Evaluating Validity and Reliability of a Novel In-house Developed, Robot-based Sensorimotor Processing Assessment Paradigm for the Upper Limb in the Chronic Phase After Stroke.
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: Passive and active discrimination task
研究概览
简要总结
Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal assessment for sensory processing, one of the most important sensory functions, does not exists. However, our research team has developed a novel assessment paradigm using the KINARM End-Point robot to assess the level of sensory processing of the upper limb. Within a previous study, the investigators examined the validity within 20 chronic stroke patients and 80 age-matched healthy controls by comparing the novel robotic assessment with a set of existing clinical and robotic assessments for the upper limb. The investigators hypothesize that the stroke patients will show a poorer performance on this novel assessment compared to the healthy controls, that the novel assessment will show better correlation coefficients with other sensory tests compared to motor tests, that the novel assessment can differentiate between different motor subgroups of chronic stroke patients, and that the novel assessment shows good test-retest reliability.
详细描述
Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). These impairments may lead to significant limitations in activities of daily living and may negatively affect quality of life. It is therefore of importance to accurately assess upper limb impairments. Clinical assessments exist for both motor and somatosensory function, but lack good psychometric properties. Robotics 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.
Within a previous study of our research team, a novel robotic assessment of sensory processing was developed, using the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada). That 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 80 age-matched controls underwent extensive clinical and robotic assessment of upper limb motor and somatosensory function. For the cross-sectional study, the investigators aim to build further on this previous research. By recruiting 60 additional chronic stroke patients and combining both data of the previous study and this study, the investigators aim to examine the validity and reliability of this novel assessment in a bigger and more heterogeneous group of chronic stroke participants. The investigators hypothesize that stoke patients have a worse performance on this novel robotic assessment compared to healthy controls, that the novel assessment correlates more to standard sensory assessments compared to standard motor assessments, that the novel assessment can differentiate between motor subgroups of chronic stroke patients, and that the novel assessment shows good test-retest reliability.
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
- 否
入选标准
- •Written informed consent must be obtained prior to any screening procedures
- •First-ever unilateral, supra-tentorial stroke (as defined by WHO)
- •At least 18 years old
- •Being in the chronic phase after stroke (i.e. being at least 6 months after stroke)
- •Motor impairment in the upper limb, defined as Fugl-Meyer score >22 out of 66 to demonstrate moderate to full upper limb motor function (patients scoring <23 out of 66 will not be able to comply with the KINARM protocol)
排除标准
- •Any serious musculoskeletal and/or other neurological disorders
- •Severe communication or cognitive deficits that interfere with the protocol
- •Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
结局指标
主要结局
Kinarm: Passive and active discrimination task
时间窗: up to 2 days
Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing
次要结局
- Tactile functional object recognition(1 day)
- Kinarm: Arm position matching task(1 day)
- Kinarm: Visually guided reaching task(1 day)
- Wrist position sense test(1 day)
- Action research arm test(1 day)
- Montreal cognitive assessment(1 day)
- Tactile discrimination test(1 day)
- Erasmus modified Nottingham sensory assessment(1 day)
- Perceptual threshold of touch(1 day)
- Barthel index(1 day)
- Stereognosis section of the original Nottingham sensory assessment(1 day)
- Fugl-Meyer upper extremity assessment(1 day)
- Star cancellation test(1 day)
研究者
Prof Geert Verheyden
Prof. Dr. Geert Verheyden
KU Leuven