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临床试验/NCT04502927
NCT04502927终止不适用

Measurements of Displacement Amplitude and Angular Velocities During Passive Extension of the Wrist and Hand Complex in Stroke Patients

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2020年3月10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
2
试验地点
1
主要终点
Amplitude values

研究概览

简要总结

The main objective of this monocentric prospective study is to evaluate the amplitudes and angular velocities of extension of the hand and wrist joints during passive mobilization by a physiotherapist in healthy subjects and stroke patients with spastic hands.

Secondary objectives:

  • To compare amplitude and angular velocity values between the group of stroke patients and the group of healthy volunteers,
  • To compare amplitude and angular velocity values according to the two types of mobilization (i,e, thumb or fifth finger),
  • To assess pain due to mobilization in stroke patients.

详细描述

Conduct of research:

The realization of the measures will take place at the GHRMSA rehabilitation department.

After receiving the written consent of the study participant, the physiotherapist will proceed with the passive mobilization of the spastic hand of the stroke patient or the dominant hand for healthy volunteers. Videos of the hand will be made using the Darfish system which will allow analysis of the primary endpoint.

Two mobilizations will be performed for each participant, i.e. one for each type of medial or lateral grip. The order of mobilization will be determined by randomization.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years old
  • First stroke diagnosed less than 3 months ago
  • Non-functional wrist defined by the Fugl-Meyer Assesment (FMA-EU) upper limb motor subscale with a score ≤45
  • Wrist flexor spasticity defined by the Modified Tardieu Scale (MTS) with a rating ≥1
  • Written informed consent

排除标准

  • Eligibility criteria of healthy volunteers:
  • Inclusion criteria:
  • Age ≥ 18 years old
  • Written informed consent
  • Exclusion Criteria:

结局指标

主要结局

Amplitude values

时间窗: 1 minute after intervention

Amplitude values will be calculated with the Dartfish® system

Angular velocity values

时间窗: 1 minute after intervention

Angular velocity values will be calculated with the Dartfish® system

次要结局

  • Mean angular velocity after mobilization with thumb abduction(1 minute after intervention)
  • Mean amplitude after mobilization of the fifth finger(1 minute after intervention)
  • Pain experienced by stroke patients after mobilisation(1 minute after intervention)
  • Mean amplitude of the two groups(1 minute after intervention)
  • Mean angular velocity of the two groups(1 minute after intervention)
  • Mean amplitude after mobilization with thumb abduction(1 minute after intervention)
  • Mean angular velocity after mobilization of the fifth finger(1 minute after intervention)
  • Pain experienced by stroke patients before mobilisation(1 minute before intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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