Condition category
Circulatory System
Date applied
18/11/2010
Date assigned
18/11/2010
Last edited
23/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Nessa Thomas

ORCID ID

Contact details

University of Salford
Centre for Rehabilitation and Human Performance Research
Allerton Building
Frederick Road
Salford
M6 6PU
United Kingdom
-
n.thomas@salford.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9353

Study information

Scientific title

Mirror Arm Exercises for STROke

Acronym

MAESTRO

Study hypothesis

A new technique, called mirror therapy, may improve the recovery of the upper limb. With this method, a mirror is placed alongside the 'good' arm so that the reflection looks as if the weak arm is moving. The patient moves both arms, as much as they can, while looking in the mirror. The appearance of both arms moving normally seems to strengthen the brain's attempts to 'rewire' the connections to produce movements of the weak limb. Ultimately we want to investigate whether mirror therapy works if used during stroke rehabilitation in a manner that is suitable for the NHS. Initially we want to test whether mirror therapy:
1. Is acceptable to patients and the clinical team
2. How much it is used by patients
3. Is practical to use in the NHS
4. Causes any side effects
5. Improves different types of problems such as weakness, numbness, awareness of the affected side, grips and grasps and use of the arm and hands

The results will also tell us how many patients we can recruit, how much therapy they are able to do and how variable their outcomes are; information that we will use in future studies.

Participants who are in a rehabilitation unit will be recruited at least 1 week after their stroke. They will be randomly divided to receive mirror or control therapy. The control treatment is exercises to the legs delivered in the same way as the mirror therapy (but with no mirror). Both groups will also receive usual treatment. Participants will aim to exercise for up to 30 minutes a day (in several sessions according to their ability and tolerance) for 4 weeks. We will assess how well the patient can move and use their weak arm and hand before and after the trial and again one month later. At the end of the treatment we will also assess how acceptable the patients and the clinical team found the therapy, how much the patients used the treatment and whether there were any side effects.

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised interventional phase II treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: In hospital study

Intervention

Participants in a rehabilitation unit are recruited at least 1 week after their stroke and are randomly divided to receive mirror or control therapy. The control treatment is exercises to the legs delivered in the same way as the mirror therapy (but with no mirror). Both groups will also receive usual treatment. Participants will aim to exercise for up to 30 minutes a day (in several sessions according to their ability and tolerance) for 4 weeks.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

How well the patient can move and use their weak arm and hand, measured at baseline, immediately after the trial, and one month after the trial

Secondary outcome measures

Measured at end of treatment:
1. Acceptability of therapy to patients and clinical team
2. How much the patients used the treatment
3. Side effects

Overall trial start date

03/01/2011

Overall trial end date

02/07/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. First time stroke at least 1 week previously and inpatient in a stroke rehabilitation unit
2. No premorbid conditions limiting upper limb function
3. Sufficient cognitive and communication skills to give consent (as judged by the clinical team)
4. Medically stable and able to participate in rehabilitation (as judged by the clinical team)
5. Upper limb weakness which limits activity (Motricity Index Upper Limb score less than 99)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 83

Participant exclusion criteria

1. Unable to consent
2. Not a first time stroke
3. Previous condition limiting upper limb function
4. Unable to participate in rehabilitation
5. No upper limb weakness

Recruitment start date

03/01/2011

Recruitment end date

02/07/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Salford
Salford
M6 6PU
United Kingdom

Sponsor information

Organisation

University of Salford (UK)

Sponsor details

Centre for Rehabilitation and Human Performance Research
Allerton Building
Frederick Road
Salford
M6 6PU
United Kingdom

Sponsor type

University/education

Website

http://www.salford.ac.uk/

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25873095

Publication citations

Additional files

Editorial Notes