NCT04723212

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

January 19, 2021

Last Update Submit

March 28, 2023

Conditions

Keywords

Healthy controlsUpper limbSomatosensationSensory processingRobotic assessmentKinematics

Outcome Measures

Primary Outcomes (2)

  • Kinarm: sensory processing task

    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

    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 Outcomes (13)

  • Montreal cognitive assessment

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

  • Kinarm: position matching task

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

  • Kinarm: visually guided reaching

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

  • Erasmus modified Nottingham sensory assessment

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

  • Tactile discrimination test

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

  • +8 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All participants will be recruited from the community sample

You may qualify if:

  • \- Aged 18-30 years old; or aged 55+

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven

Leuven, 3001, Belgium

Location

Study Officials

  • Geert Verheyden

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 25, 2021

Study Start

June 10, 2020

Primary Completion

January 20, 2021

Study Completion

January 20, 2021

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations