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临床试验/NCT04879199
NCT04879199已完成不适用

Stop Tip-toeing Around Toe-walking: Towards a Better Understanding and More Effective Treatment of Toe-walkers With Cerebral Palsy

University Children's Hospital Basel2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年8月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Static stability assessed by Center of Pressure (COP) shifts in anterior-posterior and mediolateral directions under each limb

研究概览

简要总结

The purpose of this study is to explore the interplay among nervous-, musculoskeletal-, and psychological systems and how they impact toe-walking behavior, and vice versa.

Sub-Project 1 is to analyze the feasibility of the developed virtual reality (VR) environment, in 10 TD and sCP children respectively. It is assess the effects of VR immersion on predefined static and dynamic stability parameters.

Sub-Project 2: After adjustments have been made following Sub-Project 1 regarding the study procedure, technical factors or the parameters of interest etc., the optimized study procedure is implemented in Sub-Project 2 (20 to 25 TD will be included).

Sub-Project 3: After adjustments have been made following Sub-Project 1 regarding the study procedure, technical factors or the parameters of interest etc., the optimized study procedure is implemented in Sub-Project3 (20 to 25 sCP will be included)

详细描述

The interplay between the nervous-, musculoskeletal-, and psychological systems and their impact on resulting walking patterns are poorly understood. Children that toe-walk often show poorer levels of static and dynamic stability, leading to a lower quality of life compared to typically develop-ing children (TD). Current research suggests multifactorial adaptations in central and/or peripheral nervous as well as the musculoskeletal system contribute to and result from toe-walk-ing. The purpose of this study is to explore the interplay among nervous-, musculoskeletal-, and psychological systems and how they impact toe-walking behavior, and vice versa. The effect of psychological factors (via the use of a custom-designed virtual reality environment) on static vs. dynamic stability, motor control, coordination (indirect assessment of central nervous system function) as well as reflex control (Hoffmann-reflex, H-reflex, performance of peripheral nervous system) is investigated.

研究设计

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

入排标准

年龄范围
7 Years 至 18 Years(Child, Adult)
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

Static stability assessed by Center of Pressure (COP) shifts in anterior-posterior and mediolateral directions under each limb

时间窗: one time assessment at baseline (complete baseline assessments up to 3 hours)

COP shifts in anterior-posterior and mediolateral directions under each limb are assessed via the use of two force plates embedded in the floor (Kistler Instrumente AG, Winterthur, Switzerland, sample rate 1500 Hz) (mean value of three repetitions)

Dynamic stability assessed by number of muscle synergies

时间窗: one time assessment at baseline (complete baseline assessments up to 3 hours)

Number of muscle synergies assessed via the use of a sixteen-channel surface electromyography system

Static stability assessed by Visual Analogue Scale (VAS)

时间窗: one time assessment at baseline (complete baseline assessments up to 3 hours)

Self-perceived degree of safety during walking in the VR environment will be assessed using a Visual Analogue Scale (VAS) ranging from 0 ("feeling completely safe") to 10 ("feeling completely unsafe")

Static stability assessed by Ratio between H-reflex and M-wave amplitude

时间窗: one time assessment at baseline (complete baseline assessments up to 3 hours)

Ratio between H-reflex and M-wave amplitude, measured through soleus muscle in affected side of hemiplegic sCP and in none-dominant side for diplegic CP and TD (recruitment curve of the H-reflex and the M-wave of the Soleus elicited by stimulating the tibial nerve while standing)

Dynamic stability assessed by COP shifts in combination with base of support trajectory

时间窗: one time assessment at baseline (complete baseline assessments up to 3 hours)

COP shifts in combination with base of support trajectory assessed via the use of four force plates embedded in the floor (mean value of three repetitions)

Dynamic stability assessed by interlimb coordination

时间窗: one time assessment at baseline (complete baseline assessments up to 3 hours)

Interlimb coordination will be calculated by using kinematic data from lower and upper extremities

Dynamic stability assessed by Self-perceived degree of safety during walking in the VR environment using a Visual Analogue Scale (VAS)

时间窗: one time assessment at baseline (complete baseline assessments up to 3 hours)

Dynamic stability assessed by Self-perceived degree of safety during walking in the VR environment using a Visual Analogue Scale (VAS) ranging from 0 ("feeling completely safe") to 10 ("feeling completely unsafe")

次要结局

  • Dynamic stability measurement assessed by kinematic data of upper & lower extremities (joint angles in degree)(one time assessment at baseline (complete baseline assessments up to 3 hours))
  • Dynamic stability measurement assessed by spatiotemporal parameters: walking speed (normalized to leg length) [m/(s*mm)](one time assessment at baseline (complete baseline assessments up to 3 hours))
  • Dynamic stability measurement assessed by spatiotemporal parameters: cadence [steps/min](one time assessment at baseline (complete baseline assessments up to 3 hours))
  • Dynamic stability measurement assessed by spatiotemporal parameters: step length [m](one time assessment at baseline (complete baseline assessments up to 3 hours))
  • Dynamic stability measurement assessed by spatiotemporal parameters: stride width [s](one time assessment at baseline (complete baseline assessments up to 3 hours))
  • Dynamic stability measurement assessed by spatiotemporal parameters: double support time [s](one time assessment at baseline (complete baseline assessments up to 3 hours))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Stop Tip-toeing Around Toe-walking | 临床试验