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临床试验/NCT04607486
NCT04607486已完成不适用

Reliability Study of a 3D Free-hand Ultrasonography Technique (3DfUS) in Combination With Instrumented Spasticity Assessment (ISA) for the Lower Limb in Chronic First-ever Stroke Patients.

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2018年6月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
1
主要终点
Muscle and Tendon Length

研究概览

简要总结

The aim of this study is to investigate lower limb muscles after cerebrovascular accident

详细描述

The aim of this study is to define and differentiate the changes in MMT properties related to the alterations in muscle tone of the lower limb in first-ever chronic stroke patients by using a 3D free-hand Ultrasonography (3DfUS) technique in combination with an instrumented spasticity assessment (IPSA). In these chronic stroke patients, the spontaneous neurological recovery is stabilized

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Definition of case population :
  • o first ever stroke with spasticity of the lower limb.
  • Definition of control :
  • first ever stroke without spasticity of the lower limb
  • healthy aged-matched subjects

排除标准

  • Musculoskeletal or neurological problems affecting the lower limb
  • Presence of other neurological pathology that could lead to spasticity, ataxia, dystonia
  • Cognitive problems that impede measurements
  • Severe co-morbidities
  • Peripheral spastic medication

结局指标

主要结局

Muscle and Tendon Length

时间窗: 1 day

Estimation of muscle volume by 3D freehand ultrasonography

Echogenicity intensity

时间窗: 1 day

Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values).

Work [J] derived from the slow stretch

时间窗: 1 day

Measurement of Work \[J\] by Instrumented Spasticity Assessment

Muscle activity EMG [uV] derived from the fast stretch

时间窗: 1 day

Measurement of Muscle activity EMG \[uV\] by Instrumented Spasticity Assessment

Stiffness [Nm/deg] for slow stretch

时间窗: 1 day

Measurement of Stiffness \[Nm/deg\] by Instrumented Spasticity Assessment

Joint angle of catch [deg] from the fast stretch

时间窗: 1 day

Measurement of Joint angle of catch \[deg\] from the fast stretch by Instrumented Spasticity Assessment

Muscle volume

时间窗: 1 day

Estimation of muscle volume by 3D freehand ultrasonography.

Maximal velocity of performance (Vmax [deg/s])

时间窗: 1 day

Measurement of Maximal velocity of performance (Vmax \[deg/s\]) by Instrumented Spasticity Assessment

Angle of EMG threshold [deg] from the fast stretch

时间窗: 1 day

Measurement of Angle of EMG threshold \[deg\] by Instrumented Spasticity Assessment

Intensity of catch derived from the fast stretch

时间窗: 1 day

Measurement of Intensity of catch by Instrumented Spasticity Assessment

Range of motion [deg] for slow stretch

时间窗: 1 day

Measurement of Range of motion \[deg\] by Instrumented Spasticity Assessment

次要结局

  • Clinical assessment of spasticity angle at slow and fast stretch(1 day)
  • Clinical assessment of spasticity at fast stretch(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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