Comparison of Gait in Different Support Conditions for Foot Drop

Dr Tim Exell

Status: Enrolling

Conditions: Foot Drop, Unspecified Foot

Treatments: Device: AFO; Device: OrthPed splint; Device: lycra sock

Study type: Observational

Funder types: Other

Identifiers

NCT05587010

Orthoped-UoP-22

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 4 - 17 years old
• Diagnosed moderate unilateral or bilateral foot drop
• Able to walk independently
• Minimum of 5 degrees of ankle dorsiflexion with or without gravity (Oxford Scale 2-4, Clarkson (2010))

Exclusion criteria

• Younger than 4 or older than 17 years old
• Severe foot drop that requires higher levels of support than elastic splint
• Unable to walk independently
• Visual impairment when corrected to not be able to see targets when walking
• Unable to understand and or cooperate with study protocol
• Health contraindications to exercise e.g. cardiac disease

Trial design

20 participants in 1 patient group

Foot drop

Description:

Participants living with foot drop in either foot. Orthotic support devices will be compared within this cohort to assess their impact on gait biomechanics and clinical outcomes

Treatment:

Device: lycra sock

Device: AFO

Device: OrthPed splint