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

March 28, 2023 updated by: Prof Geert Verheyden, KU Leuven

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Leuven, Belgium, 3001
        • KU Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All participants will be recruited from the community sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Younger healthy adults
Healthy subjects in the age group of 18-30 years old, and without history of any neurological condition
Older healthy adults
Healthy subjects aged 55 years and older, and without history of any neurological condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Once in the chronic phase (at least 6 months after stroke)
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.
Once in the chronic phase (at least 6 months after stroke)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Once in the chronic phase (at least 6 months after stroke)
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
Once in the chronic phase (at least 6 months after stroke)
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
Once in the chronic phase (at least 6 months after stroke)
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
Once in the chronic phase (at least 6 months after stroke)
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
Once in the chronic phase (at least 6 months after stroke)
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
Once in the chronic phase (at least 6 months after stroke)
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
Once in the chronic phase (at least 6 months after stroke)
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
Once in the chronic phase (at least 6 months after stroke)
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
Once in the chronic phase (at least 6 months after stroke)
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
Once in the chronic phase (at least 6 months after stroke)
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
Once in the chronic phase (at least 6 months after stroke)
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
Once in the chronic phase (at least 6 months after stroke)
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
Once in the chronic phase (at least 6 months after stroke)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Geert Verheyden, KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Actual)

January 20, 2021

Study Completion (Actual)

January 20, 2021

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • C22/18/008 (Other Grant/Funding Number: KU Leuven C2 internal fund)
  • S61997 (Ethische commissie onderzoek UZ/KU Leuven)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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