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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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 design	Randomised controlled trial
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

Participant type(s)	Patient
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

North Tyneside General Hospital

North Shields, Tyne + Wear
NE29 8NH
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Government

Northumbria Healthcare NHS Trust (UK)

No information available

Intention to publish date
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

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