Validity and Reliability of Sensorimotor Processing Paradigm

NCT06382558 | Completed

• 2 other identifiers: s68470C2M/23/060
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal assessment for sensory processing, one of the most important sensory functions, does not exists. However, our research team has developed a novel assessment paradigm using the KINARM End-Point robot to assess the level of sensory processing of the upper limb. Within a previous study, the investigators examined the validity within 20 chronic stroke patients and 80 age-matched healthy controls by comparing the novel robotic assessment with a set of existing clinical and robotic assessments for the upper limb. The investigators hypothesize that the stroke patients will show a poorer performance on this novel assessment compared to the healthy controls, that the novel assessment will show better correlation coefficients with other sensory tests compared to motor tests, that the novel assessment can differentiate between different motor subgroups of chronic stroke patients, and that the novel assessment shows good test-retest reliability.

Conditions

Stroke

Keywords

Stroke; Upper limb; Somatosensation; Sensory processing; Robotic assessment; Kinematics

Outcome Measures

Primary Outcomes (1)

• Kinarm: Passive and active discrimination task

  Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing

  up to 2 days

Secondary Outcomes (13)

• Kinarm: Arm position matching task

  1 day

• Kinarm: Visually guided reaching task

  1 day

• Erasmus modified Nottingham sensory assessment

  1 day

• Tactile discrimination test

  1 day

• Tactile functional object recognition

  1 day

Study Arms (2)

Chronic stroke patients

Patients who experienced a first unilateral stroke at least 6 months ago

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants will be recruited from the community sample

You may qualify if:

• Written informed consent must be obtained prior to any screening procedures
• First-ever unilateral, supra-tentorial stroke (as defined by WHO)
• At least 18 years old
• Being in the chronic phase after stroke (i.e. being at least 6 months after stroke)
• Motor impairment in the upper limb, defined as Fugl-Meyer score \>22 out of 66 to demonstrate moderate to full upper limb motor function (patients scoring \<23 out of 66 will not be able to comply with the KINARM protocol)

You may not qualify if:

• Any serious musculoskeletal and/or other neurological disorders
• Severe communication or cognitive deficits that interfere with the protocol
• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, 3001, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular 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. Geert Verheyden

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 24, 2024
• Study Start: April 10, 2024
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

BE (1)