    Time Frame
    Baseline
    Title
    Fugl-Meyer assessment (FMA)
    Description
    FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.
    Time Frame
    After 6-week
    Title
    Fugl-Meyer assessment (FMA)
    Description
    FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.
    Time Frame
    3-month after the completion of training
    Secondary Outcome Measure Information:
    Title
    Action Research Arm Test (ARAT)
    Description
    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.
    Time Frame
    Baseline
    Title
    Action Research Arm Test (ARAT)
    Description
    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.
    Time Frame
    After 6-week
    Title
    Action Research Arm Test (ARAT)
    Description
    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.
    Time Frame
    3-month after the completion of training
    Title
    Wolf Motor Function Test (WMFT)
    Description
    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).
    Time Frame
    Baseline
    Title
    Wolf Motor Function Test (WMFT)
    Description
    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).
    Time Frame
    After 6-week
    Title
    Wolf Motor Function Test (WMFT)
    Description
    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).
    Time Frame
    3-month after the completion of training
    Other Pre-specified Outcome Measures:
    Title
    Mu rhythm suppression generated in the sensorimotor cortex
    Description
    Electroencephalographical assessment for cortical activation induced by mirror visual feedback.
    Time Frame
    Baseline
    Title
    Mu rhythm suppression generated in the sensorimotor cortex
    Description
    Electroencephalographical assessment for cortical activation induced by mirror visual feedback.
    Time Frame
    6-week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: neurological condition with unilateral hemiparesis; a Functional Test of Hemiplegic Upper Extremity (FTHUE) score between levels 2 to 6; chronic stroke with onset of neurological condition more than 6 months previously; ability to understand and follow simple verbal instructions; ability to participate in a therapy session lasting at least 30 minutes; community ambulant with or without aids. Exclusion Criteria: Individuals with severe neglect and severe spasticity (Modified Ashworth Scale >3) would be excluded.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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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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