Condition category
Circulatory System
Date applied
21/09/2009
Date assigned
28/09/2009
Last edited
05/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Anand Pandyan

ORCID ID

Contact details

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

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

http://www.keele.ac.uk/

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

Publication citations

Additional files

Editorial Notes

01/02/2016 No publications found, verifying study status with principal investigator.