Effect of Mirror Therapy on Unilateral Neglect for Patients After Stroke

NCT ID: NCT03854487

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2018-06-30

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.

Conditions

The Effects of Mirror Therapy on Patients With Unilateral Neglect After Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mirror therapy

Group Type: EXPERIMENTAL

Mirror therapy

Intervention Type: BEHAVIORAL

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 mirror

Group Type: SHAM_COMPARATOR

Sham mirror

Intervention Type: BEHAVIORAL

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 mirror

Group Type: ACTIVE_COMPARATOR

Covered mirror

Intervention Type: BEHAVIORAL

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.

Interventions

Mirror therapy

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

Sham mirror

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

Covered mirror

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tung Wah Hospital

OTHER

Sponsor Role: collaborator

Guangdong 999 Brain Hospital

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 34196963 (View on PubMed)

Other Identifiers

BQ46L

Identifier Type: -

Identifier Source: org_study_id