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ISRCTN
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ISRCTN03624752
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ClinicalTrials.gov identifier
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Public title
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Predicting Outcome and Measuring Benefit from botulinum therapy in Stroke
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Scientific title
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A single centre randomised interventional treatment trial of botulinum toxin-A versus placebo in the improvement of active function in upper limb disability of stroke survivors
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Acronym
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PrOMBiS
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Serial number at source
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5644
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Study hypothesis
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Upper limb disability is a major problem for many stroke survivors; clinical and experimental observation suggests that disordered grasp release is a significant contributory factor. This study will investigate whether botulinum toxin-A improves active function in the impaired limb. Previous studies have shown passive improvement in tone, but functional benefit has not been convincingly or consistently demonstrated. This may be due to limitations in functional outcome measures and inaccurate selection of participants. We will use novel and unique outcome measures that will 1) objectively measure a functionally relevant grasp release task, and 2) use a gold standard measure of spasticity (our customised servomotor) to accurately predict who will benefit from treatment (and compare this to conventional portable EMG studies).
We will carry out a double-blind RCT with subjects (n=30) more than 3 months post-stroke, randomised to treatment or placebo group. Participants will be given injections (toxin or placebo) followed by standardised, effective upper-limb physiotherapy. The study is powered to detect between-group differences in grasp release.
This study will indicate whether active functional benefit results from treatment with botulinum toxin and physiotherapy, and will guide the accurate selection of participants likely to benefit both in clinical practice and future intervention trials.
As of 25/08/2011 the end date for this trial has been extended from 29/01/2011 to 31/12/2012.
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Lay summary
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Lay summary under review
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Ethics approval
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UCLH Research Ethics Committee A approved on the 7th April 2009 (ref: 09/H0714/5)
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Study design
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Single centre randomised interventional treatment trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Drug type, Therapy type, In hospital study
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Participants - inclusion criteria
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1. Clinically confirmed diagnosis of stroke
2. More than 1 month post-stroke
3. An Ashworth score of 2 or more
4. The ability to pick up a mug and move it to another position (so that participants are able to use any improvement in hand control in functional reach and grasp tasks)
5. Aged 18 years and over (no max), both male and female participants
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Participants - exclusion criteria
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1. Orthopaedic impairments affecting the hemiplegic upper limb or spine
2. Additional neurological impairment not related to stroke
3. Shoulder or wrist pain (greater than 3 on a 0 - 10 visual analogue scale) whilst performing the experimental tasks
4. Severe cognitive impairment preventing informed consent and/or the ability to follow task instructions
5. Anti-coagulation with an international normalised ratio (INR) of greater than 2
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Anticipated start date
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03/07/2009
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Anticipated end date
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31/12/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 30; UK sample size: 30
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Interventions
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Injections of investigative medical product (IMP) or placebo followed by 10 sessions of standardised physiotherapy.
Follow up length: 6 months
Study entry: single randomisation only
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Primary outcome measure(s)
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The functional grasp release task at baseline, 1 month and 3 months
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Secondary outcome measure(s)
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1. 9-Hole peg test
2. Action Research Arm Test
3. Arm Activity Measure
4. EQ-5D
5. Goal Attainment Score
6. Measure of Muscle Stiffness and Spasticity
7. Muscle strength
Measured at baseline, immediately after treatment, at one month and at 3 months plus a further 6 month follow up just with the questionnaires by post.
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Sources of funding
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The Stroke Association (UK)
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Trial website
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Publications
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Contact name
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Ms
Luci
Crook
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Address
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Institute of Neurology
Queen Square
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City/town
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London
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Zip/Postcode
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WC1N 3BG
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Country
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United Kingdom
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Sponsor
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University College London (UK)
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Address
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The National Hospital for Neurology and Neurosurgery
Queen Square
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City/town
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London
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Zip/Postcode
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WC1N 3BG
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Country
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United Kingdom
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Sponsor website:
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http://www.ucl.ac.uk
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Date applied
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12/05/2010
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Last edited
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20/09/2011
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Date ISRCTN assigned
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12/05/2010
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