Mirror Arm Exercises for STROke

ISRCTN	ISRCTN29533052
DOI	https://doi.org/10.1186/ISRCTN29533052
Secondary identifying numbers	9353

Submission date: 18/11/2010
Registration date: 18/11/2010
Last edited: 23/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Miss Nessa Thomas
Scientific

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

Email	n.thomas@salford.ac.uk

Study information

Study design	Multicentre randomised interventional phase II treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Mirror Arm Exercises for STROke
Study 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(s)	Not provided at time of registration
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
Primary outcome measure	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 study start date	03/01/2011
Overall study end date	02/07/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned sample size: 83
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 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

England
United Kingdom

Study participating centre

University of Salford

Salford
M6 6PU
United Kingdom

Sponsor information

University of Salford (UK)
University/education

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

Website	http://www.salford.ac.uk/
"ROR"	https://ror.org/01tmqtf75

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	07/04/2015		Yes	No