Extrait

Background and study aims Loss of the ability to use an arm affects up to 85% of people who have recently had a stroke. People report that losing the use of their arm is one of the most distressing long term symptoms of stroke. Some people feel that rehabilitation does not focus enough on arm recovery. At the moment it is unclear how to best provide therapy to improve arm recovery. Recent research has suggested that recovery may be improved by practising activities a lot of times, especially if the activity is for a specific functional purpose. An example of an activity for a functional purpose is ‘use your affected hand to touch your cheek with a flannel'. This type of therapy is called ‘Repetitive Functional Task Practice’ (RFTP). Previous research about RFTP therapy has not allowed us to say for sure that this treatment will improve recovery of arm function. In order to test whether RFTP therapy will improve arm recovery, we need to conduct a large research study. However, before we do a large clinical trial it’s important to do a small version of the trial (a pilot trial) to check that the design and logistics of the trial are acceptable. This study is a small pilot trial which will enable us to design the large clinical trial to determine if RFTP therapy will improve arm recovery after stroke. Who can participate? We are inviting people to take part who have recently had a stroke which has caused problems with how they can use their arm. What does the study involve? In this pilot trial, people are randomly allocated to one of the two groups, one group the new treatment (called the ‘intervention group’) and the other group ‘standard’ treatment (called the ‘control group’). Results and feedback from both groups are examined. In this pilot trial, the new treatment is a RFTP therapy programme and ‘standard’ treatment is usual rehabilitation. Everybody who agrees to take part in the study will be asked to undertake three research assessments. Assessment 1 will take place after they agree to take part in the study, assessment 2 one month after they enter the study and assessment 3 three months after they enter the study. At each assessment a member of the research team will ask participants some questions about how their stroke is affecting their everyday life and ask them to perform some movements with their arms. People who are placed into the group which receive the RFTP therapy programme will be asked to follow the RFTP programme. This will include practising activities independently, twice each day for four weeks. In addition, people who receive the RFTP programme will be seen by a therapist twice per week for four weeks. The therapist will review progress, adjust activities if needed and ask for comments on how they are finding the programme. The programme is in addition to the usual rehabilitation they normally receive. People who are placed into the group which receive usual rehabilitation will continue with the usual post stroke rehabilitation. What are the possible benefits and risks of participating? All participants taking part in this research study will be provided with advice and information about stroke, rehabilitation and positioning of the arm and hand after stroke which we hope they will find interesting and useful. Participants provided with the RFTP programme will receive arm therapy (RFTP programme) which is extra to the therapy they are receiving. Research has suggested that arm recovery may be faster when extra treatment is given early after stroke. This could possibly speed up how quickly they can use their arm again. Having this programme to practise at this early time after stroke will hopefully make the most of the time where potential recovery of the arm is greatest. Research has also suggested (but not proven) that people who have had a stroke are helped most by practising everyday activities. These are the types of activities we are using in the RFTP programme. All participants in this research project will be asked to take part in research assessments which examine how their stroke has affected their arm and the effects their stroke is having on their everyday life. Some participants may find this tiring or upsetting. Participants who receive the RFTP programme may notice some discomfort in their arm when practising the programme but this should be no greater than the discomfort they may feel during usual rehabilitation therapy. It is very common for people to feel tired after a stroke. Participants who receive the RFTP programme will be practising the programme in addition to their usual rehabilitation which could make them feel more tired. Where is the study run from? The study coordinating Centre is Newcastle University. We have three study sites who are recruiting participants for our study; North Tees and Hartlepool NHS Foundation Trust, Gateshead Health NHS Foundation trust and South Tees Hospitals NHS Foundation Trust, all based in the UK. When is the study starting and how long is it expected to run for? November 2012 to August 2014 Who is funding the study? The Stroke Association (UK) Who is the main contact? Lianne Brkic [email protected]

Critère d'inclusion

• Topic: Stroke Research Network; Subtopic: Stroke / Rehabilitation

Liens

• ictrp
• isrctn