Equinus DeformityEQUINUSNCT02814786
Dynamic Evaluation of Ankle Joint and Muscle Mechanics in Children With Spastic Equinus Deformity Due to Cerebral Palsy
A study testing MRI scanner and Gait analysis in people with Equinus Deformity, run by University Hospital, Brest at 1 site in France.
Trial summary
This research will lead to the first evaluation of intrinsic and dynamic joint and muscle mechanics of equinus in cerebral palsy. It would provide a direct cause and effect relationship between equinus and bone deformity. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Equinus Deformity
- What is being tested?
- MRI scanner and Gait analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2016to 31 Dec 2020
- Phase
- Interventional
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Equinus cohort inclusion criteria:
- children between 7 and 14 years old
- with unilateral CP and GMFCS score of I or II
- with the presence of fixed equinus defined as a fixed limitation of dorsiflexion inferior to 0°
Control cohort inclusion criteria:
- age and gender matched to equinus cohort
- no history of lower limb musculo-skeletal injury in past 6 months
- no history of lower limb musculoskeletal surgery in past six months
- no contraindications to MRI
Equinus cohort exclusion criteria:
- history of lower limb musculo-skeletal surgery
- botulinum toxin injection in past 6 months
- contraindications to MRI
- Uncooperative patient who refused to sign the informed consent
- Patient unable to understand the protocol, under guardianship
- Patients not affiliated to the Social Security.
Control cohort exclusion criteria:
- Uncooperative patient who refused to sign the informed consent
- Patient unable to understand the protocol, under guardianship
- Patients not affiliated to the Social Security.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo Dynamic Evaluation of Ankle Joint and Muscle Mechanics in Children With Spastic Equinus Deformity Due to Cerebral Palsy: Implications for Recurrent Equinus.
This research will lead to the first evaluation of intrinsic and dynamic joint and muscle mechanics of equinus in cerebral palsy. It would provide a direct cause and effect relationship between equinus and bone deformity. Mechanical insights to the pathophysiology of the targeted muscles will lead to better understanding and, thus, to a better medical and surgical management of equinus deformity. Secondary aim will provide an important insight whether key gait parameters can be exclusively relied upon for surgical treatment planning and evaluation. In a medium-term perspective, depending upon the results of this study, dynamic MRI of the ankle joint may serve as a guiding tool for fixed equinus surgery in case of cerebral palsy.
Read the detailed description
Equinus is the most common deformity in children with cerebral palsy. Spastic equinus is typically defined as the inability to dorsa-flex the foot above plantigrade, with the hindfoot in neutral position and the knee in extended position. Approximately 90% of the deformities in cerebral palsy occur in the ankle and foot region alone with the incidence of equinus being around 75%. Spastic equinus exhibits poor muscle control and muscle weakness around ankle and foot, resulting in bone deformities and gait abnormalities. Non-operative conservative management of equinus is typically undertaken up until 8 years in order to prevent recurrent equinus or overcorrection by avoiding high-growth phase of child's development for surgical intervention. Despite these precautions, long term follow-up studies report up to 48% of recurrence rate post-surgery. Recurrence surgery not only increases the economic burden on the society but also has a debilitating impact on children and their families. Previous research is focused on extrinsic risk factors such as CP type, demographic parameters, and clinical gait parameters for surgical recurrence and none assessed the dynamic impact of intrinsic bone deformity on ankle joint and muscle mechanics. A primary reason for this recurrence could be a lack of understanding of bone deformity that might be forcing the child to adapt altered ankle joint and muscle mechanics (bone kinematics, cartilage contact parameters, muscle strain) during dynamic activities. In fact, the surgical treatment of fixed equinus does not consider any bone corrections and focus on muscle release or lengthening only. Being a dynamic pathology, it is critical to understand the in vivo effect of weak ankle joint musculature on joint mechanics and the resultant bone deformity. However, no such efforts have been made so far in the literature. With the advent of technology, researchers have developed and validated dynamic magnetic resonance imaging techniques to analyze in vivo muscle and joint mechanics. Processing this data enables researchers to analytically track bones without having to identify specific points or anatomical landmarks and thus provides the ability to track muscle motion as well as skeletal motion. Thus properties such as bone kinematics, cartilage contact mechanics, musculotendon moment arms, muscle strain and tendon strain are available from these analyses. These techniques can be successfully employed in equinus research to evaluate ankle joint and muscle mechanics in vivo.
