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Clinical Trials/NCT02814786
NCT02814786
Terminated
N/A

In Vivo Dynamic Evaluation of Ankle Joint and Muscle Mechanics in Children With Spastic Equinus Deformity Due to Cerebral Palsy: Implications for Recurrent Equinus.

University Hospital, Brest1 site in 1 country24 target enrollmentSeptember 8, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Equinus Deformity
Sponsor
University Hospital, Brest
Enrollment
24
Locations
1
Primary Endpoint
Subtalar joint flexion, pronation, and internal rotations
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 8, 2016
End Date
December 31, 2020
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Talocrural joint contact area(one year)
  • Ankle joint kinematics (joint angles) during walking(one year)
  • Subtalar joint contact centroid location(one year)
  • Hip joint kinematics (joint angles) during walking(one year)
  • Talocrural joint contact centroid location(one year)
  • Subtalar joint contact area(one year)
  • Knee joint kinematics (joint angles) during walking(one year)

Study Sites (1)

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