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临床试验/NCT04837365
NCT04837365已完成不适用

Impact of Neuropsychological Disorders on Visual Exploration, Walking Initiation and Walking in Multiple Sclerosis

Lille Catholic University3 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年5月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
3
主要终点
Cadence of walking (in cycles.min-1)

研究概览

简要总结

The study involves MS patients with and without neuropsychological disorders.

The patient will benefit from:

  • A routine neuropsychological assessment, including a cognitive and emotional assessment
  • A clinical examination
  • A three-dimensional analysis of movement

研究设计

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

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Understanding and able to speak French
  • Carriers of MS with relapsing remitting form (RRMS-RR) with an EDSS <4
  • No significant motor, cerebellar or somesthesia disorders of the upper limbs or visual disturbances (side to a visual EDSS <2)
  • Absence of corticosteroid intake in the last four weeks
  • Benefiting from health insurance coverage
  • Not showing any flare-ups or worsening of the disease in the last 6 weeks
  • No botulinum toxin injection for more than 4 months

排除标准

  • People with previous neurological pathologies, head trauma with loss of consciousness, psychiatric pathologies, serious general ailments, perceptual or dysarthric disorders preventing verbal communication or reading,
  • Treatment with psychotropic drugs (except benzodiazepines and hypnotics).
  • Refusal to participate after clear and fair information about the study.
  • Adults under tutorship, curatorship or safeguard of justice
  • With orthopedic treatment influencing walking
  • Pregnant woman

研究组 & 干预措施

patients without neuropsychological disorders

Other

干预措施: Three dimensional gait analysis with eyetracking (Other)

patients with neuropsychological disorders

Other

干预措施: Three dimensional gait analysis with eyetracking (Other)

结局指标

主要结局

Cadence of walking (in cycles.min-1)

时间窗: 60 days

The kinematics of the initiation of walking and walking will be appreciated thanks to the variables calculated at the level of the joints of the lower limbs as well as the spatio-temporal parameters without and with management of obstacles (taking a step, balloon)

Range of motion in the lower limbs in degrees

时间窗: 60 days

The kinematics of the initiation of walking and walking will be appreciated thanks to the variables calculated at the level of the joints of the lower limbs as well as the spatio-temporal parameters without and with management of obstacles (taking a step, balloon)

Step length (in m)

时间窗: 60 days

The kinematics of the initiation of walking and walking will be appreciated thanks to the variables calculated at the level of the joints of the lower limbs as well as the spatio-temporal parameters without and with management of obstacles (taking a step, balloon)

Walking speed (in m.s-1)

时间窗: 60 days

The kinematics of the initiation of walking and walking will be appreciated thanks to the variables calculated at the level of the joints of the lower limbs as well as the spatio-temporal parameters without and with management of obstacles (taking a step, balloon)

次要结局

  • Ocular fixation time (measured in ms)(60 days)
  • Displacements (in mm) during walking(60 days)
  • Muscle contractions determined by the electromyogram (EMG) (mV)(60 days)
  • Acceleration (in mm.s-2) during walking(60 days)
  • Joint angles(60 days)

研究者

发起方
Lille Catholic University
申办方类型
Other
责任方
Sponsor

研究点 (3)

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