The Effects of Mirror Therapy on Patients With Unilateral Neglect After StrokeNCT03854487
Effect of Mirror Therapy on Unilateral Neglect for Patients After Stroke
A study testing Mirror therapy and Covered mirror in people with The Effects of Mirror Therapy on Patients With Unilateral Neglect After Stroke, run by The Hong Kong Polytechnic University.
Trial summary
This is a single-blinded randomized controlled trial to investigate the effects of mirror therapy (MT), with reference to sham mirror (a glass wall) and control (a covered mirror), in reducing unilateral neglect for patients with stroke in 2 centres. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Effects of Mirror Therapy on Patients With Unilateral Neglect After Stroke
- What is being tested?
- Mirror therapy and Covered mirror
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 30 Jun 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic or hemorrhagic stroke, confirmed by medical diagnoses compatible with a unilateral right lesion involvement (i.e. left hemiplegic), exhibited left visual field inattention or unilateral neglect by obtaining a total score of star cancellation subtest in the conventional battery of the Behavioural Inattention Test ≤ 51 (out of 54);
- stroke with onset of neurological condition ≤ 6 months previously;
- have normal or corrected-to-normal visual acuity better than 20/60 (6/18) in the better eye;
- with hemiplegic upper extremity functional levels 3-7 as rated by Functional Test for the Hemiplegic Upper Extremity and is able to move against gravity;
- ability to understand and follow simple verbal instructions, with Mini-mental State Examination ≥ 21;
- ability to participate in a therapy session lasting at least 30 minutes;
- consent to participant in the study
Who cannot join
- prior neurological or psychiatric disorders;
- severe spasticity (Modified Ashworth Scale >3) over paretic arm;
- history of recent Botox injection or acupuncture to the paretic arm within the past three months;
- participation in another clinical study elsewhere apart from the study site during recruitment
About this study
This is a single-blinded randomized controlled trial to investigate the effects of mirror therapy (MT), with reference to sham mirror (a glass wall) and control (a covered mirror), in reducing unilateral neglect for patients with stroke in 2 centres.
Read the detailed description
Twenty-one subacute inpatients with left unilateral neglect after right-hemispheric stroke, recruited from 2 hospitals - Hong Kong and Guangzhou, in 1 and a half years, were randomly assigned to three groups; mirror therapy, sham therapy (in the form of a transparent glass wall), and control (covered mirror). The treatment programme for all groups consisted of 12 sessions (4 per week for 3 weeks) movement practice for the hemiplegic arm involved 5 table-top tasks graded according to the severity of patients' arm impairments. Blinded assessments were administered at baseline, 3-week postintervention, and 3-week follow-up upon completion of training.
- Being tested
- Mirror therapy, Sham mirror, Covered mirror
- Keywords
- stroke; unilateral neglect; mirror therapy; mirror visual feedback
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror therapyBehavioural
A mirror is placed at the midsagittal plane of the patient. The patients in the mirror therapy group watched the mirror illusion of the non-affected arm in the mirror and moved together with the affected arm. The treatment programme for all groups consisted of 12 sessions (4 per week for 3 weeks), each lasting for 30 minutes. The movement practice involved 5 table-top tasks and the patient was instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session. Treatment activities are graded according to the severity of the patient's upper extremity impairment.
Sham mirrorBehavioural
A transparent glass wall is placed at the midsagittal plane of the patient. The patients in the sham mirror group watched the movements of the affected arm through the transparent glass wall and moved together with the non-affected arm. The treatment programme for all groups consisted of 12 sessions (4 per week for 3 weeks), each lasting for 30 minutes. The movement practice involved 5 table-top tasks and the patient was instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session. Treatment activities are graded according to the severity of the patient's upper extremity impairment.
Covered mirrorBehavioural
A covered mirror is placed at the midsagittal plane of the patient. The patients in the control group watched the movements of the non-affected arm and moved together with the affected arm behind the covered mirror. The treatment programme for all groups consisted of 12 sessions (4 per week for 3 weeks), each lasting for 30 minutes. The movement practice involved 5 table-top tasks and the patient was instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session. Treatment activities are graded according to the severity of the patient's upper extremity impairment.
| Study group | Role | What they receive |
|---|---|---|
| Mirror therapy | Experimental | Not described Receives: Behavioral: Mirror therapy |
| Sham mirror | Sham comparator | Not described Receives: Behavioral: Sham mirror |
| Covered mirror | Active comparator | Not described Receives: Behavioral: Covered mirror |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unilateral neglect
Behavioural Inattention Test
Measured: Change of baseline to 3-week and to follow-up at 6-week
Allocentric and egocentric neglect
Gap Detection Test
Measured: Change of baseline to 3-week and to follow-up at 6-week
Functional performance related to unilateral neglect
Catherine Bergego Scale
Measured: Change of baseline to 3-week and to follow-up at 6-week
Secondary outcomes (1)
Upper limb functions
Fugl-Meyer assessment
Measured: Change of baseline to 3-week and to follow-up at 6-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 Jul 2016
- Primary completion30 Sep 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Effects of Mirror Therapy on Patients With Unilateral Neglect After 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Tung Wah Hospital, Guangdong 999 Brain Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854487
- Sponsor's protocol ID
- BQ46L
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
PubMed 34196963
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mirror Therapy on Unilateral Neglect for Patients After Stroke
- ClinicalTrials.gov ID
- NCT03854487
- Acronym / sponsor ID
- BQ46L
- Keywords
- stroke; unilateral neglect; mirror therapy; mirror visual feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Tung Wah Hospital, Guangdong 999 Brain Hospital
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 26 Feb 2019 (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 is a single-blinded randomized controlled trial to investigate the effects of mirror therapy (MT), with reference to sham mirror (a glass wall) and control (a covered mirror), in reducing unilateral neglect for patients with stroke in 2 centres.
