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临床试验/NCT04149301
NCT04149301已完成不适用

Exploration of the Role of Subtalar Joint Morphology in the Development of Foot Deformity in Cerebral Palsy

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
1
主要终点
External loading on the subtalar joint (Measured as a moment in units of Nm)

研究概览

简要总结

Cerebral palsy (CP) is a major cause of disability. Many children with CP develop foot deformities as they grow and these can become painful, adversely affecting their quality of life. The research team has previously studied foot morphology and biomechanics, including analysis of the subtalar joint and has successfully located the joint axis from MRI scans.

In this project 25 children will be recruited (15 children with CP and 10 unimpaired control subjects). Each child will attend for a single visit, when they will undergo an MRI scan (with the foot loaded and unloaded) to measure the morphology of the ankle and foot, in particular the subtalar axis alignment. This has not been done before in CP.

Each child will have an instrumented gait analysis and musculoskeletal modelling techniques will be used to study the biomechanical action of the external ground reaction force and internal muscle forces. The potential of these forces to rotate the subtalar joint and deform the foot will be assessed, resulting in new insights into potential mechanisms of foot deformity.

The children will then be categorised to identify those most at risk, leading to personalised screening measures and treatment strategies in the future.

详细描述

Cerebral palsy (CP) is a common cause of childhood disability with an incidence of 2.11 per 1000 live births. Children with CP often develop problems with their feet during growth, with a reported prevalence of foot deformity of 86% in a group of 66 diplegic children. Deformities may occur in the ankle joint, subtalar joint (the joint below the ankle) and/or the foot itself. The European SPARCLE study reported that 54% of children with CP experienced pain in the previous week, which was associated with a poorer quality of life. This rose to 75% in a subsequent study of adolescents. The most common place for children to experience pain is in the feet, especially for the more mobile children.

Clinical experience is that deformed feet are challenging to manage with splints. Biomechanical changes in the ankle and foot affect the whole leg and a sudden deterioration in gait often follows, for example the development of a crouch gait pattern.

Several mechanisms are proposed for the development of foot deformity, including calf muscle tightness, muscle imbalance, bony subluxation and collapse of the longitudinal arch. It is difficult to separate cause and effect as phenomena occur concurrently.

Previously the research team have examined the morphology of the foot in detail using imaging techniques and gait analysis. To date no one has conducted similar studies looking at the subtalar joint in cerebral palsy and the orientation of the axis in this condition is currently unknown.

Participants in this research (typically developing children and children with cerebral palsy) will only need to attend on a single occasion. They will spend around half a day in the hospital, with measurements being taken in two departments:-

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Able to walk independently (for CP children GMFCS level 1 or 2)
  • Able to understand and comply with experimental protocols

排除标准

  • Any contraindications to MRI scanning eg pronounced startle reflexes or metal implants.
  • Any orthopaedic surgery in the last 6 months, or any previous bony surgery to the ankle of foot.

结局指标

主要结局

External loading on the subtalar joint (Measured as a moment in units of Nm)

时间窗: At baseline

This results from combining the gait analysis data (angles and forces) with the morphology from the MRI scans.

Internal loading on the subtalar joint (Measured as a moment in units of Nm)

时间窗: At baseline

This results from combining the gait analysis data (angles and forces) with the morphology from the MRI scans, through a process of optimisation to distribute internal muscle forces.

次要结局

未报告次要终点

研究者

发起方
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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