Subtalar Joint Morphology and Foot Deformity in Cerebral Palsy

NCT04149301 | Completed

• 1 other identifier: RL1795
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy

Keywords

musculoskeletal modelling; gait analysis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Typically developing children

Children who do not have a problem with their walking ie children who do not have cerebral palsy

Diagnostic Test: 3D gait analysis; Diagnostic Test: MRI scan

Children with cerebral palsy without foot deformity

Diagnostic Test: 3D gait analysis; Diagnostic Test: MRI scan

Children with cerebral palsy with mild foot deformity

Diagnostic Test: 3D gait analysis; Diagnostic Test: MRI scan

Children with cerebral palsy with severe foot deformity

Diagnostic Test: 3D gait analysis; Diagnostic Test: MRI scan

Interventions

3D gait analysis DIAGNOSTIC_TEST

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 with mild foot deformity; Children with cerebral palsy with severe foot deformity; Children with cerebral palsy without foot deformity; Typically developing children

MRI scan DIAGNOSTIC_TEST

The children will have two MRI scans taken - one with the foot loaded and one with no load applied.

Children with cerebral palsy with mild foot deformity; Children with cerebral palsy with severe foot deformity; Children with cerebral palsy without foot deformity; Typically developing children

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with cerebral palsy and typically developing children aged 7-16 years.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: lead
• Keele University: collaborator
• Imperial College London: collaborator
• University of Oxford: collaborator
• University of Aberdeen: collaborator

Study Sites (1)

ORLAU, RJAH Orthopaedic Hospital

Oswestry, Shropshire, SY10 7AG, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 23346889 BACKGROUND

• 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.

  PMID: 9821129 BACKGROUND

• 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.

  PMID: 23606716 BACKGROUND

• 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.

  PMID: 30704761 BACKGROUND

• 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.

  PMID: 29673935 BACKGROUND

• 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.

  PMID: 22284429 BACKGROUND

• 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.

  PMID: 18018689 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 4, 2019
• Study Start: April 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 31, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

GB (1)