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临床试验/NCT05487287
NCT05487287Unknown不适用

Computational Assessment of Hand Motor Skills in Stroke Patients

Instituto de Investigación Hospital Universitario La Paz1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年5月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Relation between hand kinematic computational analysis and stroke lesion on brain MRI.

研究概览

简要总结

This is a two phase prospective observational study that aims to validate the use of a motion capture software (Leap Motion) to measure and quantify functional deficits of the hand in stroke patients using a standard battery of exercises. The objectives of this study are:

  1. To compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects.
  2. To analyze the relation between hand kinematic computational analysis and clinical scales usually performed to evalutate neurologic deficits in stroke patients.
  3. To analyze the relation between hand kinematic computational analysis and stroke lesion on brain MRI.
  4. To analyze changes between results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Stroke patients: clinically stable, with hand functional deficit at the momment they consent to participate in the study. Signed consent to participate.
  • Healthy subjects: similar age to stroke patients, without previous clinical history of stroke or any disease that could affect hand motor skills. Signed consent to participate.

排除标准

  • Aphasia or cognitive impairment, confusional syndrome or other conditions that could prevent comprehension and acomplishment of the task.
  • Plegia or severe paresis of the hand that could prevent adecuate performance of the task.
  • Previous stroke.
  • Previous dependance.
  • Previous diagnosis of any other neurologic disease or condition that could affect hand motricity.
  • Life expectancy below three months.

结局指标

主要结局

Relation between hand kinematic computational analysis and stroke lesion on brain MRI.

时间窗: First month

To analyze the relation between hand kinematic computational analysis and stroke lesion on brain MRI.

Relation between hand kinematic computational analysis and clinical scales

时间窗: First month

To analyze the relation between hand kinematic computational analysis and clinical scales usually performed to evalutate neurologic deficits in stroke patients.

Hand kinematic computational analysis

时间窗: First month

o compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects.

Results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life.

时间窗: 1 month and three months

Changes between results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life.

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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