- Conditions
- Equinus Deformity
- Being tested
- MRI scanner, Gait analysis
- Medical subject headings
- Equinus Deformity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scannerRadiation
Also called MRI data on pediatric ankle joint
This examination is divided in 2 parts:
- Passive movement: after placing the ankle joint in the fixture, each child will be asked to relax the lower limb musculature and then the fixture will be cyclically moved by a technician at a speed which does not trigger spasticity.
- Active movement: no technician will be present and children will be asked to perform voluntary plantar-dorsiflexion between the extreme positions on the beat of the metronome.
Gait analysisOther
Also called Gait evaluation
For gait evaluation, each child will undergo a lower limb gait analysis in a motion analysis laboratory equipped with Camera system and 4 AMTI force plates Sixteen reflective markers will be placed on the lower limbs. Each child will walk bare foot and gait will be recorded during each of five 10-meter trials. A velocity of 1 m/s (+/- 10%) will be imposed using a stop watch in order to eliminate the influence of velocity on gait kinematics and kinematics while comparing across subjects. Each child will be allowed to walk for 5 minutes after attaching the reflective markers and before recording the gait data. In addition to the joint kinematics, joint powers and moments will be computed using an inverse dynamics method.
| Study group | Role | What they receive |
|---|---|---|
| Equinus cohort | Experimental | 15 childrens who have a fixed equinus defined as a fixed limitation of dorsiflexion inferior to 0°.
Interventions: MRI scanner and gait analysis Receives: Radiation: MRI scanner; Other: Gait analysis |
| Control cohort | Experimental | In this cohort, there will be 15 childrens with age and gender matched to equinus cohort and with no history of lower limb musculo-skeletal injury in past 6 months.
Interventions: MRI scanner and gait analysis Receives: Radiation: MRI scanner; Other: Gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Talocrural joint flexion, pronation, and internal rotations
Talocrural (talus relative to tibia) joint rotations and translations will be compared between two cohorts.
Measured: One year
Subtalar joint flexion, pronation, and internal rotations
Subtalar (calcaneus relative to talus) joint rotations and translations will be compared between two cohorts.
Measured: one year
Achilles tendon moment arm (MAAT)
MAAT is defined as a perpendicular 3D distance between Achilles' tendon line of action and the Medial-lateral Calcaneal axis. Using calcaneal kinematics, MAAT value for each time frame will be quantified and compared between two cohorts.
Measured: one year
Secondary outcomes (7)
Ankle joint kinematics (joint angles) during walking
Walking gait parameters (ankle, knee, and hip joint angles) will be correlated with primary outcome measures
Measured: one year
Knee joint kinematics (joint angles) during walking
Walking gait parameters (ankle, knee, and hip joint angles) will be correlated with primary outcome measures
Measured: one year
Hip joint kinematics (joint angles) during walking
Walking gait parameters (ankle, knee, and hip joint angles) will be correlated with primary outcome measures
Measured: one year
Talocrural joint contact area
Joint contact mechanics measures and will be compared between cohorts.
Measured: one year
Talocrural joint contact centroid location
Joint contact mechanics measures and will be compared between cohorts.
Measured: one year
Subtalar joint contact area
Joint contact mechanics measures and will be compared between cohorts.
Measured: one year
Subtalar joint contact centroid location
Joint contact mechanics measures and will be compared between cohorts.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start8 Sep 2016
- Primary completion18 Apr 2019
- Study completion31 Dec 2020
Why it stopped: lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Equinus DeformityStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814786
- Sponsor's protocol ID
- RB15-159 EQUINUS
- Acronym
- EQUINUS
- Status last verified
- Apr 2025
- First submitted
- 10 Feb 2016
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Makki K, Borotikar B, Garetier M, Acosta O, Brochard S, Ben Salem D, Rousseau F. 4D in vivo quantification of ankle joint space width using dynamic MRI. Annu Int Conf IEEE Eng Med Biol Soc. 2019 Jul;2019:2115-2118. doi: 10.1109/EMBC.2019.8856687.
