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Clinical Trials/NCT05587010
NCT05587010
Recruiting
Not Applicable

Comparison of Gait in Different Support Conditions for Foot Drop

Dr Tim Exell1 site in 1 country20 target enrollmentMay 3, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Foot Drop, Unspecified Foot
Sponsor
Dr Tim Exell
Enrollment
20
Locations
1
Primary Endpoint
Recruitment as defined by the proportion of people with foot drop accepting the invitation to take part in the study
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
May 3, 2023
End Date
May 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Dr Tim Exell
Responsible Party
Sponsor Investigator
Principal Investigator

Dr Tim Exell

Senior Lecturer inn Biomechanics and Rehabilitation Science

University of Portsmouth

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Step length during walking gait(6 months)
  • Time achieved during Single Leg Stand test(6 months)
  • Score achieved from Gait Assessment and Intervention Tool(6 months)
  • Step frequency during walking gait(6 months)
  • Time taken to put on each device 1 handed(6 months)
  • Ground reaction force during walking gait(6 months)
  • Patient reported outcome measures of gait comfort and capacity(6 months)
  • Distance walked during 6-minute walk test(6 months)
  • Step velocity during walking gait(6 months)
  • Parent reported outcome measures of gait comfort and capacity(6 months)
  • Joint angles during walking gait(6 months)
  • Time achieved during Timed Up and Go test(6 months)

Study Sites (1)

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