跳至主要内容
临床试验/NCT06624280
NCT06624280已完成不适用

Does Orthopedic Surgery Improve Gait Efficiency in Children With Cerebral Palsy? A Retrospective Study

Azienda Unità Sanitaria Locale Reggio Emilia2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年2月20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
78
试验地点
2
主要终点
Mean maximum knee extension in the gait cycle

研究概览

简要总结

Purpose: The aim of this retrospective observational study is to describe the demographic, clinical, and functional characteristics of children and adolescents with spastic cerebral palsy (CP) undergoing Single Event Multilevel Surgery (SEMLS) and changes in their gait efficiency following surgery.

Methods: Seventy-eight participants were included and a total of eighty-four SEMLS analyzed. All the participants were followed by the Children Rehabilitation Unit of the Local Health Authority of Reggio Emilia. Participants met the following requirements: age 4-20 years; hemiplegic or diplegic CP; Gross Motor Function Classification System level I, II or III; 3D gait analysis either before and after surgery. The following parameters were reported: maximum hip and knee extension in the gait cycle, to measure the gait efficiency; normalized maximum power produced by the ankle during push-off phase, to express the propulsive capacity; normalized speed and normalized stride length as global gait performance measure.

详细描述

Children with Cerebral Palsy (CP) often have gait difficulties due to poor motor control, spasticity, skeletal deformities, and muscle weakness. Their walking is usually slow, tiring, with reduced endurance, and a higher risk of falls. As a result, these children often have limited participation in daily activities and a lower quality of life. Among the most common treatments, functional orthopedic surgery is now considered the "standard of care" for these patients. Many studies have shown that surgery has a positive impact on walking ability.

In the traditional surgical approach, patients undergo multiple operations, each correcting a single issue. For example, fixing a shortened triceps muscle, to allow the foot to fully contact the ground, might be followed by lengthening the knee flexors to enable full knee extension and upright standing. This step-by-step process, where surgeries are often done annually, was called the "birthday syndrome". Some researchers have studied the effects of surgery on specific walking issues. For example, in 2022, Kruger K.R. et al. examined the long-term impact of correcting valgus-pronated feet. Dohin B. et al., in 2020, looked at how lengthening knee flexors and adductors improved in-toeing gait. Krupiński M. et al., in 2015, studied the effect of Achilles tendon lengthening in children with toe-walking (equinus gait). While these studies provided useful insights for clinicians, they often oversimplified the complexity of the underlying problems.

In CP, multiple areas of the body are usually involved in walking difficulties, as seen in crouch gait (walking with bent knees), which can have many causes that influence each other. This often requires surgery on multiple areas at once to improve the overall balance of the body. More recently, surgeons have adopted a technique where multiple deformities are corrected in a single surgery, often involving both lower limbs. This approach, known as single-event multilevel surgery (SEMLS), reduces the number of surgeries compared to the traditional method of addressing one issue at a time. However, as children grow, additional SEMLS procedures may be needed to address new issues that arise, such as muscle tightness. Several studies have shown that these multilevel surgeries can improve walking ability. Saglam Y. et al., in 2016, studied the combination of femoral derotational osteotomy and soft tissue procedures in children with in-toeing gait. In 2022, Pierz K. et al. examined how SEMLS, including knee flexor lengthening combined with other techniques (such as triceps lengthening or tibial derotational osteotomy), improved walking in children with crouch gait. Moreira de Freitas Guardini K. et al., in 2021, also studied a large sample of children undergoing SEMLS, focusing on their clinical characteristics.

Evaluating the effects of surgery requires selecting appropriate outcome measures, which is not always simple. Most studies aim to improve "gait quality" but do not always confirm if the chosen parameters lead to real functional improvements for the patient. Some researchers use measures from physical exams (e.g., range of motion, muscle strength) or biomechanical data from gait analysis (3DGA, the gold standard for assessing gait in children with CP). These studies often focus on how the body moves (kinematics) and on spatiotemporal parameters such as walking speed and step length, along with summary indices. These parameters show changes in the specific area operated on and how the body moves as a whole. They provide information on alignment and symmetry of the legs during movement.

However, a well-aligned structure does not necessarily involve that the system works efficiently, meaning it minimizes energy expenditure during walking. Gait efficiency is especially important in children with CP, as many studies have shown that inefficient gait leads to increased energy consumption and mechanical work. Therefore, it is important to consider not only joint movement and overall performance but also other aspects, since kinematic data and physical exams do not provide information on gait efficiency.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
4 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of diplegic or hemiplegic CP;
  • GMFCS levels I, II, or III;
  • aged between 4 and 20 years;
  • Lower limb Single Event Multilevel Surgery (SEMLS)
  • 3D gait analysis before and after surgery

排除标准

  • more than one lower limb surgery event between the two gait assessments
  • one single gait evaluation

结局指标

主要结局

Mean maximum knee extension in the gait cycle

时间窗: T0 (before SEML) and T1 (8-38 months after SEMLS)

It is an indirect measure of walking efficiency. Greater knee extension leads to lower energy consumption. The measurement is calculated using 3D Gait Analysis. It has already been used to assess gait efficiency in children with CP (Noorkoiv, 2019), but never to evaluate the effects of surgery. These measures are useful when dynamic data are not available, such as when the stride length is short or the patient has low endurance, making it difficult to collect such data

change from baseline in maximum knee extension

时间窗: T0 (before SEML) and T1 (8-38 months after SEMLS)

It is an indirect measure of walking efficiency. Greater knee extension leads to lower energy consumption. The measurement is calculated using 3D Gait Analysis. It has already been used to assess gait efficiency in children with CP (Noorkoiv, 2019), but never to evaluate the effects of surgery. These measures are useful when dynamic data are not available, such as when the stride length is short or the patient has low endurance, making it difficult to collect such data.

次要结局

  • Correlation between the effect of surgery and the level of impairment(at T1( 8-38 months after SEMLS ))
  • Correlation between the effect of surgery and the age of participants(at T1( 8-38 months after SEMLS ))
  • change from baseline in maximum hip extension(T0 (before SEML) and T1 (8-38 months after SEMLS))
  • change from baseline in power produced by the ankle during push-off phase(at T1( 8-38 months after SEMLS ))
  • change from baseline in energy produced and absorbed(T0 (before SEML) and T1 (8-38 months after SEMLS))
  • Change from baseline in Biomechanical Efficiency Quotient (BEQ)(T0 (before SEML) and T1 (8-38 months after SEMLS))
  • Change from baseline in Gait Profile Score (GPS)(T0 (before SEML) and T1 (8-38 months after SEMLS))
  • Change from baseline in speed, Stride length, ratio frequency/stride lenght, stance time and double support(T0 (before SEML) and T1 (8-38 months after SEMLS))

研究者

发起方
Azienda Unità Sanitaria Locale Reggio Emilia
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Silvia Faccioli

Principal Investigator

Azienda Unità Sanitaria Locale Reggio Emilia

研究点 (2)

Loading locations...

相似试验