StrokeNCT04242316
Effects of Mirror Therapy and Bilateral Arm Training on Hemiparetic Upper Extremity in Patients With Chronic Stroke
A study testing Mirror Therapy and Bilateral arm training in people with Stroke and Hemiplegia, run by The Hong Kong Polytechnic University.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- Mirror Therapy and Bilateral arm training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals with severe neglect and severe spasticity (Modified Ashworth Scale >3) would be excluded.
About this study
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.
Read the 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.
- Conditions
- Stroke, Hemiplegia
- Being tested
- Mirror Therapy, Bilateral arm training
- Keywords
- Stroke, Mirror therapy, Bilateral arm training, Upper limb function
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror TherapyBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy | Experimental | 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. Receives: Behavioral: Mirror Therapy |
| Bilateral arm training | Active comparator | Patients performed customized bimanual upper limb exercises without a mirror. Receives: Behavioral: Bilateral arm training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3-month after the completion of training
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 3-month after the completion of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Jan 2014
- Primary completion1 Jan 2017
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242316
- Sponsor's protocol ID
- HSEARS20121012008
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mirror Therapy and Bilateral Arm Training on Hemiparetic Upper Extremity in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT04242316
- Acronym / sponsor ID
- HSEARS20121012008
- Conditions
- Stroke, Hemiplegia
- Keywords
- Stroke, Mirror therapy, Bilateral arm training, Upper limb function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy | Experimental | Behavioral: Mirror TherapyPatients performed customized bimanual upper limb exercises with a mirror. They can observe the mirror visual feedback of their non-paretic hand during the movements. |
| Bilateral arm training | Active comparator | Behavioral: Bilateral arm trainingPatients performed customized bimanual upper limb exercises without a mirror. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- Individuals with severe neglect and severe spasticity (Modified Ashworth Scale >3) would be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirror TherapyPatients 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. | Behavioural | Mirror Therapy |
| Bilateral arm trainingPatients 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. | Behavioural | Bilateral arm training |
Primary outcome
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.
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.
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.
6 secondary outcomes
Action Research Arm Test (ARAT)
Time frame: Baseline
Action Research Arm Test (ARAT)
Time frame: After 6-week
Action Research Arm Test (ARAT)
Time frame: 3-month after the completion of training
Wolf Motor Function Test (WMFT)
Time frame: Baseline
Wolf Motor Function Test (WMFT)
Time frame: After 6-week
Wolf Motor Function Test (WMFT)
Time frame: 3-month after the completion of training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy and Bilateral arm training in people with Stroke and Hemiplegia, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer assessment (FMA) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.