Affordable prosthetics in the NHS: a Randomised Controlled Trial
Research type
Research Study
Full title
Affordable prosthetics in the NHS: Randomised Controlled Trial comparing affordable, multigrip prosthetics with standard NHS care.
IRAS ID
244661
Contact name
Abby Tabor
Contact email
Sponsor organisation
University of Bath
Duration of Study in the UK
1 years, 0 months, 17 days
Research summary
This research will involve that development of a successfully completed feasibility trial into a full randomised controlled trial of the same prosthetic device. The trial will be conducted over two NHS prosthetics services, including the Bristol Centre for Enablement (active collaboration from feasibility study) and the Specialised Ability Centre Manchester. We will recruit 16 participants aged between 11 and 18 years who have upper limb differences, either traumatic or congenital trans-radial amputation. Each participant will be randomised to one of two groups: the intervention group will receive a multi-grip myoelectric prosthetic (Hero arm) and the control group will receive standard care, which under current NHS commissioning will be a single grip myoelectric prosthetic at the same price point of the Hero arm. Each group will receive the usual care from clinicians including prosthetists and Occupational Therapy. They will undergo a period of training to ensure they are competent with the limb and they will then be asked to use the limb as little or as much as they would like over a period of 6 months.
Core research measures will be taken at the time of recruitment, following fitting, interim (3months) and at the conclusion of the trial. These measures will quantify function and psychosocial well-being as well as provide qualitative insights into each participants life. At the conclusion of the trial each participant will receive the limb that they have been provided to keep as their own with an associated warranty and maintenance policy.REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
18/LO/1228
Date of REC Opinion
6 Aug 2018
REC opinion
Further Information Favourable Opinion