Plain English Summary
Background and study aims
A stroke is a serious condition where the blood supply to a part of the brain is cut off, usually by a blood clot blocking an artery supplying the brain (ischaemic stroke) or a bleed in the brain (haemorrhagic stroke). A large proportion of stroke victims suffer from long-term complications depending on the area of the brain that is affected, which can affect their ability to move, speak or even their cognitive function (memory loss, difficulty reasoning and confusion). One of the most common complications of a stroke is paralysis (hemiplegia) or weakness (hemiparesis) on one side of the body, particularly in the legs. It is important to start rehabilitation therapy as soon as possible after stroke as it gives patients the best chance of regaining their range of movement. Studies have shown however that even in patients who take part in active rehabilitation, the movement capabilities may never be restored. This can lead to patients not moving around as much and weakening of the muscles. Electrical stimulation is a technique in which the muscles and nerves are stimulated by pulses of electricity. This activation of muscles could help to prevent them from wasting away and even restore movement. The aim of this study is to find out whether electrical stimulation treatment can help to improve muscle strength and restore movement in stroke patients.
Who can participate?
Stroke patients under 80 years old who are unable to mobilise independently.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in six weeks of standard NHS therapy treatment combined with electrical stimulation treatment. This involves three sessions a week in which the muscles of the calf (gastrocnemius) and the front of the thigh (quadriceps) have a small electrical current applied to them. Those in the second group receive standard NHS therapy treatment only and are then monitored for six weeks. At the start of the study, and then again after 3 and 6 weeks, participants in both groups have their muscle strength and range of movement measured.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Keele University (UK)
When is the study starting and how long is it expected to run for?
March 2009 to August 2009
Who is funding the study?
Action Medical Research (UK)
Who is the main contact?
Dr Anand Pandyan
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AP1131
Study information
Scientific title
Strength training with Electrical Stimulation: a randomised controlled trial of a viable method of facilitating independent mobility and improving quality of life after a moderate to severe stroke
Acronym
Study hypothesis
To develop a therapy protocol to prevent deterioration of muscle performance after a moderate to severe stroke.
Ethics approval
South Manchester (Northwest 6- GM South) Research Ethics Committee approved on the 4th August 2008 (ref: 08/H1003/44)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Stroke
Intervention
Treatment:
Six weeks treatment, three times per week with electrical stimulation on quadriceps, and gastrocnemius, combined with standard NHS therapy treatment.
Control:
Six weeks of monitoring progress after standard NHS therapy treatment.
There will be a measurement at the end of treatment but no further follow-up.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Muscle strength, measured at 0, 3 and 6 weeks
Secondary outcome measures
Measured at 0, 3 and 6 weeks:
1. Electromyography
2. Range of movement
3. Magnetic Resonance Imaging (MRI) of muscle volume
4. Ultrasound imaging for muscle architecture
5. Barthel Index
6. Nottingham Extended Activities of Daily Living (NEADL)
7. Visual analogue scale
8. Fatigue severity scale
9. Timed up and go
10. 10-metre walk
Overall trial start date
01/03/2009
Overall trial end date
20/08/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Below age of 80 years, either sex
2. Medically stable
3. Capable of providing informed consent
4. Patients who can sit and transfer independently, however who are unable to mobilise
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
10 acute stroke patients: 5 treatment, 5 control
Participant exclusion criteria
Contraindication to electrical stimulation (i.e., orthopaedic implants at stimulation site, active cardiac implants, and skin reactions to electrodes)
Recruitment start date
01/03/2009
Recruitment end date
20/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Keele University
School of Health and Rehabilitation
Newcastle
ST5 5GB
United Kingdom
Sponsor information
Organisation
Keele University (UK)
Sponsor details
School of Health and Rehabilitation
Staffordshire
ST5 5GB
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Action Medical Research (UK) (ref: AP1131)
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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