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COMPLETED
NCT05587010

Comparison of Gait in Different Support Conditions for Foot Drop

Sponsor: Dr Tim Exell

View on ClinicalTrials.gov

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 children and adolescents 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 barefoot (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.

Key Details

Gender

All

Age Range

4 Years - 17 Years

Study Type

OBSERVATIONAL

Enrollment

8

Start Date

2023-05-03

Completion Date

2024-05-10

Last Updated

2026-05-06

Healthy Volunteers

Not specified

Interventions

DEVICE

AFO

ankle foot orthosis

DEVICE

lycra sock

custom fitted lycra sock

DEVICE

OrthPed splint

novel compression splint

Locations (1)

University of Portsmouth

Portsmouth, Hampshire, United Kingdom