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New splint may help kids with foot drop walk better without weakening muscles

NCT ID NCT05587010

Knowledge-focused Sponsor: Dr Tim Exell Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how 8 children aged 4 to 17 with moderate foot drop walk when using different supports: barefoot, a Lycra sock, a rigid ankle-foot orthosis (AFO), and a new OrthoPed splint. The goal was to see if the OrthoPed splint allows more natural ankle movement while still preventing trips and falls. The study was small and focused on testing whether a larger trial is possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

8 people

The number who actually took part.

Started

May 2023

Finished

May 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

4 to 17 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

peroneal neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Foot drop, unspecified foot

Contacts and locations

Locations

  • University of Portsmouth

    Portsmouth, Hampshire, PO1 2ER, United Kingdom