An observational study in Foot Drop, Unspecified Foot, sponsored by Dr Tim Exell. Completed at 1 site in United Kingdom. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Dr Tim Exell · Observational
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.
41 studies on the registry are indexed under Peroneal Neuropathies; 9 are open to participants now.
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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.
Exclusion Criteria:
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
ankle foot orthosis
custom fitted lycra sock
novel compression splint
Recruitment as defined by the proportion of people with foot drop accepting the invitation to take part in the study
Time frame: 6 months
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
Time frame: 6 months
Step length during walking gait
Differences in step length in different support conditions
Time frame: 6 months
Step frequency during walking gait
Differences in step frequency in different support conditions
Time frame: 6 months
Step velocity during walking gait
Differences in step velocity in different support conditions
Time frame: 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
Time frame: 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)
Time frame: 6 months
Patient reported outcome measures of gait comfort and capacity
Core Module of PedsQL (Varni et al. (2005) in different support conditions
Time frame: 6 months
Distance walked during 6-minute walk test
Distance walked during 6-minute walk test in different support conditions
Time frame: 6 months
Time achieved during Single Leg Stand test
Time achieved during Single Leg Stand test in different support conditions
Time frame: 6 months
Time achieved during Timed Up and Go test
Time achieved during Timed Up and Go test in different support conditions
Time frame: 6 months
Score achieved from Gait Assessment and Intervention Tool
Score achieved from Gait Assessment and Intervention Tool in different support conditions
Time frame: 6 months
Time taken to put on each device 1 handed
Time taken to put on each device 1 handed
Time frame: 6 months
Plan to share: No — processed outcome results will be shared through dissemination and publication of results
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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