Detailed description
Twenty-one subacute inpatients with left unilateral neglect after right-hemispheric stroke, recruited from 2 hospitals - Hong Kong and Guangzhou, in 1 and a half years, were randomly assigned to three groups; mirror therapy, sham therapy (in the form of a transparent glass wall), and control (covered mirror). The treatment programme for all groups consisted of 12 sessions (4 per week for 3 weeks) movement practice for the hemiplegic arm involved 5 table-top tasks graded according to the severity of patients' arm impairments. Blinded assessments were administered at baseline, 3-week postintervention, and 3-week follow-up upon completion of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mirror therapy | Experimental | Behavioral: Mirror therapy |
| Sham mirror | Sham comparator | Behavioral: Sham mirror |
| Covered mirror | Active comparator | Behavioral: Covered mirror |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ischemic or hemorrhagic stroke, confirmed by medical diagnoses compatible with a unilateral right lesion involvement (i.e. left hemiplegic), exhibited left visual field inattention or unilateral neglect by obtaining a total score of star cancellation subtest in the conventional battery of the Behavioural Inattention Test ≤ 51 (out of 54);
- stroke with onset of neurological condition ≤ 6 months previously;
- have normal or corrected-to-normal visual acuity better than 20/60 (6/18) in the better eye;
- with hemiplegic upper extremity functional levels 3-7 as rated by Functional Test for the Hemiplegic Upper Extremity and is able to move against gravity;
- ability to understand and follow simple verbal instructions, with Mini-mental State Examination ≥ 21;
Key exclusion criteria (4 listed)
- prior neurological or psychiatric disorders;
- severe spasticity (Modified Ashworth Scale >3) over paretic arm;
- history of recent Botox injection or acupuncture to the paretic arm within the past three months;
- participation in another clinical study elsewhere apart from the study site during recruitment
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 therapyA mirror is placed at the midsagittal plane of the patient. The patients in the mirror therapy group watched the mirror illusion of the non-affected arm in the mirror and moved together with the affected arm. The treatment programme for all groups consisted of 12 sessions (4 per week for 3 weeks), each lasting for 30 minutes. The movement practice involved 5 table-top tasks and the patient was instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session. Treatment activities are graded according to the severity of the patient's upper extremity impairment. | Behavioural | Mirror therapy |
| Sham mirrorA transparent glass wall is placed at the midsagittal plane of the patient. The patients in the sham mirror group watched the movements of the affected arm through the transparent glass wall and moved together with the non-affected arm. The treatment programme for all groups consisted of 12 sessions (4 per week for 3 weeks), each lasting for 30 minutes. The movement practice involved 5 table-top tasks and the patient was instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session. Treatment activities are graded according to the severity of the patient's upper extremity impairment. | Behavioural | Sham mirror |
| Covered mirrorA covered mirror is placed at the midsagittal plane of the patient. The patients in the control group watched the movements of the non-affected arm and moved together with the affected arm behind the covered mirror. The treatment programme for all groups consisted of 12 sessions (4 per week for 3 weeks), each lasting for 30 minutes. The movement practice involved 5 table-top tasks and the patient was instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session. Treatment activities are graded according to the severity of the patient's upper extremity impairment. | Behavioural | Covered mirror |
Primary outcome
Unilateral neglect
Time frame: Change of baseline to 3-week and to follow-up at 6-week
Behavioural Inattention Test
Allocentric and egocentric neglect
Time frame: Change of baseline to 3-week and to follow-up at 6-week
Gap Detection Test
Functional performance related to unilateral neglect
Time frame: Change of baseline to 3-week and to follow-up at 6-week
Catherine Bergego Scale
1 secondary outcome
Upper limb functions
Time frame: Change of baseline to 3-week and to follow-up at 6-week
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 26 Feb 2019.
- Derived from this study: PubMed 34196963Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
- Individual participant dataSharing planned: No
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 Covered mirror in people with The Effects of Mirror Therapy on Patients With Unilateral Neglect After 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 7 inclusion and 4 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 26 Feb 2019. 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?
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?
Unilateral neglect (time frame: Change of baseline to 3-week and to follow-up at 6-week). 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?
On the ClinicalTrials.gov record for NCT03854487, which also lists 1 linked publication.
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 26 Feb 2019.