Contact information
Type
Scientific
Primary contact
Dr Paul Taylor
ORCID ID
Contact details
The National Clinical Functional Electrical Stimulation Systems Centre
Salisbury NHS Foundation Trust
Salisbury District Hospital
Salisbury
SP2 8BJ
United Kingdom
+44 (0)1722 429119
p.taylor@salisburyfes.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1
Study information
Scientific title
Pilot study to investigate the effectiveness of combining physiotherapy and electrical stimulation to improve mobility in recently discharged stroke patients
Acronym
EPIC - Electrical stimulation as Part of Integrated Physiotherapy
Study hypothesis
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
Approved by Wiltshire Ethics Committee (ref: 07/Q2004/19)
Study design
Randomised controlled pilot study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient 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
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
15/04/2007
Overall trial end date
15/04/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
15/04/2007
Recruitment end date
15/04/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The National Clinical Functional Electrical Stimulation Systems Centre
Salisbury
SP2 8BJ
United Kingdom
Sponsor information
Organisation
Salisbury NHS Foundation Trust (UK)
Sponsor details
Salisbury NHS Foundation Trust
Salisbury District Hospital
Wiltshire
Salisbury
SP2 8BJ
United Kingdom
+ 44 (0)1722 425027
Stef.Scott@salisbury.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Stroke Association (ref: TSA 2006/2007) (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24827386