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临床试验/NCT04129749
NCT04129749撤回不适用

Influence of Fatigue on the Walking Pattern in Cerebral Palsy Patients.

Fondation Lenval1 个研究点 分布在 1 个国家开始时间: 2019年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Measure of energy cost during walk in cerebral palsy patients, by evolution of articular force

研究概览

简要总结

To date, studies do not study the influence of external disturbing factors on the market.

The main hypothesis is that the stopping of walking in paralyzed cerebral patients is mainly due to an increase in the energy cost of walking.

The secondary objectives are to study the causes of the increase in the energy cost of walking (modification of muscle coordination / increase of co-activations, loss of strength, etc.).

This study will use the GRAIL combining an instrumented treadmill, a motion capture system (Vicon System), an electromyographic system as well as a virtual environment projected on a 180 ° screen

详细描述

In most studies, the study of the gait of cerebral palsy patients is done through quantified walking analysis tests, objectively evaluating the kinetic and kinematic parameters, associated with the measurement of respiratory exchanges and heart rate.

Nevertheless this very objective evaluation does not really reflect the child's ability to perform the acts of everyday life that he wishes, and in particular, his ability to walk a long time.

It therefore appears that patients do not only want to walk better on an objective and analytical level but also aim to walk longer and improve their walking efficiency.

To date, studies do not study the influence of external disturbing factors on the market.

The main hypothesis is that the stopping of walking in paralyzed cerebral patients is mainly due to an increase in the energy cost of walking.

研究设计

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

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

  • children aged 7 to 18 years (diplegic, hemiparetic or tetraparetic) requiring treatment with botulinum toxin
  • followed at the Lenval Foundation
  • walking alone more than 6 minutes
  • parental information and no disagreement

排除标准

  • Modification of spasticity treatments within 6 months of evaluation: baclofen pump, oral baclofen, retraction surgery (tenotomy, tendon lengthening, arthrodesis ...)
  • dyskinesia
  • Cognitive disorders in children that do not allow the use of GRAIL
  • Contraindication to Botulinum Toxin (myasthenia, hypersensitivity and infections)
  • Contraindication to physical activity (intercurrent pathology)

结局指标

主要结局

Measure of energy cost during walk in cerebral palsy patients, by evolution of articular force

时间窗: at baseline Day 0

Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle. Also evaluated by the evolution of articular force (N/kg) during a 6 minutes walking test.

Measure of energy cost during walk in cerebral palsy patients by evolution of articular power

时间窗: at baseline Day 0

Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle. Also evaluated by the evolution of articular power (W/kg) during a 6 minutes walking test

Measure of energy cost during walk in cerebral palsy patients, by evolution of inter-segmental angle

时间窗: at baseline Day 0

Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle. This will be evaluated by the evolution of inter-segmental angles (degrees) during a 6 minutes walking test.

Measure of energy cost during walk in cerebral palsy patients by evolution of articular moment

时间窗: at baseline Day 0

Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle. Also evaluated by the evolution of articular moment (N.m/kg) during a 6 minutes walking test.

次要结局

  • quantification of biomechanical factors during walking by evolution of articular force(at baseline Day 0)
  • measure of physiological factors during walking by evolution of oxygen consummation(at baseline Day 0)
  • quantification of biomechanical factors during walking by evolution of inter-segmental angles(at baseline Day 0)
  • quantification of biomechanical factors during walking by evolution of articular moment(at baseline Day 0)
  • quantification of biomechanical factors during walking by evolution of of articular power(at baseline Day 0)
  • measure of physiological factors during walking by evolution of carbon dioxide consummation(at baseline Day 0)

研究者

发起方
Fondation Lenval
申办方类型
Other
责任方
Sponsor

研究点 (1)

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