StrokeNCT04749199
Enhanced Mirror Therapy for Improving Brain Reorganization and Function in Stroke
A study testing Enhanced mirror therapy and Standard mirror therapy in people with Stroke, run by The Hong Kong Polytechnic University.
Trial summary
This research aims to test the methodological procedures and obtain preliminary results regarding the therapeutic and cost-effectiveness of enhanced mirror therapy relative to standard mirror therapy for improving brain reorganization and upper limb function in individuals with stroke. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Enhanced mirror therapy and Standard mirror therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Nov 2022
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults with stroke (40-75 years old), with normal or corrected-to-normal vision and hearing;
- post-stroke duration of ≥ 6 months, before the start of data collection;
- no severe deficits in memory, communication, or the ability to understand verbal instructions.
Who cannot join
- participants with recurrent stroke; and
- those who score < 24 on the Mini-Mental State Examination (MMSE).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Enhanced Mirror Therapy for Improving Brain Reorganization and Function in Stroke: A Pilot Randomized Controlled Trial With Economic Evaluation
This research aims to test the methodological procedures and obtain preliminary results regarding the therapeutic and cost-effectiveness of enhanced mirror therapy relative to standard mirror therapy for improving brain reorganization and upper limb function in individuals with stroke.
Read the detailed description
Stroke is among the leading causes of mortality and disability, worldwide. Muscle weakness and other complications associated with stroke can result in decreased quality of life and significant declines in the activities of daily living. Mirror therapy has been shown to have a moderate effect, facilitating the functional recovery among individuals who have experienced a stroke. A prototype for a computerized, mirror therapy device was developed and found to be feasible. Recently, the investigators published a critical review and an activation likelihood estimation (ALE) meta-analysis analysing the widespread reports of brain activity associated with mirror therapy. Observations using functional near-infrared spectroscopy (fNIRS) to evaluate a group of people with stroke (n = 14) and healthy volunteers (n = 18) revealed that performing complex tasks during the mirror therapy paradigm enhanced top-down motor facilitation in the ipsilesional/ipsilateral hemisphere relative to the moving limb. An important next step in this series of studies is to evaluate the training effects associated with the performance of complex tasks during mirror therapy among stroke patients, using the designed computerized mirror therapy device to deliver the enhanced mirror therapy training. The results of this study will help the investigators to understand the underlying mechanisms through which mirror therapy facilitates motor rehabilitation and will add to the body of literature describing the best, evidence-based practices for mirror therapy during stroke rehabilitation. The investigators propose a pilot study (n = 30) to test the methodological procedures and obtain preliminary results for a fully powered, randomized, controlled trial (RCT), combined with economic evaluation, to compare the therapeutic and cost-effectiveness between standard mirror therapy and enhanced (complex task and blurred image) mirror therapy.
- Conditions
- Stroke
- Being tested
- Enhanced mirror therapy, Standard mirror therapy
- Keywords
- Mirror therapy, Stroke, Hand function, Cost-effectiveness
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced mirror therapyBehavioural
Also called Complex task mirror therapy
Participants of the enhanced mirror therapy group will perform complex, randomized, finger opposition and reposition movements, using the thumb, index, middle, ring, and little fingers, and will be shown a 35% blurred visual feedback through the computerized mirror therapy device. Each participant will receive a mirror training session for 60 minutes each day, three times per week for four consecutive weeks.
Standard mirror therapyBehavioural
Also called Simple task mirror therapy
Participants allocated to this group will perform simple, sequential finger opposition and reposition movements, using the thumb, index, middle, ring, and little fingers, and will be shown a clear image of the exercising hand. Each participant will receive a mirror training session for 60 minutes each day, three times per week for four consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced mirror therapy group | Experimental | Participants in this group will perform complex and randomized finger opposition and reposition movements based on the training protocol, along with enhanced complexity and altered clarity of the displayed image. Receives: Behavioral: Enhanced mirror therapy |
| Standard mirror therapy group | Sham comparator | Participants in this group will perform simple and sequential finger opposition and reposition movements, along with a clear image showing the exercising hand of the participants. Receives: Behavioral: Standard mirror therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygenated haemoglobin concentrations
Functional near-infrared spectroscopy (fNIRS) will be used to assess neurovascular changes (blood oxygenated haemoglobin concentrations) in the M1. Higher the score obtained indicate better facilitation of the primary motor cortex.
Measured: Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)
Secondary outcomes (3)
Wrist and hand function
The Fugl-Meyer assessment (wrist and hand subcomponents) for the assessment of the upper limb function. The scale has a maximum score of 66 and a minimum of 34 with higher the score obtained better the wrist and hand function.
Measured: Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)
Upper limb function
The Action Research Arm Test (ARAT), to assess upper-limb function. The ARAT scores range from 0-57, with a maximum score of 57 points indicating better performance of the upper limb.
Measured: Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)
Economic evaluation
The Euro quality of life (EuroQol, 5 dimensions and 5 levels 62) survey, will assess the quality-adjusted life years (QALY) for the cost-effectiveness estimation. The EQ-5D-5L response will be converted into utility scores, which will be used to estimate gains or losses in quality-adjusted life-years (QALYs) over the follow-up period. The higher the score obtained better the quality-life-adjusted-years due to the intervention.
Measured: Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Nov 2022 (estimated)
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.
