Comparison of Gait in Different Support Conditions for Foot Drop

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Gait in Different Support Conditions for Foot Drop

Conditions
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Foot Drop, Unspecified Foot

Intervention / Treatment
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* Device: AFO
* Device: lycra sock
* Device: OrthPed splint


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Foot drop<br>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<br>* ankle foot orthosis<br>Device: lycra sock<br>* custom fitted lycra sock<br>Device: OrthPed splint<br>* novel compression splint<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orthotic, AFO