|
ISRCTN
|
ISRCTN29533052
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Mirror Arm Exercises for STROke
|
|
Scientific title
|
|
|
Acronym
|
MAESTRO
|
|
Serial number at source
|
9353
|
|
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.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Multicentre randomised interventional phase II treatment trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: In hospital study
|
|
Participants - 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)
|
|
Participants - 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
|
|
Anticipated start date
|
03/01/2011
|
|
Anticipated end date
|
02/07/2012
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
|
|
Target number of participants
|
Planned sample size: 83
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
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
|
|
Sources of funding
|
National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Miss
Nessa
Thomas
|
|
Address
|
University of Salford
Centre for Rehabilitation and Human Performance Research
Allerton Building
Frederick Road
|
|
City/town
|
Salford
|
|
Zip/Postcode
|
M6 6PU
|
|
Country
|
United Kingdom
|
|
Email
|
n.thomas@salford.ac.uk
|
|
Sponsor
|
University of Salford (UK)
|
|
Address
|
Centre for Rehabilitation and Human Performance Research
Allerton Building
Frederick Road
|
|
City/town
|
Salford
|
|
Zip/Postcode
|
M6 6PU
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.salford.ac.uk/
|
|
Date applied
|
18/11/2010
|
|
Last edited
|
18/11/2010
|
|
Date ISRCTN assigned
|
18/11/2010
|
