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临床试验/NCT06163950
NCT06163950终止不适用

The Decline in Walking Performance in Adults With Cerebral Palsy - Influence of Performance Fatigability

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月2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
30
试验地点
2
主要终点
Neuromuscular fatigue

研究概览

简要总结

Due to an early brain injury occurring in antenatal or postnatal, cerebral palsy (CP) causes alteration in motor function with posture and gait disorders. It is commonly observed motor performance degradation during adulthood, and the underlying pathophysiology remains poorly known.

详细描述

One of the hypotheses to explain the decline in walking capacities in adults with CP is their greater fatigability, that could be related to energy overconsumption (due to the specific biomechanical constraints of their walking pattern) and/or the occurrence of early sarcopenia affecting the compensatory muscle mechanisms commonly seen in children to compensate for architectural disorders and posture alterations. To optimize prevention and/or therapy in these patients, it is crucial to better understand the aetiology of fatigability and its role in the decline in walking performance.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Common for CP and healthy volunteers:
  • Capable of walking for six minutes without stopping
  • Capable of consenting to the tests
  • Specific for the CP group
  • GMFCS I or II at age 18
  • Spastic diplegic cerebral palsy

排除标准

  • Counter-indications to the test procedures
  • Mental retardation or intelligence quotient (IQ) below 80
  • Accompanying diseases not allowing for the test setup
  • Major surgeries altering performance in the last six months
  • Injection of botulin altering maximal force production in the last three months
  • Refusing to sign the consent form

结局指标

主要结局

Neuromuscular fatigue

时间窗: Week : 6

Neuromuscular fatigue, defined as the decrease in maximal voluntary force (in % of the resting value) developed in isometric knee extension following a standardized fatigue protocol.

次要结局

  • Maximum voluntary force torque measurement of the knee flexor muscles(Week : 2)
  • Maximum voluntary force torque measurement of knee extensor muscles(Week : 4)
  • VO2max (in mL/min/kg)(Week : 6)
  • Measurement of joint amplitude (in °)(Week : 6)
  • Evaluation of neuromuscular fatigue(Week : 6)
  • Level of voluntary activation measurement(Week : 6)
  • Time (in seconds) taken during the 10-meter walk test(Week : 6)
  • Walking Quality evaluation(Week : 6)
  • Maximum voluntary force torque measurement of the plantar flexor(Week : 2)
  • Measurement of passive torque (in Nm)(Week : 6)
  • Time (in s) taken in the "Get Up and Go" test(Week : 6)
  • The distance covered (in m) in the 6-minute walking test(Week : 6)
  • Berg Balance Scale(Week : 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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