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临床试验/NCT04529642
NCT04529642已完成不适用

Is the 6-Minute Walking Test Combined With an IMU Useful in Stroke Rehabilitation Assessment? A Pilot Observational Study

Fondazione Don Carlo Gnocchi Onlus1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2019年2月1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
46
试验地点
1
主要终点
Motricity Index

研究概览

简要总结

This Observational study aims at the evaluation of stroke subjects with an inertial measurement unit (IMU) during the execution of a 6-Minute Walking test, to evaluate the associations between the kinematic parameters retrieved trough an IMU and the classical outcome scales. Moreover compare the stroke subjects with age-matched healthy subjects, and detect the differences of gait kinematic.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >= 18;
  • Mini-Mental State Examination ≥ 24;
  • Ability to provide written informed consent and to understand the test instructions;
  • Presence of a single stroke.

排除标准

  • More than one stroke;
  • . Stroke area other than the cerebral cortex;
  • Concomitant neurological disease and pathology of the locomotor system.
  • Healthy Group
  • Inclusion Criteria:
  • Volunteers with age similar to the Stroke group subjects
  • Exclusion Criteria:
  • Any disease that could affect the performance in terms of metres walked and quality of gait.

结局指标

主要结局

Motricity Index

时间窗: Baseline

To assess the strength of stroke subjects

Gait speed

时间窗: 1 day

Assessed through an Inertial Measurement Unit, in different moments of the 6-Minute walking test.

Step Cadence

时间窗: 1 day

Amount of steps for each minute

Meters walked

时间窗: 1 day

The amount of meters walked in 6 minutes

Symmetry

时间窗: 1 day

AN index of the symmetry between the two sides of the subjects during gait

Temporal parameters of gait

时间窗: 1 day

Assessed through an Inertial Measurement Unit, it include the time length of steps, of the stance phase, of double and single limb support phase.

Canadian Neurological Stroke Scale

时间窗: Baseline

To state the stroke condition

Berg Balance Scale

时间窗: Baseline

To assess the balance of stroke subjects

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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