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临床试验/NCT04721561
NCT04721561已完成不适用

Robotic Assessment of Upper Limb Passive and Active Sensory Processing in the Chronic Phase After Stroke

KU Leuven1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年12月18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
44
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, the investigators have developed a robotic assessment of sensory processing. During this study, the investigators aim to initially validate this novel assessment. The investigators aim to examine 20 chronic stroke patients and 20 age-matched healthy controls using the robotic assessment on one hand, and a set of existing clinical assessments on the other hand. The investigators hypothesize that stroke patients will have a poorer performance on this novel robotic assessment compared to age-matched healthy controls, and that these findings are similar to what is found with existing clinical assessments.

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.

The investigators recently developed a novel robotic assessment of sensory processing, using the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada). This cross-sectional study was set up to initially validate this novel robotic assessment and to collect pilot data to form the basis for future research. 20 chronic stroke patients and 20 age-matched controls will be recruited and will undergo extensive clinical and robotic assessment of upper limb motor and somatosensory function. The investigators hypothesize stoke patients with sensory processing deficits to have a worse performance on this novel robotic assessment compared to healthy controls and patients without sensory processing deficits. The investigators also hypothesize to see moderate to high correlations between the robotic assessment of sensory processing, and clinical assessments for both somatosensory and motor function.

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

  • 未提供

排除标准

  • 未提供

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

次要结局

  • Kinarm: position matching task(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))
  • Action research arm test(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))
  • Perceptual threshold of touch(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))
  • Tactile functional object recognition(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))
  • Fugl-Meyer upper extremity assessment(Once in the chronic phase (at least 6 months after stroke))
  • Barthel index(Once in the chronic phase (at least 6 months after stroke))
  • Montreal cognitive assessment(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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