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 designInterventional randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Can be found at http://www.salisburyfes.com/pdfs/pat%20info%20SA%20ReACH%20salisbury%20v1.pdf
Scientific titleA randomised controlled trial of an accelerometer-triggered functional electrical stimulation (FES) device for recovery of upper limb function in chronic stroke patients
Study acronymREAcH
Study objectivesThat 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) studiedStroke more than 6 months post-cerebrovascular accident (CVA)
InterventionIntervention 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 typeOther
Primary outcome measureAction 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 measuresImpairment:
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 date01/04/2009
Completion date31/03/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2009
Date of final enrolment31/03/2012

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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