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临床试验/NCT06497881
NCT06497881招募中不适用

Monitoring Post Stroke Upper-Limb Movement in The Wild

Adi Negev-Nahalat Eran1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Active joint range

研究概览

简要总结

The aim of this study is to monitor the daily upper limb movement of persons with stroke, and to relate these quantities to measures of recovery and impairment.

详细描述

This study is part of The Natural History of Stroke Recovery project. In this study the investigators plan to develop, test and validate an algorithm and software for using Inertial Measuring Units (IMUs) to monitor upper limb daily movement. Then, investigators plan to use this system to monitor such activity in stroke patients.

Investigators also plan to develop, test and validate an algorithm and software to test proprioception acuity based on muscle synergy during active and passive movement. Muscle synergy will be determined based on muscles' electrical activity, as measured using surface electromyography (EMG).

Investigators will then test the relation between daily movements of the upper limb in stroke patients, and their recovery/impairment levels, including proprioception acuity.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >18 years of age
  • Independent in all activities of daily living before the stroke.
  • In- and out-patients at Adi-Negev Nahalat-Eran rehabilitation center.
  • Medically stable
  • Able to provide informed consent.

排除标准

  • The presence of any degenerative neurological condition, neuropathy, myopathy or Polio that are not secondary to stroke, excluding diabetic related changes.
  • Traumatic brain injury and/or extra-cerebral hemorrhage.
  • Significant psychiatric condition, including alcoholism and drug abuse.
  • Any severe orthopedic condition (such as amputation or severe pain that limits activity) or chronic pain syndrome.

结局指标

主要结局

Active joint range

时间窗: One or two occasions over 1-6 hours each.

Maximum, minimum, and mean range of motion of the joints during daily activity. Measured in degrees/radians.

Hand movements-count

时间窗: One or two occasions over 1-6 hours each.

The number of hand movements (count)

Hand movements-duration

时间窗: One or two occasions over 1-6 hours each.

The total and average (per hour) time the hands moved, over the tested period. Measured in minutes.

Wrist distance

时间窗: One or two occasions over 1-6 hours each.

The maximum, average and total distance of the wrist from the body during movements. Measured in cm.

次要结局

  • Proprioception-1(One occasions during the first month following recruitment.)
  • Angular velocity.(One or two occasions over 1-6 hours each.)
  • Action Research Arm Test (ARAT)(One occasions during the first month following recruitment.)
  • Joint range of motion(One or two occasions over 1-6 hours each.)
  • Synergies(One or two occasions over 1-6 hours each.)
  • Whole body movement time(One or two occasions over 1-6 hours each.)
  • Proprioception-2(One occasions during the first month following recruitment.)
  • Fugl-Meyer Assessment (FMA)(One occasions during the first month following recruitment.)
  • Proprioception-3(One occasions during the first month following recruitment.)
  • Movement volume(One or two occasions over 1-6 hours each.)

研究者

发起方
Adi Negev-Nahalat Eran
申办方类型
Other
责任方
Sponsor

研究点 (1)

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