Foot Drop, Unspecified FootNCT05587010
Comparison of Gait in Different Support Conditions for Foot Drop
An observational study of Foot Drop, Unspecified Foot, run by Dr Tim Exell at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Foot Drop, Unspecified Foot
- What is being tested?
- AFO, lycra sock and OrthPed splint
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 May 2023to 10 May 2024
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- Child
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.
Who may be able to join
- 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))
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Portsmouth
Portsmouth, Hampshire, PO1 2ER
About this study
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.
Read more
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.
- Conditions
- Foot Drop, Unspecified Foot
- Being tested
- AFO, lycra sock, OrthPed splint
- Keywords
- orthotic, AFO
- Medical subject headings
- Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFODevice
ankle foot orthosis
lycra sockDevice
custom fitted lycra sock
OrthPed splintDevice
novel compression splint
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: AFO; Device: lycra sock; Device: OrthPed splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment as defined by the proportion of people with foot drop accepting the invitation to take part in the study
Measured: 6 months
Secondary outcomes (12)
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
Measured: 6 months
Step length during walking gait
Differences in step length in different support conditions
Measured: 6 months
Step frequency during walking gait
Differences in step frequency in different support conditions
Measured: 6 months
Step velocity during walking gait
Differences in step velocity in different support conditions
Measured: 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
Measured: 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)
Measured: 6 months
Patient reported outcome measures of gait comfort and capacity
Core Module of PedsQL (Varni et al. (2005) in different support conditions
Measured: 6 months
Distance walked during 6-minute walk test
Distance walked during 6-minute walk test in different support conditions
Measured: 6 months
Time achieved during Single Leg Stand test
Time achieved during Single Leg Stand test in different support conditions
Measured: 6 months
Time achieved during Timed Up and Go test
Time achieved during Timed Up and Go test in different support conditions
Measured: 6 months
Score achieved from Gait Assessment and Intervention Tool
Score achieved from Gait Assessment and Intervention Tool in different support conditions
Measured: 6 months
Time taken to put on each device 1 handed
Time taken to put on each device 1 handed
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start3 May 2023
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Drop, Unspecified FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Dr Tim Exell
- Sponsor type
- University, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust, Solent NHS Trust
- Responsible party
- Sponsor-investigator, Dr Tim Exell, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587010
- Sponsor's protocol ID
- Orthoped-UoP-22
- Status last verified
- Apr 2026
- First submitted
- 11 Oct 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: processed outcome results will be shared through dissemination and publication of results
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gait in Different Support Conditions for Foot Drop
- ClinicalTrials.gov ID
- NCT05587010
- Acronym / sponsor ID
- Orthoped-UoP-22
- Conditions
- Foot Drop, Unspecified Foot
- Keywords
- orthotic, AFO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dr Tim ExellUniversity, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust, Solent NHS Trust
- Study start
- 3 May 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foot drop | – | Device: AFO, Device: lycra sock, Device: OrthPed splintParticipants 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 |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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))
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFOankle foot orthosis | Device | Foot drop |
| lycra sockcustom fitted lycra sock | Device | Foot drop |
| OrthPed splintnovel compression splint | Device | Foot drop |
Primary outcome
Recruitment as defined by the proportion of people with foot drop accepting the invitation to take part in the study
Time frame: 6 months
12 secondary outcomes
Joint angles during walking gait
Time frame: 6 months
Step length during walking gait
Time frame: 6 months
Step frequency during walking gait
Time frame: 6 months
Step velocity during walking gait
Time frame: 6 months
Ground reaction force during walking gait
Time frame: 6 months
Parent reported outcome measures of gait comfort and capacity
Time frame: 6 months
Patient reported outcome measures of gait comfort and capacity
Time frame: 6 months
Distance walked during 6-minute walk test
Time frame: 6 months
Time achieved during Single Leg Stand test
Time frame: 6 months
Time achieved during Timed Up and Go test
Time frame: 6 months
Score achieved from Gait Assessment and Intervention Tool
Time frame: 6 months
Time taken to put on each device 1 handed
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. processed outcome results will be shared through dissemination and publication of results
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foot Drop, Unspecified Foot, run by Dr Tim Exell at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment as defined by the proportion of people with foot drop accepting the invitation to take part in the study (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.