Feasibility of prolonged stretch RCT in severe brain injury
Research type
Research Study
Full title
Feasibility study investigating the randomisation of adults unable to consent to receive serial casting or splinting following hamstring botulinum toxin treatment for spasticity and contracture.
IRAS ID
283550
Contact name
Teresa Clark
Contact email
Sponsor organisation
Royal Hospital for Neurodisability
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Following a severe brain injury, some people live for decades in a highly dependent state reliant on others for all decision making and care. They suffer continual physical deterioration for the remainder of their lifespan. Spasticity (uncontrollable muscle contraction) affects a significant number of people with brain injury and is associated with muscle contracture (irreversible muscle shortening) and postural deformity. Contractures occur when a muscle is held in a shortened position for a prolonged time. The severely disabled are more likely to experience contracture, as they cannot move their own bodies or express their needs. Defining cost effective ways to reduce their contracture risk is a continual priority.
Current standard treatment for spasticity and contracture is botulinum toxin and prolonged stretch of the affected muscle – provided by a splint (removable and worn for several hours per day) or serial casting (a non-removable splint worn continuously for several days). There is currently no evidence to suggest which stretch intervention is best for long term contracture management, how the outcomes of these interventions differ in those with severe brain injuries who are unlikely to recover, and what should guide our best interests decision making for those who are unable to consent to treatment. Due to the chronic nature of their condition, the prognosis and outcomes of these individuals are very different from those with higher cognitive or physical function and need to be examined separately.
Answering these questions would require a powered randomised experimental study able to compare interventions. Examining the current knowledge base, several significant challenges to research design could place this study at risk of failure.
This feasibility study aims to investigate the key feasibility threats to running a randomised controlled trial, including; acceptability of randomisation, safety of implementation and protocol feasibility.REC name
London - Queen Square Research Ethics Committee
REC reference
20/LO/1148
Date of REC Opinion
2 Dec 2020
REC opinion
Further Information Favourable Opinion