Does surface neuromuscular stimulation (NMES) to the upper limb following stroke improve outcome?

ISRCTN ISRCTN47757485
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

North Tyneside General Hospital
Rake Lane
North Shields, Tyne + Wear
NE29 8NH
United Kingdom

Phone +44 (0)191 259 6660
Email helen.rodgers@ncl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesUpper 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) studiedCardiovascular: Stroke
InterventionRandomised controlled trial to evaluate NMES. Patients hospitalised due to acute stroke randomised within 10 days to receive NMES or placebo for 4 weeks.
Intervention typeOther
Primary outcome measureOutcomes 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 measuresUpper limb pain, disability and health status.
Overall study start date01/11/2001
Completion date01/01/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants176
Key inclusion criteriaBetween 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 criteriaNot provided at time of registration
Date of first enrolment01/11/2001
Date of final enrolment01/01/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

North Tyneside General Hospital
North Shields, Tyne + Wear
NE29 8NH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Northumbria Healthcare NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Thesis results thesis 31/03/2006 No No
Results article Results 01/12/2006 Yes No