- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04723212
Robotic Assessment of Upper Limb Passive and Active Sensory Processing in Healthy Adults
The Effect of Cognition and Age on Robotic Assessment of Upper Limb Passive and Active Sensory Processing
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Leuven, Belgium, 3001
- KU Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Geert Verheyden, KU Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
PfizerRecruitingHealthy | Healthy AdultsUnited States
-
Atisama TherapeuticsRecruitingHealthy | Healthy SmokerAustralia