Clinical trial NCT05587010: Comparison of Gait in Different Support Conditions for Foot Drop
Official title: Comparison of Gait in Different Support Conditions for Foot Drop
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Foot Drop, Unspecified Foot
Keywords: orthotic
AFO
Lead sponsor: University of Portsmouth
Sponsor class: OTHER
Collaborators: name: Portsmouth Hospitals NHS Trust
name: Solent NHS Trust
First posted: 2022-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


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

Primary outcomes:
measure: Recruitment as defined by the proportion of people with foot drop accepting the invitation to take part in the study
timeFrame: 6 months
Secondary outcomes:
measure: Joint angles during walking gait
timeFrame: 6 months
measure: Step length during walking gait
timeFrame: 6 months
measure: Step frequency during walking gait
timeFrame: 6 months
measure: Step velocity during walking gait
timeFrame: 6 months
measure: Ground reaction force during walking gait
timeFrame: 6 months
measure: Parent reported outcome measures of gait comfort and capacity
timeFrame: 6 months
measure: Patient reported outcome measures of gait comfort and capacity
timeFrame: 6 months
measure: Distance walked during 6-minute walk test
timeFrame: 6 months
measure: Time achieved during Single Leg Stand test
timeFrame: 6 months
measure: Time achieved during Timed Up and Go test
timeFrame: 6 months
measure: Score achieved from Gait Assessment and Intervention Tool
timeFrame: 6 months
measure: Time taken to put on each device 1 handed
timeFrame: 6 months
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: University of Portsmouth
state: Hampshire
Study officials:
References: