Clinical trial NCT02814786: Dynamic Evaluation of Ankle Joint and Muscle Mechanics in Children With Spastic Equinus Deformity Due to Cerebral Palsy
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Equinus Deformity
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 24
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Talocrural joint flexion, pronation, and internal rotations
timeFrame: One year
measure: Subtalar joint flexion, pronation, and internal rotations
timeFrame: one year
measure: Achilles tendon moment arm (MAAT)
timeFrame: one year
Secondary outcomes:
measure: Ankle joint kinematics (joint angles) during walking
timeFrame: one year
measure: Knee joint kinematics (joint angles) during walking
timeFrame: one year
measure: Hip joint kinematics (joint angles) during walking
timeFrame: one year
measure: Talocrural joint contact area
timeFrame: one year
measure: Talocrural joint contact centroid location
timeFrame: one year
measure: Subtalar joint contact area
timeFrame: one year
measure: Subtalar joint contact centroid location
timeFrame: one year
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
References:
citation: 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.
citation: 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.
citation: 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