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
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
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.
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
NCT ID
NCT04242316
First Posted
January 22, 2020
Last Updated
January 22, 2020
Sponsor
The Hong Kong Polytechnic University
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
Learn more about this trial
Effects of Mirror Therapy and Bilateral Arm Training on Hemiparetic Upper Extremity in Patients With Chronic Stroke
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