Comparison of gait in different support conditions for foot drop V1
Research type
Research Study
Full title
Feasibility study investigating the effect of a novel splint device on gait characteristics of a paediatric population with footdrop
IRAS ID
317559
Contact name
Tim Exell
Contact email
Sponsor organisation
University of Portsmouth
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 20 days
Research summary
Foot drop is a complication accompanying a variety of conditions and refers to difficulty in lifting the foot upwards about the ankle. Foot drop is a common outcome of conditions including cerebral palsy, brain/spinal cord injury, muscular dystrophy, stroke and after chemotherapy. Foot drop can lead to trips and falls for the individual if the foot catches on the ground when walking, negatively impacting on independence and quality of life.
Approximately 46,720 children and adolescents in the UK have the above conditions and current treatment for individuals with foot drop include use of a lycra sock for those requiring low support and a rigid Ankle Foot Orthosis (AFO) for those requiring high support. The current problem is that all small children requiring more than low support of the lycra sock are fitted with an AFO, which can lead to muscles becoming weak over time as the AFO restricts almost all movement about the ankle.
This study will assess the use of a new device, the OrthoPed splint, in young people aged 4 - 17 years old who have moderate foot drop. The OrthoPed splint has been developed to be used as a long-term device and aims to reduce loss of strength by allowing more ankle function than an AFO.
This study aims to assess the feasibility of recruiting children and adolescents with foot drop into a study, collecting information on their movement and how well they walk when wearing different support devices for foot drop. Each person in the study will be measured when walking with no external support and when wearing an AFO, Lycra sock and the OrthoPed splint. This feasibility study will inform the design, management, and delivery of a future larger randomised, controlled, non-inferiority trial.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
23/YH/0004
Date of REC Opinion
11 Jan 2023
REC opinion
Favourable Opinion