Comparison of Gait in Different Support Conditions for Foot Drop

Recruiting

• Conditions: Foot Drop, Unspecified Foot
• Interventions: Device: AFO; Device: lycra sock; Device: OrthPed splint

• Registration Number: NCT05587010
• Lead Sponsor: Dr Tim Exell

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-17
• Study First Posted: 2022-10-19
• Study Start: 2023-05-03
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-03
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Foot drop	AFO	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
Foot drop	lycra sock	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
Foot drop	OrthPed splint	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

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

University of Portsmouth; 🇬🇧 Portsmouth, Hampshire, United Kingdom