A clinical investigation of a novel functional electrical stimulation system

Mise à jour : Il y a 4 ans
Référence : ISRCTN59243785

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Extrait

Background and study aims A stroke is a serious condition where the blood supply to a part of the brain is cut off, usually by a blood clot blocking an artery (ischaemic stroke) or a bleed (haemorrhagic stroke). Around 150,000 experience a stroke each year in the UK, leaving large numbers of people living with the consequences of a stroke. Many stroke victims suffer from long-term complications depending on the area of the brain that is affected, which can affect their ability to move, speak or even their cognitive function (memory loss, difficulty reasoning and confusion). One of the most common complications of a stroke is weakness or paralysis on one side of the body. At least half of the people who survive a stroke experience reduced function in one of their arms. A number of studies show that repeating arm exercises can help to restore function, however this not much time is spent on this in current therapy on offer. Functional electrical stimulation is a treatment that uses small electrical pulses to cause muscle contractions, sequenced in such a way as to assist with the performance of functional tasks. This technology offers the potential to deliver high doses of therapy, but without needing a therapist to be continuously present. A number of studies have shown that its use may help to improve arm function following a stroke. However, there are limitations with current FES devices. For instance, many of the devices are difficult to use effectively with people who have weakness in multiple joints, while others are inflexible in the way in which they are controlled. To address this, a new FES system (FES-UPP system) has been designed to support people with arm problems following a stroke to practice functional tasks. The system has sufficient channels of stimulation to generate muscle contractions around all arm joints, and it uses information from movement sensors to decide which muscles to stimulate and when, offering flexibility in control. The aim of this study is to explore whether this FES system is able to support people with stroke to perform arm exercises they would otherwise be unable to perform unaided and how usable therapists find the system. Who can participate? Practicing therapists working with stroke patients and adults who have had a stroke and are experiencing arm weakness. What does the study involve? People with stroke take part in up to six sessions using the FES-UPP system. During one of the sessions (whichever is most convenient for the participant) participants are asked how they are finding the system and are assessed to find out how well they can perform arm exercises both when using the system and when not using the system, to see whether the system is effective in supporting people to practice these activities. Information on how much practice can be delivered using the system and any practical issues, such as how long it takes to set up the system, are also recorded. Therapists are training to use the FES-UPP system. At the end of the training, they are invited to complete two questionnaires, one on the training process and one on the system itself. They are then invited to use the FES-UPP system as required with up to 10 stroke patients. At the end of the study, they are invited to attend an interview addressing their perceptions of the system and the study design, as well as complete another questionnaire on the system design. What are the possible benefits and risks of participating? There are no notable benefits or risks involved with participating. Where is the study run from? 1. Salford Royal Hospital (UK) 2. Bury Community Stroke Team (UK) 3. Salisbury District Hospital (UK) When is the study starting and how long is it expected to run for? June 2013 to September 2017 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Ms Helen Luckie [email protected]


Critère d'inclusion

  • Specialty: Stroke, Primary sub-specialty: Rehabilitation; UKCRC code/ Disease: Stroke/ Cerebrovascular diseases

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