PubMed 31946318Cheng, Y., Bailly, R., Borotikar, B., Scavinner-Dorval, C., Fouquet, B., Salem, D. B., ... & Rousseau, F. (2023, April). Morphological analysis of ankle shorts bones of children with cerebral palsy: a comparative study. In Medical Imaging 2023: Image Processing (Vol. 12464, pp. 584-588). SPIE.
Scavinner-Dorval, C., Bailly, R., Borotikar, B., Brochard, S., Salem, D. B., & Rousseau, F. (2024, April). Analysis of disentangled representation learning for high-resolution dynamic MRI synthesis. In Medical Imaging 2024: Image Processing (Vol. 12926, pp. 694-699). SPIE
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Dynamic Evaluation of Ankle Joint and Muscle Mechanics in Children With Spastic Equinus Deformity Due to Cerebral Palsy: Implications for Recurrent Equinus.
- ClinicalTrials.gov ID
- NCT02814786
- Acronym / sponsor ID
- EQUINUS / RB15-159 EQUINUS
- Conditions
- Equinus Deformity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusion
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 8 Sep 2016 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Jun 2016 (estimated)
- 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.
This research will lead to the first evaluation of intrinsic and dynamic joint and muscle mechanics of equinus in cerebral palsy. It would provide a direct cause and effect relationship between equinus and bone deformity. Mechanical insights to the pathophysiology of the targeted muscles will lead to better understanding and, thus, to a better medical and surgical management of equinus deformity. Secondary aim will provide an important insight whether key gait parameters can be exclusively relied upon for surgical treatment planning and evaluation. In a medium-term perspective, depending upon the results of this study, dynamic MRI of the ankle joint may serve as a guiding tool for fixed equinus surgery in case of cerebral palsy.
Detailed description
Equinus is the most common deformity in children with cerebral palsy. Spastic equinus is typically defined as the inability to dorsa-flex the foot above plantigrade, with the hindfoot in neutral position and the knee in extended position. Approximately 90% of the deformities in cerebral palsy occur in the ankle and foot region alone with the incidence of equinus being around 75%. Spastic equinus exhibits poor muscle control and muscle weakness around ankle and foot, resulting in bone deformities and gait abnormalities. Non-operative conservative management of equinus is typically undertaken up until 8 years in order to prevent recurrent equinus or overcorrection by avoiding high-growth phase of child's development for surgical intervention. Despite these precautions, long term follow-up studies report up to 48% of recurrence rate post-surgery. Recurrence surgery not only increases the economic burden on the society but also has a debilitating impact on children and their families. Previous research is focused on extrinsic risk factors such as CP type, demographic parameters, and clinical gait parameters for surgical recurrence and none assessed the dynamic impact of intrinsic bone deformity on ankle joint and muscle mechanics. A primary reason for this recurrence could be a lack of understanding of bone deformity that might be forcing the child to adapt altered ankle joint and muscle mechanics (bone kinematics, cartilage contact parameters, muscle strain) during dynamic activities. In fact, the surgical treatment of fixed equinus does not consider any bone corrections and focus on muscle release or lengthening only. Being a dynamic pathology, it is critical to understand the in vivo effect of weak ankle joint musculature on joint mechanics and the resultant bone deformity. However, no such efforts have been made so far in the literature. With the advent of technology, researchers have developed and validated dynamic magnetic resonance imaging techniques to analyze in vivo muscle and joint mechanics. Processing this data enables researchers to analytically track bones without having to identify specific points or anatomical landmarks and thus provides the ability to track muscle motion as well as skeletal motion. Thus properties such as bone kinematics, cartilage contact mechanics, musculotendon moment arms, muscle strain and tendon strain are available from these analyses. These techniques can be successfully employed in equinus research to evaluate ankle joint and muscle mechanics in vivo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Equinus cohort | Experimental | Radiation: MRI scanner, Other: Gait analysis15 childrens who have a fixed equinus defined as a fixed limitation of dorsiflexion inferior to 0°. Interventions: MRI scanner and gait analysis |
