Contact information
Type
Scientific
Primary contact
Dr Helen Rodgers
ORCID ID
Contact details
North Tyneside General Hospital
Rake Lane
North Shields
Tyne + Wear
NE29 8NH
United Kingdom
+44 (0)191 259 6660
helen.rodgers@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0504108438
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/11/2001
Overall trial end date
01/01/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
176
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2001
Recruitment end date
01/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Tyneside General Hospital
North Shields, Tyne + Wear
NE29 8NH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Northumbria Healthcare NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. Conference presentations:
Church C, Curless R, Huntley S, Price C, Pandyan AD, Rodgers H. Does Surface Neuromuscular Electrical Stimulation (sNMES) to the Upper Limb following Acute Stroke Improve Outcome? British Geriatrics Society Spring Meeting, March 2005
Church C, Curless R, Huntley S, Price C, Pandyan AD, Rodgers H. Does Surface Neuromuscular Electrical Stimulation (sNMES) to the Upper Limb following Acute Stroke Improve Outcome? International Stroke Conference, New Orleans, February 2005.
Church C, Curless R, Huntley S, Price C, Pandyan AD, Rodgers H. Does Surface Neuromuscular Electrical Stimulation (sNMES) to the Upper Limb Following Acute Stroke Improve Outcome? [poster] British Geriatric Society Aberdeen, April, 2003.
Church C, Curless R, Huntley S, Price C, Pandyan AD, Rodgers H. Does Surface Neuromuscular Electrical Stimulation (sNMES) to the Upper Limb Following Acute Stroke Improve Outcome? [poster] European Stroke Conference, Valencia 21st-24th May, 2003.
2. 2006 Results in http://www.ncbi.nlm.nih.gov/pubmed/17053181
Publication citations
-
Results
Church C, Price C, Pandyan AD, Huntley S, Curless R, Rodgers H, Randomized controlled trial to evaluate the effect of surface neuromuscular electrical stimulation to the shoulder after acute stroke., Stroke, 2006, 37, 12, 2995-3001, doi: 10.1161/01.STR.0000248969.78880.82.