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Completed

NCT Number: NCT04723212

Robotic Assessment of Upper Limb Passive and Active Sensory Processing in Healthy Adults

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

KU Leuven

Leuven, 3001, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18-30 years old; or aged 55+

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Kinarm: sensory processing task

    Time frame: 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

  2. Kinarm: working memory task

    Time frame: 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.

Secondary outcomes

  1. Montreal cognitive assessment

    Time frame: Once in the chronic phase (at least 6 months after stroke)

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

  2. Kinarm: position matching task

    Time frame: Once in the chronic phase (at least 6 months after stroke)

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

  3. Kinarm: visually guided reaching

    Time frame: Once in the chronic phase (at least 6 months after stroke)

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

  4. Erasmus modified Nottingham sensory assessment

    Time frame: Once in the chronic phase (at least 6 months after stroke)

    Clinical assessment of somatosensory function (including exteroception, proprioception and sensory processing) on an ordinal scale ranging from 0 to 40, with higher scores meaning better performance

  5. Tactile discrimination test

    Time frame: Once in the chronic phase (at least 6 months after stroke)

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

  6. Tactile functional object recognition

    Time frame: Once in the chronic phase (at least 6 months after stroke)

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

  7. Stereognosis section of the original Nottingham sensory assessment

    Time frame: Once in the chronic phase (at least 6 months after stroke)

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

  8. Wrist position sense test

    Time frame: Once in the chronic phase (at least 6 months after stroke)

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

  9. Perceptual threshold of touch

    Time frame: Once in the chronic phase (at least 6 months after stroke)

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

  10. Fugl-Meyer upper extremity assessment

    Time frame: Once in the chronic phase (at least 6 months after stroke)

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

  11. Action research arm test

    Time frame: Once in the chronic phase (at least 6 months after stroke)

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

  12. Barthel index

    Time frame: Once in the chronic phase (at least 6 months after stroke)

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

  13. Star cancellation test

    Time frame: Once in the chronic phase (at least 6 months after stroke)

    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

Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2021
Registry last updated
Mar 29, 2023

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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