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Clinical Trial Summary

Stroke is the third most common cause of mortality and the leading cause of long term disability worldwide with over 900,000 people living in England who have had a stroke. 75% of survivors regain their ability to walk again, however it is estimated that between 55 and 75% fail to regain satisfactory use of their impaired arm. This limits the person's independence, ability to care for themselves and reduces their quality of life. Research indicates that for optimal recovery, high levels of rehabilitation are required yet current provision often fails to meet the required levels of intensity and duration of therapy.

In conjunction with stroke patients, their families and therapists, the team developed a low cost system (the virtual glove) to encourage stroke survivors to practice arm exercises at home. The system tracks infrared light emitting diodes (LEDs) positioned on the fingers turning the hand into a game controller to play games that encourage the movements of reach, grasp and release that underlie activities of daily living.

Before examining its effectiveness, the purpose of the registered study is to determine how feasible a large trial would be in terms of whether sufficient participants could be recruited, whether they would use the glove and whether outcome measures could be collected.

Patients will be recruited if they are aged 18 years or over, are recovering from a stroke, no longer receive any other intensive rehabilitation but still experiencing difficulty using their arm. After baseline measures are collected they will be randomly allocated to either the intervention group or a control group. The intervention group will have the virtual glove and games at home for a period of eight weeks and be advised to use the equipment for 20 minutes, three times a day. The control group will continue to have whatever care they are already receiving but no new interventions.

Outcome measures will be collected at baseline, four weeks and after the equipment has been removed from their home. Outcome measures will include tests of arm function as well participant reports of how often they are using their affected arm and how easy they find activities of daily living. The therapists collecting the outcome measures will not know to which group the participants have been allocated.

Once all outcome measures are collected the two groups will be compared on how much their final outcome measures differ from those collected at baseline.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02637791
Study type Interventional
Source University of Nottingham
Contact
Status Completed
Phase Phase 1
Start date November 2009
Completion date September 2013

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