University of Portsmouth
Portsmouth, Hampshire, PO1 2ER, United Kingdom
NCT Number: NCT05587010
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.
Looking for future studies?
Notify Me4 year–17 year
All sexes
Observational
Portsmouth, Hampshire, PO1 2ER, United Kingdom
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ankle foot orthosis
custom fitted lycra sock
novel compression splint
Time frame: 6 months
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
Time frame: 6 months
Differences in step length in different support conditions
Time frame: 6 months
Differences in step frequency in different support conditions
Time frame: 6 months
Differences in step velocity in different support conditions
Time frame: 6 months
Differences in peak vertical, anterior, posterior, medial and lateral ground reaction forces during walking gait in different support conditions
Time frame: 6 months
Family Impact Module of Pediatric Quality of Life Inventory (PedsQL) (Varni et al. (2005)
Time frame: 6 months
Core Module of PedsQL (Varni et al. (2005) in different support conditions
Time frame: 6 months
Distance walked during 6-minute walk test in different support conditions
Time frame: 6 months
Time achieved during Single Leg Stand test in different support conditions
Time frame: 6 months
Time achieved during Timed Up and Go test in different support conditions
Time frame: 6 months
Score achieved from Gait Assessment and Intervention Tool in different support conditions
Time frame: 6 months
Time taken to put on each device 1 handed
Dr Tim Exell
Other
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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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