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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04242316
Other study ID # HSEARS20121012008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2014
Est. completion date January 1, 2019

Study information

Verified date January 2020
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date January 1, 2019
Est. primary completion date January 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Outcome

Type Measure Description Time frame Safety issue
Other Mu rhythm suppression generated in the sensorimotor cortex Electroencephalographical assessment for cortical activation induced by mirror visual feedback. Baseline
Other Mu rhythm suppression generated in the sensorimotor cortex Electroencephalographical assessment for cortical activation induced by mirror visual feedback. 6-week
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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