http://www.isrctn.com/ISRCTN15412695?q=&filters=&sort=&offset=78&totalResults=15353&page=1&pageSize=100&searchType=basic-search
- Prospective/Retrospective
- Prospectively registered
- Overall trial status
- Ongoing
- Recruitment status
- Recruiting
Plain English Summary
Background and study aimsA 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). A large proportion of stroke victims suffer from long-term complications depending on the area of the brain that is affected, affecting their ability to speak, think and move. People with severe stroke experience significant muscle weakness which means that they spend much of their time in bed or sitting. This inactivity can cause their muscles to become even weaker and stiffer and may lead them to experience sudden drops in blood pressure when they move from lying to standing (orthostatic hypotension (OH). This further interferes with their ability to participate in intensive stroke rehabilitation, overall recovery and quality of life. Currently physiotherapy for people with severe stroke concentrates on practicing tasks such as getting in and out of bed into a chair that are important for independence and achieving safe discharge home. Standing up early after a stroke may help strengthen muscles, reduce OH and minimise or prevent muscles becoming stiff and weaker. A standing frame has the ability to assist people with severe stroke safely into a supported standing posture, however there are not given to patients when discharged and are not often used in stroke rehabilitation units. This study aims to assess whether it is possible for people with severe stroke to use a standing frame to practice functional movements such as standing and moving between sitting and standing during their hospital-based rehabilitation.
Who can participate?
Adults with severe stroke who are patients in participating Stroke Rehabilitation Units in Cornwall and Devon.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in the functional standing frame programme. This involves a maximum of 30 minutes using the standing frame plus an additional 15 minutes to provide time for usual physiotherapy where participants may practise transfers, arm activities or activities chosen by participants or guided by physiotherapists. Participants will undertake the functional standing frame programme for ideally up to five days per week for a total of three weeks. Those in the second group practice routine physiotherapy stroke rehabilitation for 45 minutes per day (or as long as a tolerated) ideally up to five days per week for three weeks. Participants in both groups complete a range of assessments and questionnaires at the start of the study and then again after three, six and twelve months to assess their function and ability to undertake activities of daily living.
What are the possible benefits and risks of participating?
Participants who use the standing frame may benefit from improvements to their symptoms and enhanced recovery. There are no notable risks involved with participating.
Where is the study run from?
1. Camborne Redruth Community Hospital (UK)
2. Bodmin Community Hospital (UK)
3. Skylark Ward, Stroke Rehabilitation Unit (UK)
4. Elizabeth Ward, Stroke Rehabilitation Unit (UK)
When is the study starting and how long is it expected to run for?
April 2016 to March 2019
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Miss Angie Logan
angie.logan@plymouth.ac.uk
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