- 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
- Model description
- A blinded assessor and statistician will evaluate a two-arm, parallel-group, RCT that compares enhanced mirror therapy, comprised of increased task complexity and mirror image blurriness, with standard mirror therapy training among 30 participants with chronic stroke.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Canterbury, National University of Singapore
- Responsible party
- Principal investigator, Stanley John Winser, The Hong Kong Polytechnic University
- Investigators
- Stanley John Winser, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749199
- Sponsor's protocol ID
- MT-fNIRSstudy
- Status last verified
- Feb 2021
- First submitted
- 3 Dec 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Mirror Therapy for Improving Brain Reorganization and Function in Stroke: A Pilot Randomized Controlled Trial With Economic Evaluation
- ClinicalTrials.gov ID
- NCT04749199
- Acronym / sponsor ID
- MT-fNIRSstudy
- Conditions
- Stroke
- Keywords
- Mirror therapy, Stroke, Hand function, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- University of Canterbury, National University of Singapore
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 11 Feb 2021 (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.
This research aims to test the methodological procedures and obtain preliminary results regarding the therapeutic and cost-effectiveness of enhanced mirror therapy relative to standard mirror therapy for improving brain reorganization and upper limb function in individuals with stroke.
Detailed description
Stroke is among the leading causes of mortality and disability, worldwide. Muscle weakness and other complications associated with stroke can result in decreased quality of life and significant declines in the activities of daily living. Mirror therapy has been shown to have a moderate effect, facilitating the functional recovery among individuals who have experienced a stroke. A prototype for a computerized, mirror therapy device was developed and found to be feasible. Recently, the investigators published a critical review and an activation likelihood estimation (ALE) meta-analysis analysing the widespread reports of brain activity associated with mirror therapy. Observations using functional near-infrared spectroscopy (fNIRS) to evaluate a group of people with stroke (n = 14) and healthy volunteers (n = 18) revealed that performing complex tasks during the mirror therapy paradigm enhanced top-down motor facilitation in the ipsilesional/ipsilateral hemisphere relative to the moving limb. An important next step in this series of studies is to evaluate the training effects associated with the performance of complex tasks during mirror therapy among stroke patients, using the designed computerized mirror therapy device to deliver the enhanced mirror therapy training. The results of this study will help the investigators to understand the underlying mechanisms through which mirror therapy facilitates motor rehabilitation and will add to the body of literature describing the best, evidence-based practices for mirror therapy during stroke rehabilitation. The investigators propose a pilot study (n = 30) to test the methodological procedures and obtain preliminary results for a fully powered, randomized, controlled trial (RCT), combined with economic evaluation, to compare the therapeutic and cost-effectiveness between standard mirror therapy and enhanced (complex task and blurred image) mirror therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A blinded assessor and statistician will evaluate a two-arm, parallel-group, RCT that compares enhanced mirror therapy, comprised of increased task complexity and mirror image blurriness, with standard mirror therapy training among 30 participants with chronic stroke.
| Arm | Type | Receives |
|---|---|---|
| Enhanced mirror therapy group | Experimental | Behavioral: Enhanced mirror therapyParticipants in this group will perform complex and randomized finger opposition and reposition movements based on the training protocol, along with enhanced complexity and altered clarity of the displayed image. |
| Standard mirror therapy group | Sham comparator | Behavioral: Standard mirror therapyParticipants in this group will perform simple and sequential finger opposition and reposition movements, along with a clear image showing the exercising hand of the participants. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults with stroke (40-75 years old), with normal or corrected-to-normal vision and hearing;
- post-stroke duration of ≥ 6 months, before the start of data collection;
- no severe deficits in memory, communication, or the ability to understand verbal instructions.
Key exclusion criteria (2 listed)
- participants with recurrent stroke; and
- those who score < 24 on the Mini-Mental State Examination (MMSE).
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 |
|---|---|---|
| Enhanced mirror therapyAlso: Complex task mirror therapyParticipants of the enhanced mirror therapy group will perform complex, randomized, finger opposition and reposition movements, using the thumb, index, middle, ring, and little fingers, and will be shown a 35% blurred visual feedback through the computerized mirror therapy device. Each participant will receive a mirror training session for 60 minutes each day, three times per week for four consecutive weeks. | Behavioural | Enhanced mirror therapy group |
| Standard mirror therapyAlso: Simple task mirror therapyParticipants allocated to this group will perform simple, sequential finger opposition and reposition movements, using the thumb, index, middle, ring, and little fingers, and will be shown a clear image of the exercising hand. Each participant will receive a mirror training session for 60 minutes each day, three times per week for four consecutive weeks. | Behavioural | Standard mirror therapy group |
Primary outcome
Blood oxygenated haemoglobin concentrations
Time frame: Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)
Functional near-infrared spectroscopy (fNIRS) will be used to assess neurovascular changes (blood oxygenated haemoglobin concentrations) in the M1. Higher the score obtained indicate better facilitation of the primary motor cortex.
3 secondary outcomes
Wrist and hand function
Time frame: Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)
Upper limb function
Time frame: Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)
Economic evaluation
Time frame: Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
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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.
Stanley John Winser principal investigator
The Hong Kong Polytechnic University
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced mirror therapy and Standard mirror therapy in people with Stroke, 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Feb 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stanley John Winser (27666746, stanley.j.winser@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood oxygenated haemoglobin concentrations (time frame: Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)). 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 15 Feb 2021.