Comparison of Gait in Different Support Conditions for Foot Drop

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.

Study Overview

• Status: Completed
• Conditions: Foot Drop, Unspecified Foot
• Intervention / Treatment: Device: AFO; Device: lycra sock; Device: OrthPed splint

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO1 2ER
      • University of Portsmouth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; ankle foot orthosis; Device: lycra sock; custom fitted lycra sock; Device: OrthPed splint; novel compression splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recruitment as defined by the proportion of people with foot drop accepting the invitation to take part in the study	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint angles during walking gait	Differences in peak flexion, extension and range of motion of ankle, knee, hip and elbow angles during walking gait in different support conditions	6 months
Step length during walking gait	Differences in step length in different support conditions	6 months
Step frequency during walking gait	Differences in step frequency in different support conditions	6 months
Step velocity during walking gait	Differences in step velocity in different support conditions	6 months
Ground reaction force during walking gait	Differences in peak vertical, anterior, posterior, medial and lateral ground reaction forces during walking gait in different support conditions	6 months
Parent reported outcome measures of gait comfort and capacity	Family Impact Module of Pediatric Quality of Life Inventory (PedsQL) (Varni et al. (2005)	6 months
Patient reported outcome measures of gait comfort and capacity	Core Module of PedsQL (Varni et al. (2005) in different support conditions	6 months
Distance walked during 6-minute walk test	Distance walked during 6-minute walk test in different support conditions	6 months
Time achieved during Single Leg Stand test	Time achieved during Single Leg Stand test in different support conditions	6 months
Time achieved during Timed Up and Go test	Time achieved during Timed Up and Go test in different support conditions	6 months
Score achieved from Gait Assessment and Intervention Tool	Score achieved from Gait Assessment and Intervention Tool in different support conditions	6 months
Time taken to put on each device 1 handed	Time taken to put on each device 1 handed	6 months

Collaborators and Investigators

• Sponsor: Dr Tim Exell
• Collaborators: Portsmouth Hospitals NHS Trust; Solent NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Actual): May 10, 2024
• Study Completion (Actual): May 10, 2024

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: AFO; orthotic
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Mononeuropathies; Peroneal Neuropathies
• Other Study ID Numbers: Orthoped-UoP-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: processed outcome results will be shared through dissemination and publication of results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No