Re-education of arm and hand function following stroke

ISRCTN	ISRCTN12548377
DOI	https://doi.org/10.1186/ISRCTN12548377
Secondary identifying numbers	TSA 2008/2

Submission date: 14/04/2009
Registration date: 05/05/2009
Last edited: 13/04/2017

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Taylor
Scientific

The National Clinical FES Centre
Salisbury District Hospital
Salisbury
SP2 8BJ
United Kingdom

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

Study information

Study design	Interventional randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Can be found at http://www.salisburyfes.com/pdfs/pat%20info%20SA%20ReACH%20salisbury%20v1.pdf
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
Study acronym	REAcH
Study objectives	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(s)	Wiltshire Research Ethics Committee, 16/03/2009, ref: 09/H0104/9
Health condition(s) or problem(s) studied	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
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 study start date	01/04/2009
Completion date	31/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	60
Key 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
Key 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
Date of first enrolment	01/04/2009
Date of final enrolment	31/03/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The National Clinical FES Centre

Salisbury
SP2 8BJ
United Kingdom

Sponsor information

Salisbury NHS Foundation Trust (UK)
Hospital/treatment centre

Salisbury District Hospital
Odstock Road
Salisbury
SP2 8BJ
England
United Kingdom

Phone	+44 (0)1722 336262
Email	Stef.Scott@salisbury.nhs.uk
Website	http://www.salisbury.nhs.uk/
"ROR"	https://ror.org/00ja2ye75

Funders

Funder type

Research organisation

The Stroke Association (UK) (ref: TSA 2008/2)

No information available

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

Editorial Notes

13/04/2017: No publications found in PubMed, verifying study status with principal investigator