Cerebral PalsyNCT04149301
Subtalar Joint Morphology and Foot Deformity in Cerebral Palsy
An observational study of Cerebral Palsy, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- 3D gait analysis and MRI scan
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- Child
Study population: Children with cerebral palsy and typically developing children aged 7-16 years.
Who may be able to join
- Able to walk independently (for CP children GMFCS level 1 or 2)
- Able to understand and comply with experimental protocols
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
ORLAU, RJAH Orthopaedic Hospital
Oswestry, Shropshire, SY10 7AG
About this study
Official title: Exploration of the Role of Subtalar Joint Morphology in the Development of Foot Deformity in Cerebral Palsy
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.
Read more
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.
Read the detailed 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.
- Conditions
- Cerebral Palsy
- Being tested
- 3D gait analysis, MRI scan
- Keywords
- musculoskeletal modelling, gait analysis
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D gait analysisDiagnostic 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 scanDiagnostic test
The children will have two MRI scans taken - one with the foot loaded and one with no load applied.
| Study group | Role | What they receive |
|---|---|---|
| Typically developing children | Children who do not have a problem with their walking ie children who do not have cerebral palsy Receives: Diagnostic Test: 3D gait analysis; Diagnostic Test: MRI scan | |
| Children with cerebral palsy without foot deformity | Not described Receives: Diagnostic Test: 3D gait analysis; Diagnostic Test: MRI scan | |
| Children with cerebral palsy with mild foot deformity | Not described Receives: Diagnostic Test: 3D gait analysis; Diagnostic Test: MRI scan | |
| Children with cerebral palsy with severe foot deformity | Not described Receives: Diagnostic Test: 3D gait analysis; Diagnostic Test: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 Apr 2022
- Primary completion1 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Collaborators
- Keele University, Imperial College London, University of Oxford, University of Aberdeen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149301
- Sponsor's protocol ID
- RL1795
- Status last verified
- Feb 2024
- First submitted
- 30 Oct 2019
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will only be shared within the research team during the research study, though anonymised data may be released with publication.
Publications
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.
PubMed 23346889O'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.
PubMed 9821129Parkinson 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.
PubMed 23606716Montefiori 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.
PubMed 30704761Modenese 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.
PubMed 29673935Parr 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.
PubMed 22284429Delp 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.
PubMed 18018689
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Role of Subtalar Joint Morphology in the Development of Foot Deformity in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04149301
- Acronym / sponsor ID
- RL1795
- Conditions
- Cerebral Palsy
- Keywords
- musculoskeletal modelling, gait analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Collaborators
- Keele University, Imperial College London, University of Oxford, University of Aberdeen
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Typically developing children | – | Diagnostic Test: 3D gait analysis, Diagnostic Test: MRI scanChildren who do not have a problem with their walking ie children who do not have cerebral palsy |
| 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 |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Children with cerebral palsy and typically developing children aged 7-16 years.
Key inclusion criteria (2 listed)
- Able to walk independently (for CP children GMFCS level 1 or 2)
- Able to understand and comply with experimental protocols
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D gait analysisChildren will have their walking measured in the gait laboratory to record their kinematics and kinetics along with electromyography (EMG) from key muscle groups. | Diagnostic test | 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 scanThe children will have two MRI scans taken - one with the foot loaded and one with no load applied. | Diagnostic test | 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 |
Primary outcome
External loading on the subtalar joint (Measured as a moment in units of Nm)
Time frame: At baseline
This results from combining the gait analysis data (angles and forces) with the morphology from the MRI scans.
Internal loading on the subtalar joint (Measured as a moment in units of Nm)
Time frame: At baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 23346889Oskoui 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.
- Background: PubMed 9821129O'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.
- Background: PubMed 23606716Parkinson 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.
- Background: PubMed 30704761Montefiori 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.
- Background: PubMed 29673935Modenese 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.
- Background: PubMed 22284429Parr 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.
- Background: PubMed 18018689Delp 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.
- Individual participant dataSharing planned: Undecided. Data will only be shared within the research team during the research study, though anonymised data may be released with publication.
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
External loading on the subtalar joint (Measured as a moment in units of Nm) (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04149301, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.