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Completed

NCT Number: NCT05587010

Comparison of Gait in Different Support Conditions for Foot Drop

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.

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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Portsmouth

Portsmouth, Hampshire, PO1 2ER, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AFO

Device

ankle foot orthosis

lycra sock

Device

custom fitted lycra sock

OrthPed splint

Device

novel compression splint

Primary outcomes

  1. Recruitment as defined by the proportion of people with foot drop accepting the invitation to take part in the study

    Time frame: 6 months

Secondary outcomes

  1. Joint angles during walking gait

    Time frame: 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

  2. Step length during walking gait

    Time frame: 6 months

    Differences in step length in different support conditions

  3. Step frequency during walking gait

    Time frame: 6 months

    Differences in step frequency in different support conditions

  4. Step velocity during walking gait

    Time frame: 6 months

    Differences in step velocity in different support conditions

  5. Ground reaction force during walking gait

    Time frame: 6 months

    Differences in peak vertical, anterior, posterior, medial and lateral ground reaction forces during walking gait in different support conditions

  6. Parent reported outcome measures of gait comfort and capacity

    Time frame: 6 months

    Family Impact Module of Pediatric Quality of Life Inventory (PedsQL) (Varni et al. (2005)

  7. Patient reported outcome measures of gait comfort and capacity

    Time frame: 6 months

    Core Module of PedsQL (Varni et al. (2005) in different support conditions

  8. Distance walked during 6-minute walk test

    Time frame: 6 months

    Distance walked during 6-minute walk test in different support conditions

  9. Time achieved during Single Leg Stand test

    Time frame: 6 months

    Time achieved during Single Leg Stand test in different support conditions

  10. Time achieved during Timed Up and Go test

    Time frame: 6 months

    Time achieved during Timed Up and Go test in different support conditions

  11. Score achieved from Gait Assessment and Intervention Tool

    Time frame: 6 months

    Score achieved from Gait Assessment and Intervention Tool in different support conditions

  12. Time taken to put on each device 1 handed

    Time frame: 6 months

    Time taken to put on each device 1 handed

Sponsors and collaborators

Lead sponsor

Dr Tim Exell

Other

Collaborators

  • Portsmouth Hospitals NHS Trust
  • Solent NHS Trust

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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