Dynamic Evaluation of Ankle Joint and Muscle Mechanics in Children With Spastic Equinus Deformity Due to Cerebral Palsy

NCT02814786 | Terminated

• 1 other identifier: RB15-159 EQUINUS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Equinus Deformity

Outcome Measures

Primary Outcomes (3)

• Talocrural joint flexion, pronation, and internal rotations

  Talocrural (talus relative to tibia) joint rotations and translations will be compared between two cohorts.

  One year

• Subtalar joint flexion, pronation, and internal rotations

  Subtalar (calcaneus relative to talus) joint rotations and translations will be compared between two cohorts.

  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.

  one year

Secondary Outcomes (7)

• Ankle joint kinematics (joint angles) during walking

  one year

• Knee joint kinematics (joint angles) during walking

  one year

• Hip joint kinematics (joint angles) during walking

  one year

• Talocrural joint contact area

  one year

• Talocrural joint contact centroid location

  one year

Study Arms (2)

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

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

Radiation: MRI scanner; Other: Gait analysis

Interventions

MRI scanner RADIATION

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.

Also known as: MRI data on pediatric ankle joint

Control cohort; Equinus cohort

Gait analysis OTHER

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.

Also known as: Gait evaluation

Control cohort; Equinus cohort

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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°
• 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

You may not qualify if:

• 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.
• Uncooperative patient who refused to sign the informed consent
• Patient unable to understand the protocol, under guardianship
• Patients not affiliated to the Social Security.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU Brest

Brest, 29200, France

Location

Related Publications (3)

• 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.

  PMID: 31946318 BACKGROUND

• Cheng, 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.

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Equinus Deformity

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: June 28, 2016
• Study Start: September 8, 2016
• Primary Completion: April 18, 2019
• Study Completion: December 31, 2020
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)