NCT04149301|Completed
Subtalar Joint Morphology and Foot Deformity in Cerebral Palsy
Exploration of the Role of Subtalar Joint Morphology in the Development of Foot Deformity in Cerebral Palsy
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Exploration of the Role of Subtalar Joint Morphology in the Development of Foot Deformity in Cerebral Palsy
Sponsor study identifier
observational
23
1 country
1
Study Start
April 1, 2022
Actual (reported)Primary Completion
November 1, 2023
Actual (reported)Study Completion
December 31, 2023
Actual (reported)Cerebral palsy (CP) is a major cause of disability. Many children with CP develop foot deformities as they grow and these can become painful, adversely affecting their quality of life. The research team has previously studied foot morphology and biomechanics, including analysis of the subtalar joint and has successfully located the joint axis from MRI scans. In this project 25 children will be recruited (15 children with CP and 10 unimpaired control subjects). Each child will attend for a single visit, when they will undergo an MRI scan (with the foot loaded and unloaded) to measure the morphology of the ankle and foot, in particular the subtalar axis alignment. This has not been done before in CP. Each child will have an instrumented gait analysis and musculoskeletal modelling techniques will be used to study the biomechanical action of the external ground reaction force and internal muscle forces. The potential of these forces to rotate the subtalar joint and deform the foot will be assessed, resulting in new insights into potential mechanisms of foot deformity. The children will then be categorised to identify those most at risk, leading to personalised screening measures and treatment strategies in the future.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 30, 2019
Actual (reported)November 4, 2019
Actual (reported)April 1, 2022
Actual (reported)November 1, 2023
Actual (reported)December 31, 2023
Actual (reported)External loading on the subtalar joint (Measured as a moment in units of Nm)
This results from combining the gait analysis data (angles and forces) with the morphology from the MRI scans.
At baseline
Internal loading on the subtalar joint (Measured as a moment in units of Nm)
This results from combining the gait analysis data (angles and forces) with the morphology from the MRI scans, through a process of optimisation to distribute internal muscle forces.
At baseline
Children who do not have a problem with their walking ie children who do not have cerebral palsy
Children will have their walking measured in the gait laboratory to record their kinematics and kinetics along with electromyography (EMG) from key muscle groups.
Children with cerebral palsy and typically developing children aged 7-16 years.
ORLAU, RJAH Orthopaedic Hospital
Oswestry, Shropshire, SY10 7AG, United Kingdom
Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24.
O'Connell PA, D'Souza L, Dudeney S, Stephens M. Foot deformities in children with cerebral palsy. J Pediatr Orthop. 1998 Nov-Dec;18(6):743-7.
Parkinson KN, Dickinson HO, Arnaud C, Lyons A, Colver A; SPARCLE group. Pain in young people aged 13 to 17 years with cerebral palsy: cross-sectional, multicentre European study. Arch Dis Child. 2013 Jun;98(6):434-40. doi: 10.1136/archdischild-2012-303482. Epub 2013 Apr 20.
23 participants (actual enrollment reported by the registry).
First Submitted
October 30, 2019
First Posted
November 4, 2019
Study Start
April 1, 2022
Actual (reported)Study in Children Who Have Switched to Isosource Junior Mix Formula
The children will have two MRI scans taken - one with the foot loaded and one with no load applied.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Montefiori E, Modenese L, Di Marco R, Magni-Manzoni S, Malattia C, Petrarca M, Ronchetti A, de Horatio LT, van Dijkhuizen P, Wang A, Wesarg S, Viceconti M, Mazza C; MD-PAEDIGREE Consortium. An image-based kinematic model of the tibiotalar and subtalar joints and its application to gait analysis in children with Juvenile Idiopathic Arthritis. J Biomech. 2019 Mar 6;85:27-36. doi: 10.1016/j.jbiomech.2018.12.041. Epub 2019 Jan 9.
Modenese L, Montefiori E, Wang A, Wesarg S, Viceconti M, Mazza C. Investigation of the dependence of joint contact forces on musculotendon parameters using a codified workflow for image-based modelling. J Biomech. 2018 May 17;73:108-118. doi: 10.1016/j.jbiomech.2018.03.039. Epub 2018 Mar 30.
Parr WC, Chatterjee HJ, Soligo C. Calculating the axes of rotation for the subtalar and talocrural joints using 3D bone reconstructions. J Biomech. 2012 Apr 5;45(6):1103-7. doi: 10.1016/j.jbiomech.2012.01.011. Epub 2012 Jan 28.
Delp SL, Anderson FC, Arnold AS, Loan P, Habib A, John CT, Guendelman E, Thelen DG. OpenSim: open-source software to create and analyze dynamic simulations of movement. IEEE Trans Biomed Eng. 2007 Nov;54(11):1940-50. doi: 10.1109/TBME.2007.901024.
Primary Completion
November 1, 2023
Actual (reported)Study Completion
December 31, 2023
Actual (reported)Last Updated
February 29, 2024
Record last verified: 2024-02
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