Subtalar Joint Morphology and Foot Deformity in Cerebral Palsy

NCT ID: NCT04149301

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Typically developing children

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

3D gait analysis

Intervention Type 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.

MRI scan

Intervention Type 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 without foot deformity

3D gait analysis

Intervention Type 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.

MRI scan

Intervention Type 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

3D gait analysis

Intervention Type 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.

MRI scan

Intervention Type 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 severe foot deformity

3D gait analysis

Intervention Type 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.

MRI scan

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

MRI scan

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Keele University

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

University of Aberdeen

OTHER

Sponsor Role collaborator

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ORLAU, RJAH Orthopaedic Hospital

Oswestry, Shropshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23346889 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9821129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23606716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30704761 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29673935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22284429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18018689 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RL1795

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.