| Control cohort | Experimental | Radiation: MRI scanner, Other: Gait analysisIn this cohort, there will be 15 childrens with age and gender matched to equinus cohort and with no history of lower limb musculo-skeletal injury in past 6 months. Interventions: MRI scanner and gait analysis |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| MRI scannerAlso: MRI data on pediatric ankle jointThis examination is divided in 2 parts: * Passive movement: after placing the ankle joint in the fixture, each child will be asked to relax the lower limb musculature and then the fixture will be cyclically moved by a technician at a speed which does not trigger spasticity. * Active movement: no technician will be present and children will be asked to perform voluntary plantar-dorsiflexion between the extreme positions on the beat of the metronome. | Radiation | Control cohort, Equinus cohort |
| Gait analysisAlso: Gait evaluationFor gait evaluation, each child will undergo a lower limb gait analysis in a motion analysis laboratory equipped with Camera system and 4 AMTI force plates Sixteen reflective markers will be placed on the lower limbs. Each child will walk bare foot and gait will be recorded during each of five 10-meter trials. A velocity of 1 m/s (+/- 10%) will be imposed using a stop watch in order to eliminate the influence of velocity on gait kinematics and kinematics while comparing across subjects. Each child will be allowed to walk for 5 minutes after attaching the reflective markers and before recording the gait data. In addition to the joint kinematics, joint powers and moments will be computed using an inverse dynamics method. | Other | Control cohort, Equinus cohort |
Primary outcome
Talocrural joint flexion, pronation, and internal rotations
Time frame: One year
Talocrural (talus relative to tibia) joint rotations and translations will be compared between two cohorts.
Subtalar joint flexion, pronation, and internal rotations
Time frame: one year
Subtalar (calcaneus relative to talus) joint rotations and translations will be compared between two cohorts.
Achilles tendon moment arm (MAAT)
Time frame: one year
MAAT is defined as a perpendicular 3D distance between Achilles' tendon line of action and the Medial-lateral Calcaneal axis. Using calcaneal kinematics, MAAT value for each time frame will be quantified and compared between two cohorts.
7 secondary outcomes
Ankle joint kinematics (joint angles) during walking
Time frame: one year
Knee joint kinematics (joint angles) during walking
Time frame: one year
Hip joint kinematics (joint angles) during walking
Time frame: one year
Talocrural joint contact area
Time frame: one year
Talocrural joint contact centroid location
Time frame: one year
Subtalar joint contact area
Time frame: one year
Subtalar joint contact centroid location
Time frame: one year
Results and safety
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Results publication: PubMed 31946318Makki K, Borotikar B, Garetier M, Acosta O, Brochard S, Ben Salem D, Rousseau F. 4D in vivo quantification of ankle joint space width using dynamic MRI. Annu Int Conf IEEE Eng Med Biol Soc. 2019 Jul;2019:2115-2118. doi: 10.1109/EMBC.2019.8856687.
- Results publicationCheng, Y., Bailly, R., Borotikar, B., Scavinner-Dorval, C., Fouquet, B., Salem, D. B., ... & Rousseau, F. (2023, April). Morphological analysis of ankle shorts bones of children with cerebral palsy: a comparative study. In Medical Imaging 2023: Image Processing (Vol. 12464, pp. 584-588). SPIE.
- Results publicationScavinner-Dorval, C., Bailly, R., Borotikar, B., Brochard, S., Salem, D. B., & Rousseau, F. (2024, April). Analysis of disentangled representation learning for high-resolution dynamic MRI synthesis. In Medical Imaging 2024: Image Processing (Vol. 12926, pp. 694-699). SPIE
- Individual participant dataSharing planned: No
Related trials for Equinus Deformity
Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Not yet recruiting
The Corrective Power of Subtalar Arthrodesis With Mini/Medial Bone Block (SAMBB) in Patients Affected by Progressive Collapsing Foot Deformity (PCFD): Analysis Using Weight-bearing Cone Beam CT.
Flat Foot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
Flexible Flatfoot
Recruiting
Plantar Stimulation, Whole-Body Vibration, and Baduanjin for Muscle Activation
Flat Feet, Lower-Limb Muscle Activation
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?
A study testing MRI scanner and Gait analysis in people with Equinus Deformity, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 3 Apr 2025. 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 France. 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 was stopped early (reason given: lack of inclusion). Results are not available in the source record.
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?
Talocrural joint flexion, pronation, and internal rotations (time frame: One year). The study lists 3 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 NCT02814786, which also lists 3 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 3 Apr 2025.