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| [ ...Back to search results ] | [ Print-friendly version ] |
| Pilot study to investigate the effectiveness of combining physiotherapy and electrical stimulation to improve mobility in recently discharged stroke patients |
| ISRCTN | ISRCTN91639560 |
| ClinicalTrials.gov identifier | |
| Public title | Pilot study to investigate the effectiveness of combining physiotherapy and electrical stimulation to improve mobility in recently discharged stroke patients |
| Scientific title | |
| Acronym | EPIC - Electrical stimulation as Part of Integrated Physiotherapy |
| Serial number at source | Version 1 |
| Study hypothesis | Electrical stimulation improves mobility, when delivered as an integrated part of outpatient physiotherapy for people less than 6 months post stroke. |
| Lay summary | |
| Ethics approval |
Approved by Wiltshire Ethics Committee (ref: 07/Q2004/19)
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| Study design | Randomised controlled pilot study. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Cerebral vascular accident/stroke |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 15/04/2007 |
| Anticipated end date | 15/04/2009 |
| Status of trial | Completed |
| Patient information material | Patient information can be found at: http://www.salisburyfes.com/index2.htm Referral criteria and treatment protocol on: http://www.salisburyfes.com/pdfs/referral.PDF |
| Target number of participants | 30 |
| Interventions |
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.
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. |
| Primary outcome measure(s) | 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 measure(s) |
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. |
| Sources of funding | Stroke Association (ref: TSA 2006/2007) (UK) |
| Trial website | http://www.salisburyfes.com |
| Publications | |
| Contact name | Dr Paul Taylor |
| Address |
The National Clinical Functional Electrical Stimulation Systems Centre
Salisbury NHS Foundation Trust Salisbury District Hospital |
| City/town | Salisbury |
| Zip/Postcode | SP2 8BJ |
| Country | United Kingdom |
| Tel | +44 (0)1722 429119 |
| Fax | +44 (0)1722 425263 |
| p.taylor@salisburyfes.com | |
| Sponsor | Salisbury NHS Foundation Trust (UK) |
| Address |
Salisbury NHS Foundation Trust
Salisbury District Hospital Wiltshire |
| City/town | Salisbury |
| Zip/Postcode | SP2 8BJ |
| Country | United Kingdom |
| Tel | + 44 (0)1722 425027 |
| Stef.Scott@salisbury.nhs.uk | |
| Date applied | 09/03/2007 |
| Last edited | 07/08/2007 |
| Date ISRCTN assigned | 16/07/2007 |
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| © 2012 ISRCTN unless otherwise stated. | |
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