Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
28/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

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

  1. 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.

Additional files

Editorial Notes