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临床试验/NCT04723212
NCT04723212已完成不适用

The Effect of Cognition and Age on Robotic Assessment of Upper Limb Passive and Active Sensory Processing

KU Leuven1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年6月10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
KU Leuven
入组人数
80
试验地点
1
主要终点
Kinarm: sensory processing task

研究概览

简要总结

After a stroke, more than two out of three patients experience problems with upper limb movement and sensation. During the past decade, robotic technology has been increasingly used to asses these problems in a detailed and accurate manner. However, sensory processing, one of the most important sensory functions, has not been assessed using robotic technology yet. Therefore, our group has developed a robotic assessment of sensory processing. This study is set up to obtain detailed information on how healthy controls perform on this task. This information can then help in identifying abnormal performances (i.e. upper limb sensory problems) in stroke patients. We aim to examine 40 healthy younger adults and 40 healthy older adults.

详细描述

Up to 70% of stroke survivors show upper limb impairments consisting of motor and/or somatosensory impairments. These impairments often persist well into the chronic stage, and may lead to significant limitations in activities of daily living and may negatively affect quality of life. It is therefore of utmost importance to accurately assess upper limb impairments. Clinical assessments exist for both motor and somatosensory function, but lack good psychometric properties. Robotic technology show promising potential and is readily available to assess motor function and proprioception. Robotic assessment for sensory processing is currently not yet available, despite being the most relevant somatosensory function. Indeed, sensory processing shows the strongest association with upper limb movement, and only shows incomplete recovery at 6 months after stroke.

Our group has recently developed a novel robotic assessment of sensory processing, using the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada). This cross-sectional study is set up to collect a large amount of data from healthy controls, in order to obtain reference values for future research and to serve as control data for comparison with stroke patients. 40 younger healthy adults and 40 older healthy adults will be recruited and will undergo extensive clinical and robotic assessment of upper limb motor and somatosensory function, as well as cognitive function. This study also allows to investigate possible age-related decline in task performance, as well as investigation of the role of cognition in performance on this novel task.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Aged 18-30 years old; or aged 55+

排除标准

  • History of stroke or TIA
  • Upper limb somatosensory and/or motor impairments
  • Any serious musculoskeletal and/or other neurological conditions
  • Serious communication or cognitive deficits
  • No written informed consent

结局指标

主要结局

Kinarm: sensory processing task

时间窗: Once in the chronic phase (at least 6 months after stroke)

Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing

Kinarm: working memory task

时间窗: Once in the chronic phase (at least 6 months after stroke)

Assessment of working memory on the Kinarm End-Point Lab, by asking the participant to remember the position of 3, 4, 5 or 6 targets simultaneously.

次要结局

  • Montreal cognitive assessment(Once in the chronic phase (at least 6 months after stroke))
  • Kinarm: position matching task(Once in the chronic phase (at least 6 months after stroke))
  • Kinarm: visually guided reaching(Once in the chronic phase (at least 6 months after stroke))
  • Erasmus modified Nottingham sensory assessment(Once in the chronic phase (at least 6 months after stroke))
  • Tactile discrimination test(Once in the chronic phase (at least 6 months after stroke))
  • Tactile functional object recognition(Once in the chronic phase (at least 6 months after stroke))
  • Stereognosis section of the original Nottingham sensory assessment(Once in the chronic phase (at least 6 months after stroke))
  • Wrist position sense test(Once in the chronic phase (at least 6 months after stroke))
  • Perceptual threshold of touch(Once in the chronic phase (at least 6 months after stroke))
  • Fugl-Meyer upper extremity assessment(Once in the chronic phase (at least 6 months after stroke))
  • Action research arm test(Once in the chronic phase (at least 6 months after stroke))
  • Barthel index(Once in the chronic phase (at least 6 months after stroke))
  • Star cancellation test(Once in the chronic phase (at least 6 months after stroke))

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof Geert Verheyden

Prof. Dr.

KU Leuven

研究点 (1)

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