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临床试验/NCT05510726
NCT05510726已完成不适用

Reliability, Validity, and Responsiveness of Shearwave Elastography to Assess Muscle Stiffness in Neurological Population With Muscle Overacivity

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
reliability, validity and responsiveness shearwave elastography (SWE) to assess muscle elasticity

研究概览

简要总结

Objective:

  1. to investigate reliability, validity and responsiveness of shearwave elastography (SWE) to assess muscle stiffness of overactive upper or lower limb muscles in different angle joint positions in patients with neurological condition
  2. to investigate the relationship between muscle stiffness measured by SWE and by MyotonPro
  3. to investigate the correlation between muscle stiffness measured by SWE and clinical outcomes

Methods: each patient will be assessed three times: two times at an interval of 15 minutes on the same day and one time at an interval of one week at the same time of the day. The following measurements will be made at each evaluation: SWE, MyotonPro, clinical evaluation. SWE and MytotonPro will be taken at different angle joint position.

Outcomes: muscle stiffness measured by SWE and MyotonPro at different angle joint positions, and clinical evaluation (passive range of motion, modified ashworth scale, tardieu scale, fuglmeyer) Hypothesis: SWE is a valid, reliable, and resposive method to assess muscle stiffness in neurological population with muscle overactivity. The results of SWE will be correlated with the results of MyotonPro and with clinical outcomes.

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
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 years
  • hemiparesia/-plegia following neurological condition (TBI, stroke,...)
  • > 3 months after injury
  • muscle overactivity in lower limb

排除标准

  • other neurological or orthopaedic conditions involving the affected limb
  • aphasia or major cognitive impairment limiting functional assessment
  • botulinum toxin injection in the last 3 months
  • previous treatment of muscle overactivity with surgical procedures.

结局指标

主要结局

reliability, validity and responsiveness shearwave elastography (SWE) to assess muscle elasticity

时间窗: Day 1 + 7-14 days

expressed in m/s. A smaller shearwave velocity indicates a better outcome

次要结局

  • muscle stiffness assessment with MyotonPro(two times day 1 at 15minutes interval + 7-14 days later at same time of the day)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (1)

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