Strength training with Electrical Stimulation - is this a viable method of facilitating independent mobility and improving quality of life after a moderate to severe stroke?

ISRCTN ISRCTN99172250
DOI https://doi.org/10.1186/ISRCTN99172250
Secondary identifying numbers AP1131
Submission date
21/09/2009
Registration date
28/09/2009
Last edited
22/11/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Anand Pandyan
Scientific

School of Health and Rehabilitation
Keele University
Staffordshire
ST5 5GB
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Scientific titleStrength 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
Study objectivesTo develop a therapy protocol to prevent deterioration of muscle performance after a moderate to severe stroke.
Ethics approval(s)South Manchester (Northwest 6- GM South) Research Ethics Committee approved on the 4th August 2008 (ref: 08/H1003/44)
Health condition(s) or problem(s) studiedStroke
InterventionTreatment:
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 typeOther
Primary outcome measureMuscle strength, measured at 0, 3 and 6 weeks
Secondary outcome measuresMeasured 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 study start date01/03/2009
Completion date20/08/2009

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants10 acute stroke patients: 5 treatment, 5 control
Key inclusion criteria1. 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
Key exclusion criteriaContraindication to electrical stimulation (i.e., orthopaedic implants at stimulation site, active cardiac implants, and skin reactions to electrodes)
Date of first enrolment01/03/2009
Date of final enrolment20/08/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Keele University
School of Health and Rehabilitation
Newcastle
ST5 5GB
United Kingdom

Sponsor information

Keele University (UK)
University/education

School of Health and Rehabilitation
Staffordshire
ST5 5GB
England
United Kingdom

Website http://www.keele.ac.uk/
ROR logo "ROR" https://ror.org/00340yn33

Funders

Funder type

Charity

Action Medical Research (UK) (ref: AP1131)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
actionmedres, action medical research for children, AMR
Location
United Kingdom

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

Editorial Notes

22/11/2019: No publications found, verifying study status with principal investigator.
01/02/2016 No publications found, verifying study status with principal investigator.