Subtalar Joint Morphology and Foot Deformity in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Exploration of the Role of Subtalar Joint Morphology in the Development of Foot Deformity in Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04149301
• Other study ID #: RL1795
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Cerebral palsy (CP) is a common cause of childhood disability with an incidence of 2.11 per 1000 live births. Children with CP often develop problems with their feet during growth, with a reported prevalence of foot deformity of 86% in a group of 66 diplegic children. Deformities may occur in the ankle joint, subtalar joint (the joint below the ankle) and/or the foot itself. The European SPARCLE study reported that 54% of children with CP experienced pain in the previous week, which was associated with a poorer quality of life. This rose to 75% in a subsequent study of adolescents. The most common place for children to experience pain is in the feet, especially for the more mobile children. Clinical experience is that deformed feet are challenging to manage with splints. Biomechanical changes in the ankle and foot affect the whole leg and a sudden deterioration in gait often follows, for example the development of a crouch gait pattern. Several mechanisms are proposed for the development of foot deformity, including calf muscle tightness, muscle imbalance, bony subluxation and collapse of the longitudinal arch. It is difficult to separate cause and effect as phenomena occur concurrently. Previously the research team have examined the morphology of the foot in detail using imaging techniques and gait analysis. To date no one has conducted similar studies looking at the subtalar joint in cerebral palsy and the orientation of the axis in this condition is currently unknown. Participants in this research (typically developing children and children with cerebral palsy) will only need to attend on a single occasion. They will spend around half a day in the hospital, with measurements being taken in two departments:- MRI scans: The children will have MRI scans taken of one leg. This will be done twice, firstly with the limb unloaded and then with a load applied to the foot. The child will have MRI opaque markers attached to bony landmarks on the skin before the scans are taken. Gait analysis: The children will attend the gait laboratory. Here they will be asked to wear shorts and a T shirt or crop top. A simple orthopaedic examination will be carried out to measure their legs and joints. They will then have retroreflective markers and electromyography (EMG) sensors attached to their legs and they will be asked to walk up and down the laboratory whilst their walking pattern is recorded. The record will include video images, 3D tracking of the marker positions and muscle signals from the EMG. At the end of the data collection they will be free to leave and their participation in the study will end. MRI scans will be segmented using Mimics (Materialise, Belgium) software to obtain bone geometries. As demonstrated in previous studies unloaded MRI scans allow high quality reconstruction of foot bone geometries, suitable for generating multi-segmental models of the foot and tibia in adult and paediatric populations. Subject-specific ankle and foot musculoskeletal models will be produced from the reconstructed patient's bone geometries, including personalized muscle attachments, derived from the MRI scans and subject-specific tibiotalar and subtalar joint axes, identified by fitting appropriate analytical shapes (spheres and cylinders) to the articular surfaces. The individual dynamic models will be validated by comparing their configuration in the stance phase of walking against the loaded MRI scans. External joint moments due to the action of ground reaction force will be computed using an inverse dynamics analysis implemented in OpenSim, while the contribution of the calf muscles to the internal joint moments will be estimated by computing the muscles' moment arms with respect to foot joint axes. This study will produce the first pilot data of static and dynamic subtalar morphology in children with cerebral palsy. The research team hope to identify potential mechanisms of deformity which can be used to categorise feet and inform treatment, prior to designing a future interventional clinical trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 31, 2023
• Est. primary completion date: November 1, 2023
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

Inclusion Criteria:

• Able to walk independently (for CP children GMFCS level 1 or 2)
• Able to understand and comply with experimental protocols

Exclusion Criteria:

• Any contraindications to MRI scanning eg pronounced startle reflexes or metal implants.
• Any orthopaedic surgery in the last 6 months, or any previous bony surgery to the ankle of foot.

Related Conditions & MeSH terms

• Cerebral Palsy
• Foot Deformities

Intervention

Diagnostic Test:
• 3D gait analysis
Children will have their walking measured in the gait laboratory to record their kinematics and kinetics along with electromyography (EMG) from key muscle groups.
• MRI scan
The children will have two MRI scans taken - one with the foot loaded and one with no load applied.

Locations

Country	Name	City	State
United Kingdom	ORLAU, RJAH Orthopaedic Hospital	Oswestry	Shropshire

Sponsors (5)

Lead Sponsor	Collaborator
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust	Imperial College London, Keele University, University of Aberdeen, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Dev Med Child Neurol. 2016 Mar;58(3):316. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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