跳至主要内容
临床试验/NCT02814786
NCT02814786终止不适用

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, Brest2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
24
试验地点
2
主要终点
Subtalar joint flexion, pronation, and internal rotations

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Subtalar joint flexion, pronation, and internal rotations

时间窗: one year

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

Achilles tendon moment arm (MAAT)

时间窗: 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

时间窗: One year

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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