Condition category
Circulatory System
Date applied
14/04/2009
Date assigned
05/05/2009
Last edited
29/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.salisbury.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes