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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiplegia
• Intervention / Treatment: Behavioral: Mirror Therapy; Behavioral: Bilateral arm training

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	After 6-week
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.	3-month after the completion of training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	After 6-week
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.	3-month after the completion of training
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).	Baseline
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).	After 6-week
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).	3-month after the completion of training

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mu rhythm suppression generated in the sensorimotor cortex	Electroencephalographical assessment for cortical activation induced by mirror visual feedback.	Baseline
Mu rhythm suppression generated in the sensorimotor cortex	Electroencephalographical assessment for cortical activation induced by mirror visual feedback.	6-week

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Stroke; Upper limb function; Mirror therapy; Bilateral arm training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Hemiplegia
• Other Study ID Numbers: HSEARS20121012008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No