Does surface neuromuscular stimulation (NMES) to the upper limb following stroke improve outcome?
ISRCTN | ISRCTN47757485 |
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DOI | https://doi.org/10.1186/ISRCTN47757485 |
Secondary identifying numbers | N0504108438 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 28/10/2010
- 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 of protocol
Not provided at time of registration
Contact information
Dr Helen Rodgers
Scientific
Scientific
North Tyneside General Hospital
Rake Lane
North Shields, Tyne + Wear
NE29 8NH
United Kingdom
Phone | +44 (0)191 259 6660 |
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helen.rodgers@ncl.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | Upper limb impairment affects 80% of stroke patients, half of whom still experience problems three months later. Surface neuromuscular electrical stimulation (sNMES) after stroke may improve upper limb function but current evidence is inconclusive. We have undertaken a randomised controlled trial (RCT) to evaluate a programme of upper limb sNMES following acute stroke. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Cardiovascular: Stroke |
Intervention | Randomised controlled trial to evaluate NMES. Patients hospitalised due to acute stroke randomised within 10 days to receive NMES or placebo for 4 weeks. |
Intervention type | Other |
Primary outcome measure | Outcomes compared at end of treatment period and at 3 months. The primary outcome measure was the Action Research Arm Test (ARAT) 3 months after stroke. |
Secondary outcome measures | Upper limb pain, disability and health status. |
Overall study start date | 01/11/2001 |
Completion date | 01/01/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 176 |
Key inclusion criteria | Between 1st January 2002 and 29th February 2004, subjects admitted with acute stroke to two stroke units were assessed against eligibility criteria: residence within 15 miles of participating hospitals; within 10 days of stroke onset; new upper limb impairment; medically stable; no cognitive/language impairments or previous upper limb problem likely to influence assessments; no other diagnosis likely to interfere with rehabilitation or significant previous co-morbidity; no contraindication to sNMES. Recruitment to begin at North Tyneside Hospital, funding applied for to extend recruitment to Wansbeck. Randomisation by a central independent telephone computerised service based at the University of Newcastle upon Tyne. |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/11/2001 |
Date of final enrolment | 01/01/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
North Tyneside General Hospital
North Shields, Tyne + Wear
NE29 8NH
United Kingdom
NE29 8NH
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Government
Northumbria Healthcare NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Thesis results | thesis | 31/03/2006 | No | No | |
Results article | Results | 01/12/2006 | Yes | No |