NCT03854487

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

February 21, 2019

Last Update Submit

February 24, 2019

Conditions

Keywords

stroke; unilateral neglect; mirror therapy; mirror visual feedback

Outcome Measures

Primary Outcomes (3)

  • Unilateral neglect

    Behavioural Inattention Test

    Change of baseline to 3-week and to follow-up at 6-week

  • Allocentric and egocentric neglect

    Gap Detection Test

    Change of baseline to 3-week and to follow-up at 6-week

  • Functional performance related to unilateral neglect

    Catherine Bergego Scale

    Change of baseline to 3-week and to follow-up at 6-week

Secondary Outcomes (1)

  • Upper limb functions

    Change of baseline to 3-week and to follow-up at 6-week

Study Arms (3)

Mirror therapy

EXPERIMENTAL
Behavioral: Mirror therapy

Sham mirror

SHAM COMPARATOR
Behavioral: Sham mirror

Covered mirror

ACTIVE COMPARATOR
Behavioral: Covered mirror

Interventions

Mirror therapyBEHAVIORAL

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.

Mirror therapy
Sham mirrorBEHAVIORAL

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.

Sham mirror
Covered mirrorBEHAVIORAL

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.

Covered mirror

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale, Female
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 26, 2019

Study Start

July 1, 2016

Primary Completion

September 30, 2017

Study Completion

June 30, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share