Pilot study to investigate the effectiveness of combining physiotherapy and electrical stimulation to improve mobility in recently discharged stroke patients

ISRCTN	ISRCTN91639560
DOI	https://doi.org/10.1186/ISRCTN91639560
Secondary identifying numbers	Version 1

Submission date: 09/03/2007
Registration date: 16/07/2007
Last edited: 18/04/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Taylor
Scientific

The National Clinical Functional Electrical Stimulation Systems Centre
Salisbury NHS Foundation Trust
Salisbury District Hospital
Salisbury
SP2 8BJ
United Kingdom

Phone	+44 (0)1722 429119
Email	p.taylor@salisburyfes.com

Study information

Study design	Randomised controlled pilot study.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Patient information can be found at: http://www.salisburyfes.com/index2.htmReferral criteria and treatment protocol on: http://www.salisburyfes.com/pdfs/referral.PDF
Scientific title	Pilot study to investigate the effectiveness of combining physiotherapy and electrical stimulation to improve mobility in recently discharged stroke patients
Study acronym	EPIC - Electrical stimulation as Part of Integrated Physiotherapy
Study objectives	Electrical stimulation improves mobility, when delivered as an integrated part of outpatient physiotherapy for people less than 6 months post stroke. This pilot study will investigate the use of electrical stimulation integrated into physiotherapy to improve gait in early stroke rehabilitation. The study will take place in a realistic clinical setting using techniques appropriate to a typical outpatient physiotherapy department. Stimulation will be applied to improve gait directly during walking. By using electrical stimulation in gait it is hoped to facilitate a more normal muscle activation pattern. It will also be used on various lower limb muscle groups as exercise to promote muscle strength, reduce antagonist spasticity and improve range of movement. During exercise and walking multiple muscle groups could be stimulated guided by the patient's particular problems.
Ethics approval(s)	Approved by Wiltshire Ethics Committee (ref: 07/Q2004/19)
Health condition(s) or problem(s) studied	Cerebral vascular accident/stroke
Intervention	A randomised controlled pilot study model will be used. 30 people who have had a stroke less than 6 months previously with a Rivermead Mobility Index score between 6 and 10 will be randomly assigned to a treatment or control group. The control group will receive physiotherapy appropriate to their needs while the treatment group will receive physiotherapy with the addition of electrical stimulation. All subjects will receive 2 physiotherapy sessions of duration 1 hour a week for 6 weeks. Subjects will be instructed in exercises to perform at home, which will include electrical stimulation in the treatment group.
Intervention type	Other
Primary outcome measure	Walking speed over 10 m assessed at Week 1, Week 8 and Week 20. This has been shown to correlate well with more sophisticated measures of gait and is used routinely in the Salisbury Functional Electrical Stimulation Systems (FES) Clinic for comparison and audit purposes.
Secondary outcome measures	The following will be assessed at Week 1, Week 8 and Week 20: Walking: 1. Effort as measured by Physiological Cost Index over 10 m. Polar heart rate monitor is used for non-invasive estimation of effort during the walking tests. 2. Visual gait analysis from video by blinded assessor using Rivermead Visual Gait Assessment from video when participants are able to walk sufficient distances. This measure should reflect changes in gait quality. Function: 3. Six-minute walk. This simple test is suggested as way of quantifying change in walking ability with less floor or ceiling effects than walking tests over shorter distances. Six and 12 minute walks have been shown to be responsive to change and useful in documenting gait outcome over an inpatient stay. Participation: 4. Canadian Occupational Performance Measure. This measures change in activities of daily living and assesses self-perceived satisfaction and performance. This outcome measure allows trial participants to focus on relevant personal problems and concerns. 5. Hospital Anxiety and Depression Scale, a widely used indicator of mood. 6. Rivermead Mobility Index to measure changes in mobility and to inform one of the selection criteria.
Overall study start date	15/04/2007
Completion date	15/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	30
Key inclusion criteria	1. Participants will be over 18 years 2. Participants will be medically fit enough to undertake physiotherapy (consultant and GP approval will be sought prior to starting the trial) 3. Current inpatient stay will be for rehabilitation following first stroke 4. During the inpatient period participants will have demonstrated they have sufficient motivation, memory and cognitive ability to participate in treatment within physiotherapy and practice outside of treatment sessions 5. Patients will be able to understand spoken instructions 6. Participants' goals must include improving gait 7. Suitable patients will be returning home after hospital discharge with a Rivermead Mobility Index of between 6 and 10 8. Participants will be able to attend the hospital for twice weekly physiotherapy i.e. will have suitable transport and live within 25 miles of the hospital
Key exclusion criteria	1. Unable to tolerate sensation of stimulation (assessed prior to acceptance onto the trial) 2. Poor skin condition making stimulation unsuitable 3. Previous neurological conditions likely to influence response to treatment 4. Orthopaedic/other health problems limiting ability to participate or use stimulation/physiotherapy 5. Score of 25 or under on Mini Mental Test 6. Pacemaker and other active implant users 7. Poorly controlled epileptics 8. Pregnancy
Date of first enrolment	15/04/2007
Date of final enrolment	15/04/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The National Clinical Functional Electrical Stimulation Systems Centre

Salisbury
SP2 8BJ
United Kingdom

Sponsor information

Salisbury NHS Foundation Trust (UK)
Hospital/treatment centre

Salisbury NHS Foundation Trust
Salisbury District Hospital
Wiltshire
Salisbury
SP2 8BJ
England
United Kingdom

Phone	+ 44 (0)1722 425027
Email	Stef.Scott@salisbury.nhs.uk
"ROR"	https://ror.org/00ja2ye75

Funders

Funder type

Charity

Stroke Association (ref: TSA 2006/2007) (UK)
Private sector organisation / Associations and societies (private and public)

Location: United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2015		Yes	No

Editorial Notes

18/04/2016: Publication reference added