Back to resultsEffect of Mirror Therapy on Unilateral Neglect for Patients After Stroke
Primary Purpose
The Effects of Mirror Therapy on Patients With Unilateral Neglect After Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mirror therapy
Sham mirror
Covered mirror
Sponsored by
About this trial
This is an interventional treatment trial for The Effects of Mirror Therapy on Patients With Unilateral Neglect After Stroke focused on measuring stroke; unilateral neglect; mirror therapy; mirror visual feedback
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Active Comparator
Arm Label
Mirror therapy
Sham mirror
Covered mirror
Arm Description
Outcomes
Primary Outcome Measures
Unilateral neglect
Behavioural Inattention Test
Allocentric and egocentric neglect
Gap Detection Test
Functional performance related to unilateral neglect
Catherine Bergego Scale
Secondary Outcome Measures
Upper limb functions
Fugl-Meyer assessment
Full Information
NCT ID
NCT03854487
First Posted
February 21, 2019
Last Updated
February 24, 2019
Sponsor
The Hong Kong Polytechnic University
Collaborators
Tung Wah Hospital, Guangdong 999 Brain Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03854487
Brief Title
Effect of Mirror Therapy on Unilateral Neglect for Patients After Stroke
Official Title
Effect of Mirror Therapy on Unilateral Neglect for Patients After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Tung Wah Hospital, Guangdong 999 Brain Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Effects of Mirror Therapy on Patients With Unilateral Neglect After Stroke
Keywords
stroke; unilateral neglect; mirror therapy; mirror visual feedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mirror therapy
Arm Type
Experimental
Arm Title
Sham mirror
Arm Type
Sham Comparator
Arm Title
Covered mirror
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mirror therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sham mirror
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Covered mirror
Intervention Description
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.
Primary Outcome Measure Information:
Title
Unilateral neglect
Description
Behavioural Inattention Test
Time Frame
Change of baseline to 3-week and to follow-up at 6-week
Title
Allocentric and egocentric neglect
Description
Gap Detection Test
Time Frame
Change of baseline to 3-week and to follow-up at 6-week
Title
Functional performance related to unilateral neglect
Description
Catherine Bergego Scale
Time Frame
Change of baseline to 3-week and to follow-up at 6-week
Secondary Outcome Measure Information:
Title
Upper limb functions
Description
Fugl-Meyer assessment
Time Frame
Change of baseline to 3-week and to follow-up at 6-week
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Male, Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34196963
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Mirror Therapy on Unilateral Neglect for Patients After Stroke
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