Extract

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 supplying the brain (ischaemic stroke) or a bleed in the brain (haemorrhagic stroke). A large proportion of 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 paralysis (hemiplegia) or weakness (hemiparesis) on one side of the body, particularly the legs. Early after having a stroke, patients are keen to start rehabilitation, such as walking training to strengthen their legs and regain their mobility. However, patients are often unable to take part in such activities as they may be too weak to undertake the repetitive movements required and need a lot of help from therapy staff. Some studies have shown that repetitive motions such as pedalling exercises can help to restore movement patterns helpful to walking recovery. The aim of this study to see whether pedalling exercises on an exercise bike can help patients with severe leg weakness who are unable to take part in active therapy. Who can participate? Adults who have had a stroke with severe one-sided leg weakness making them unable to walk or in need of support from two people to do so. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group receive only conventional physical therapy (CPT). Those in the second group are given access to an adjustable exercise bike. In the first session with the bike, participants are asked to pedal for up to 30 minutes. They are then encouraged to use for up to ten minutes at a time for up to ten days before completing another 30 minute session at the end of the study. At the start of the study and then after the therapy is finished, all participants are examined and complete a number of movement tests in order to find out if there is has been any change to their muscle strength and function. What are the possible benefits and risks of participating? Participants benefit from a thorough assessment of their abilities and movement after their stroke. Participants who take part in the pedalling exercise may experience improved abilities, however this is not certain. There is a small risk that participant may experience some pain or discomfort in the legs while pedalling, however this will be closely monitored and the pace of pedalling will be adapted to each person's abilities. Where is the study run from? Norfolk and Norwich University Hospital (UK) When is the study starting and how long is it expected to run for? November 2009 to March 2011 Who is funding the study? University of East Anglia (UK) Who is the main contact? Professor Valerie Pomeroy [email protected]

Inclusion criteria

• Stroke with substantial paresis of the lower limb

Links

• ictrp
• isrctn