Clinical trial NCT03854487: 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
Overall status: COMPLETED
Phase: NA
Conditions: The Effects of Mirror Therapy on Patients With Unilateral Neglect After Stroke
Keywords: stroke; unilateral neglect; mirror therapy; mirror visual feedback
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Tung Wah Hospital
name: Guangdong 999 Brain Hospital
First posted: 2019-02-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Unilateral neglect
timeFrame: Change of baseline to 3-week and to follow-up at 6-week
measure: Allocentric and egocentric neglect
timeFrame: Change of baseline to 3-week and to follow-up at 6-week
measure: Functional performance related to unilateral neglect
timeFrame: Change of baseline to 3-week and to follow-up at 6-week
Secondary outcomes:
measure: Upper limb functions
timeFrame: Change of baseline to 3-week and to follow-up at 6-week
Other outcomes:
Locations:
Study officials:
References:
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.