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Completed

NCT Number: NCT04242316

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mirror Therapy

Behavioral

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

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Jan 27, 2020
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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