Extrait

Background and study aims Stroke is a major cause of death and one of the leading causes of severe disability in many countries. It can cause severe motor impairment which can restrict everyday activities and often independence. Many physical therapies have been explored in the last two decades to improve stroke survivors' motor ability. However, we still do not know how much therapy is needed to maximise motor-recovery after stroke. An appropriate amount of training may be a key requirement to enhance recovery after stroke. Research suggest that more therapy is better than less but findings are so far inconclusive. Current national guidelines in the UK recommend a minimum of 45 minutes of daily therapy for people after stroke, a duration not often achieved in UK therapy services and also not supported by research evidence. It is recognised that this target is based on expert opinion rather than scientific evidence. With this study we would like to fill in the gap of knowledge on the correct amount of therapy after stroke. Who can participate? Potential participants for this study will be recruited from the local community through stroke survivors' support groups. They will be adults who have moderate difficulty with their arms after stroke. What does the study involve? A group of three participants will enter the study and exercise at the same training dose. At the end of the two weeks, if the dose has been found possible and not harmful, another group of three participants will enter the study with an increased training dose. This procedure will continue until the ideal treatment dose is reached. Participants will exercise five days a week for two weeks at the assigned training dose. For this study the training dose is composed by the number of daily repetition tasks and the task intensity. For the upper limb (arm) training task participants will exercise with a three-point frame equipped by a rubber band. They should insert their fingers and thumb into the three point frame and then open the hand to take off the rubber band and then, place it on a second identical frame. Each removal and placing of a band counts as one repetition. Participants should move the band from one three-point frame to the other and back again for the number of repetitions assigned. What are the possible benefits and risks of participating? Participants will undertake a training programme when their usual care is stopped. The social nature of this study may positively impact on participants' quality of life. The risk of harm for any participants in this study is low. However, this training can result in the onset or worsening of hand/arm pain or tiredness. We will closely monitor this risk and promptly advice participants. A small risk associated with transcranical magnetic stimulation (TMS) measures concerns the exposure to electromagnet fields and may cause mild discomfort. We will avoid such risks by careful screening of participants. Where is the study run from? Movement Laboratory at the University of East Anglia, UK. When is the study starting and how long is it expected to run for? Recruitment started in March 2014. The study is planned to start at the end of May 2014 and end at the end of November 2014. Who is funding the study? The University of East Anglia, UK. Who is the main contact? Elisabetta Colucci [email protected]

Critère d'inclusion

• Stroke

Liens

• isrctn
• ictrp