Upper limb retraining in stroke

NIHR

london clinical trials, clinical research london

ISRCTN96487050
Primary Trial ID Number

Research Details
Following stroke 30% patients have persistent motor deficits. There is growing evidence that augmenting exercise therapy time after stroke improves outcome. In practice, increasing therapy time demands costly increases in staffing. Robotic aids can provide high-intensity, repetitive, task-specific, interactive treatment of the impaired upper limb. Aim: To conduct a feasibility study of use of a cheap, portable, robotic aid for delivering repetitive practice of reach, supination and manipulation. Methods: Examination of 100 consecutive patients to establish the proportion of acute stroke patients could potentially benefit from rehabilitation using an aid. Study outputs: At the end of the study we will have identified the proportion of stroke patients who can use this robotic aid and the resource implications, the most responsive functional measure and the size of an appropriately powered control trial.

Study Design
Single-centre randomised interventional treatment trial

Intervention
The study is recruiting the first 100 stroke patients admitted to UCLH trusts. Subjects following consent to participate are to have baseline outcome measures taken. If participants have arm impairments these measures are retaken at 6 weeks or on discharge if earlier. Subjects with arm impairments are also assessed weekly to see if they can interface with a mock up of a robotic device. Patients will be assessed by a physiotherapist seven days after admission and weekly for the first six weeks or until they are discharged, whichever is the earlier. A final assessment will take place for all patients at six weeks

Primary Outcome Measures
Measured seven days after admission, then weekly until 6 weeks:
1. Action Research Arm Test (ARAT)
2. Disabilities of Arm, Shoulder, Hand (DASH)
3. Chedoke Arm and Hand Inventory
4. Measure of manual ability for adults with upper limb impairments (ABILHAND)
5. Stroke Rehabilitation Assessment of Movement (STREAM)
Secondary Outcome Measures
Measured seven days after admission, then weekly until 6 weeks:
1. Barthel Index
2. European Quality of Life Questionnaire (EQ-5D)
3. 36-item Short Form Health Survey (SF36)
4. National Institutes of Health Stroke Scale (NIHSS)

Gender
Both

Who Can Participate
Patient
Number of Participants
Planned sample size: 100; UK sample size: 100
Participant Inclusion Criteria
1. Confirmed stroke
2. Capable of giving informed consent
3. One hundred consecutive stroke patients (all ages, either sex)

Trial Location(s)
Receptos Study Site 967
London
WC1N 3BG
Trial Contact(s)
Primary Trial Contact
Prof Diane Playford
d.playford@ion.ucl.ac.uk

Countries Recruiting
United Kingdom

Scientific Title
A feasibility study of use of a cheap, portable, robotic aid for delivering repetitive practice of reach, supination and manipulation in acute stroke

Funder(s)
The Stroke Association (UK) (ref: TSA 2007/14)
Other Study ID Numbers
7511
Sponsor(s)
National Hospital for Neurology and Neurosurgery (UK)

To apply for this job please visit the following URL: http://www.ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialId=14750 →