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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03854487
Other study ID # BQ46L
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2016
Est. completion date June 30, 2018

Study information

Verified date February 2019
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date June 30, 2018
Est. primary completion date September 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

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

Intervention

Behavioral:
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.
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.
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University Guangdong 999 Brain Hospital, Tung Wah Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Unilateral neglect Behavioural Inattention Test Change of baseline to 3-week and to follow-up at 6-week
Primary Allocentric and egocentric neglect Gap Detection Test Change of baseline to 3-week and to follow-up at 6-week
Primary Functional performance related to unilateral neglect Catherine Bergego Scale Change of baseline to 3-week and to follow-up at 6-week
Secondary Upper limb functions Fugl-Meyer assessment Change of baseline to 3-week and to follow-up at 6-week