Comparison of Gait in Different Support Conditions for Foot Drop

NCT05587010 | Completed

• 1 other identifier: Orthoped-UoP-22
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Foot Drop, Unspecified Foot

Keywords

orthotic; AFO

Outcome Measures

Primary Outcomes (1)

• Recruitment as defined by the proportion of people with foot drop accepting the invitation to take part in the study

  6 months

Secondary Outcomes (12)

• Joint angles during walking gait

  6 months

• Step length during walking gait

  6 months

• Step frequency during walking gait

  6 months

• Step velocity during walking gait

  6 months

• Ground reaction force during walking gait

  6 months

Study Arms (1)

Foot drop

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

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

Interventions

AFO DEVICE

ankle foot orthosis

Foot drop

lycra sock DEVICE

custom fitted lycra sock

Foot drop

OrthPed splint DEVICE

novel compression splint

Foot drop

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients under paediatric physiotherapy care suffering from moderate foot drop. Patients will be identified through physiotherapy care for foot drop. As the OrthoPed splint is designed for use with moderate foot drop patients, we will only study patients identified by the physiotherapy team as having moderate foot drop, defined as a minimum of 5 degrees of dorsiflexion with or without gravity (Oxford Scale 2-4), and suitable for using the OrthoPed splint. The splint is aimed for use in children and adolescents aged between 2 - 17 Years but due to the need to follow instructions and understand the requirements of the study, we will only study children and adolescents aged 4-17 Years.

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Tim Exell: lead
• Portsmouth Hospitals NHS Trust: collaborator
• Solent NHS Trust: collaborator

Study Sites (1)

University of Portsmouth

Portsmouth, Hampshire, PO1 2ER, United Kingdom

Location

MeSH Terms

Conditions

Peroneal Neuropathies

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Lecturer inn Biomechanics and Rehabilitation Science

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 19, 2022
• Study Start: May 3, 2023
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)