NCT04721561

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, the investigators have developed a robotic assessment of sensory processing. During this study, the investigators aim to initially validate this novel assessment. The investigators aim to examine 20 chronic stroke patients and 20 age-matched healthy controls using the robotic assessment on one hand, and a set of existing clinical assessments on the other hand. The investigators hypothesize that stroke patients will have a poorer performance on this novel robotic assessment compared to age-matched healthy controls, and that these findings are similar to what is found with existing clinical assessments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

January 19, 2021

Last Update Submit

March 28, 2023

Conditions

Stroke

Keywords

StrokeUpper limbSomatosensationSensory processingRobotic assessmentKinematics

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (13)

  • 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)

  • Tactile functional object recognition

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

  • +8 more secondary outcomes

Study Arms (2)

Chronic stroke patients

Patients who are at least 6 months after a first unilateral stroke

Healthy controls

Healthy subjects with no history of any neurological condition and who are in the same age group as the chronic stroke patients

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:

  • At least 18 years old
  • A first-ever unilateral, supratentorial stroke (as defined by WHO)
  • In the chronic phase after stroke (i.e. being at least 6 months after stroke)
  • The ability to perform, at least to some extent, active shoulder abduction and wrist extension against gravity

You may not qualify if:

  • Any serious musculoskeletal and/or other neurological conditions
  • Serious communication or cognitive deficits
  • No written informed consent
  • \- At least 18 years old
  • 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

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Geert Verheyden

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
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 22, 2021

Study Start

December 18, 2019

Primary Completion

December 22, 2020

Study Completion

December 22, 2020

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

BE(1)