SEM Glove study for spinal cord injury - v1
Research type
Research Study
Full title
Clinical trial of the Soft Extra Muscle Glove to assess orthotic and long-term functional gain following chronic incomplete tetraplegia: A longitudinal mixed methods study
IRAS ID
201786
Contact name
Denis Watson
Contact email
Sponsor organisation
Buckinghamshire Healthcare NHS Trust
ISRCTN Number
ISRCTN98677526
Duration of Study in the UK
1 years, 5 months, 11 days
Research summary
Hand function is essential for activities of daily living (ADL). People with spinal cord injury (SCI) can suffer from significant impaired hand functions. Conventional hand therapy is usually offered at the sub-acute stage of SCI but individuals with chronic SCI still experience significant impaired hand function which affects ADL and reduces quality of life.\n\nThis clinical investigation aim to test the benefit to chronic SCI individuals wearing a unique assistive device called the soft extra muscle (SEM) Glove. The SEM glove detects the voluntary effort to grasp an object and proportionally ‘strengthens’ the hand to complete the grasping function. This trial will test the benefits of the glove as an assistive device and as a rehabilitation device. First, as an assistive device the trial will test for the improvement in the quality of life while wearing the glove. Second, as a rehabilitation device, the project aims to test for improvement in hand function as a result of wearing the glove for 12 weeks at home. \nThe trial will be based at the National Spinal Injury Centre (NSIC), Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust. It will last for 18 week for each participant. During the first 12 weeks, the participants will wear the glove at their own homes but will visit the NSIC for assessments in week 0, 6, 12 and 18.\n \nEligible candidates for this project are those individuals with tetraplegia who have had SCI for at least one year.\n
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/1007
Date of REC Opinion
22 May 2016
REC opinion
Further Information Favourable Opinion