Contact information
Type
Scientific
Primary contact
Dr Paul Taylor
ORCID ID
Contact details
The National Clinical FES Centre
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
TSA 2008/2
Study information
Scientific title
A randomised controlled trial of an accelerometer-triggered functional electrical stimulation (FES) device for recovery of upper limb function in chronic stroke patients
Acronym
REAcH
Study hypothesis
That accelerometer-triggered functional electrical stimulation (FES) to the finger, thumb, wrist and elbow extensors may be a useful treatment to assist upper limb recovery of function following stroke and is more effective than conventional physiotherapy methods.
Ethics approval
Wiltshire Research Ethics Committee, 16/03/2009, ref: 09/H0104/9
Study design
Interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Can be found at http://www.salisburyfes.com/pdfs/pat%20info%20SA%20ReACH%20salisbury%20v1.pdf
Condition
Stroke more than 6 months post-cerebrovascular accident (CVA)
Intervention
Intervention group:
Functional electrical stimulation of the wrist, finger, thumb and elbow extensors, triggered using a movement sensor (an accelerometer) detecting an attempt to reach forward to grasp an object. Stimulation is delivered through self-adhesive skin electrodes placed over the extensor muscles. A stimulator/controller is carried on the arm. The stimulation helps complete the reaching function by extending the elbow and wrist and opening the hand.
Comparator group:
Conventional physiotherapy exercises mimicking the action of the device but without the assistance of FES.
Both groups use the treatment for 12 weeks. Outcomes are assessed then and 12 weeks later.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Action Research Arm Test (ARAT). The ARAT was chosen as it includes elements of both shoulder, arm and hand function.
Assessments are made at the beginning of the baseline period (-6 weeks) at the end of the baseline (week 0), at the end of the treatment period (week 12) and 12 weeks after the intervention is removed (week 24).
Secondary outcome measures
Impairment:
1. Fugl-Meyer Test (FM): a measure of impairment commonly reported in similar studies in the literature, so enabling comparison with other trials
2. Modified Ashworth Scale (MAS): to measure elbow, wrist and finger spasticity. Spasticity is a major inhibition to the use of the hand and high tone levels can be distressing. Increased tone would be an indication of an adverse response to treatment.
Function:
3. Box and Block Test (B&B): a measure of dexterity. This functional test has been added as it has fewer elements of subjectivity than the ARAT.
Activities of daily living:
4. Canadian Occupational Performance Measure (COPM): to assess patient perception of their performance and their satisfaction with activities of daily living
Quality of life:
5. Stroke Impact Scale (SIS): a measure of the impact of stroke on quality of life
Cost analysis:
6. Cost effectiveness and cost utility: for the cost-effectiveness analyses an appropriate clinical measure will be chosen from the above outcome measures. For the cost-utility study health outcomes will be measured by the health states reported by patients using the EQ-5D questionnaire. These health profiles will be converted to utility values using the published population utility tariffs for the EQ-5D. Costs related to service use incurred by the research volunteers will be recorded using a purpose designed Client Service Receipt Inventory (CSRI) form. Treatment cost will be recorded using case report forms (TCRF) to be completed by the clinical staff throughout the project.
Research Volunteer perspective of treatment:
7. Use of Device Questionnaire (UDQ): this custom questionnaire will be used to systematically record the research volunteers' experiences and opinions about their treatment
Compliance:
8. Each subject will be asked to complete a compliance diary
Safety:
9. Safety will be assessed by recording adverse incidents
Assessments are made at the beginning of the baseline period (-6 weeks), at the end of the baseline (week 0), at the end of the treatment period (week 12) and 12 weeks after the intervention is removed (week 24).
Overall trial start date
01/04/2009
Overall trial end date
31/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. First stroke leading to hemiplegia
2. Aged 18 years and above (no upper age limit), either sex
3. Reduced hand and arm function, limiting voluntary elbow extension and hand opening
4. Medically stable
5. Able to understand and comply with assessment procedures
6. Able to give informed consent
7. Minimum 45 degrees active shoulder flexion
8. Able to initiate elbow extension
9. Enough active wrist and finger extension to pick up and release a 2.5 cm cube (easiest task in grasp section of Action Research Arm Test [ARAT])
10. Responds to stimulation to open the hand
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. An ARAT score of greater than 40 (out of 57) at initial assessment
2. Any existing orthopaedic condition affecting the upper limb
3. Cardiac pacemaker
4. Painful shoulder
5. Fixed contractures at elbow, wrist or fingers
6. Pregnancy
7. Malignancy in the area of the electrodes
8. A history of poorly controlled epilepsy
Recruitment start date
01/04/2009
Recruitment end date
31/03/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The National Clinical FES Centre
Salisbury
SP2 8BJ
United Kingdom
Sponsor information
Organisation
Salisbury NHS Foundation Trust (UK)
Sponsor details
Salisbury District Hospital
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
+44 (0)1722 336262
Stef.Scott@salisbury.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
The Stroke Association (UK) (ref: TSA 2008/2)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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