None listed
Conditions
Brief summary
For the 15 million new people each year globally suffering stroke, 85% have difficulty moving their arm and hand, and 60% still have non-functional arms 6 months after stroke. Evidence for more effective treatments is needed. This project is a multicentre randomised controlled study, with 300 participants, to test the hypothesis that task-specific training is more effective in improving upper limb function compared to usual care. Participants will be recruited from the community, at 3 months after stroke. They will receive 6 weeks treatment, at home, of either task-specific training or usual care. Task-specific training will be delivered according to a detailed exercise manual. Participants receive 14 x 1 hour visits from a therapist and will perform in addition 1 hour/day of self-practice. The primary outcome measure is the Action Research Arm Test performed immediately after the 6 weeks of treatment, and repeated at 6 months.
Interventions
Task-specific intervention: The intervention will be guided by a detailed protocol. The intervention will occur in the participant's home. In brief, the intervention therapist analyses the whole of the task which is to be trained, e.g. reach-to-grasp, to identify movement parts to be prioritised for training and individual movement performance targets to be reached. This will be necessarily different for each participant, The person's visual attention is directed to regulatory cues in the environment, which is organised to be functionally relevant, individualised and varied, by providing meaningful everyday objects of different sizes, weight and shape, in different positions. The therapist’s role is like a sports coach. He/she uses knowledge of critical biomechanical characteristics of the task to give instructions (by demonstration or verbally) which are concrete and task oriented. Repetitive practice and motor learning principles are used to empower the participant to practice on their own. Training will be delivered according to an exercise manual containing 144 exercises words and photographs including variations of the exercises to allow for different levels of difficulty and complexity. Participants receive 14 x 1 hour visits from a therapist over the 6 weeks (3 visits week 1-3, 2 visits week 4-5, 1 visit week 6). This will replace any usual care training for the upper limb. The intensity of practice within each 1-hour session will be dependent on individual participant’s capabilities, but high numbers of repetitions will be encouraged, with the aim of delivering between 100 and 300 repetitions within each 1-hour session. Beyond the target of 100-300 reps, participants will do as many as they can accomplish in 1 hour, within limits of fatigue. Task-specific training will be delivered by therapists appointed from the study budget. There will be a minimum of 4 therapists delivering treatment in each arm of the trial. Self practice: Participants will be asked to perform in addition 1 hour/day of self-practice. Compliance is encouraged by joint goal-setting, providing a booklet about recovery from stroke emphasising potential for ‘rewiring’ the brain through practice (Smith, Forster et al. 2008), and using digital counters to record . The role of the carer will be to encourage the participant to practice and assist with equipment to enable practice and with recording practice.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Diagnosis of primary or recurrent stroke , including stroke caused by focal cerebral infarction (ischemic stroke), intracerebral haemorrhage, subarachnoid haemorrhage and cerebral venous thrombosis (Sacco, Kasner et al. 2013) 2. Participant discharged home (i.e. permanent address, may include care home/sheltered accommodation) 3. Participant at approximately 3 months post stroke (between 2.5 and 3.5 months post stroke) 4. Has remaining upper limb movement deficit defined as being unable to pick up a 6mm ball bearing from the table top, between index finger and thumb, and place it on a shelf 37 cm above table (item from Action Research Arm Test) 5. Informed written consent
Exclusion criteria
1. Upper limb movement deficits attributable to non-stroke pathology 2. Unable to lift hand off lap when asked to place hand behind head 3. Severe fixed contractures of elbow or wrist (i.e. grade 4 on the modified Ashworth scale)