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Completed

NCT Number: NCT06382558

Validity and Reliability of Sensorimotor Processing Paradigm

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

KU Leuven

Leuven, 3001, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Kinarm: Passive and active discrimination task

    Time frame: up to 2 days

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

Secondary outcomes

  1. Kinarm: Arm position matching task

    Time frame: 1 day

    Assessment of limb position sense using a 9-target mirror-matching task on the Kinarm End-Point Lab

  2. Kinarm: Visually guided reaching task

    Time frame: 1 day

    Assessment of motor function using a 4-target centre-out reaching task on the Kinarm End-Point Lab

  3. Erasmus modified Nottingham sensory assessment

    Time frame: 1 day

    Clinical assessment of sensory processing with an area under the curve based scoring system, with higher scores meaning better performance

  4. Tactile discrimination test

    Time frame: 1 day

    Clinical assessment of sensory processing with an area under the curve based scoring system, with higher scores meaning better performance

  5. Tactile functional object recognition

    Time frame: 1 day

    Clinical assessment of sensory processing on an ordinal scale ranging from 0 to 42, with higher scores meaning better performance

  6. Stereognosis section of the original Nottingham sensory assessment

    Time frame: 1 day

    Clinical assessment of sensory processing on an ordinal scale ranging from 0 to 22, with higher scores meaning better performance

  7. Wrist position sense test

    Time frame: 1 day

    Clinical assessment of wrist position sense on a continuous scale, with lower scores meaning better performance

  8. Perceptual threshold of touch

    Time frame: 1 day

    TENS-based assessment of exteroception on a continuous scale, with lower scores meaning better performance

  9. Fugl-Meyer upper extremity assessment

    Time frame: 1 day

    Clinical assessment of motor function on an ordinal scale ranging from 0 to 66, with higher scores meaning better performance

  10. Action research arm test

    Time frame: 1 day

    Clinical assessment of motor activity performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance

  11. Barthel index

    Time frame: 1 day

    Clinical assessment of activities of daily living on an ordinal scale ranging from 0 to 20, with higher scores meaning better performance

  12. Montreal cognitive assessment

    Time frame: 1 day

    Clinical assessment of cognitive function on an ordinal scale ranging from 0 to 30, with higher scores meaning better performance

  13. Star cancellation test

    Time frame: 1 day

    Clinical assessment of visuospatial neglect on an ordinal scale ranging from 0 to 54, with higher scores meaning better performance, and a score below 44 indicating the presence of visuospatial neglect

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2024
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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