Validity and Reliability of Sensorimotor Processing Paradigm

NCT ID: NCT06382558

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-10
• Study Completion Date: 2025-03-19

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.

Detailed Description

Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). These impairments may lead to significant limitations in activities of daily living and may negatively affect quality of life. It is therefore of importance to accurately assess upper limb impairments. Clinical assessments exist for both motor and somatosensory function, but lack good psychometric properties. Robotics 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.

Within a previous study of our research team, a novel robotic assessment of sensory processing was developed, using the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada). That study was set up to initially validate this novel robotic assessment and to collect pilot data to form the basis for future research. 20 chronic stroke patients and 80 age-matched controls underwent extensive clinical and robotic assessment of upper limb motor and somatosensory function. For the cross-sectional study, the investigators aim to build further on this previous research. By recruiting 60 additional chronic stroke patients and combining both data of the previous study and this study, the investigators aim to examine the validity and reliability of this novel assessment in a bigger and more heterogeneous group of chronic stroke participants. The investigators hypothesize that stoke patients have a worse performance on this novel robotic assessment compared to healthy controls, that the novel assessment correlates more to standard sensory assessments compared to standard motor assessments, that the novel assessment can differentiate between motor subgroups of chronic stroke patients, and that the novel assessment shows good test-retest reliability.

Conditions

Stroke

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Chronic stroke patients

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

No interventions assigned to this group

Healthy controls

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Written informed consent must be obtained prior to any screening procedures

2. First-ever unilateral, supra-tentorial stroke (as defined by WHO)

3. At least 18 years old

4. Being in the chronic phase after stroke (i.e. being at least 6 months after stroke)

5. 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)

Exclusion Criteria

1. Any serious musculoskeletal and/or other neurological disorders

2. Severe communication or cognitive deficits that interfere with the protocol

3. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Prof Geert Verheyden

Prof. Dr. Geert Verheyden

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geert Verheyden

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

KU Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

C2M/23/060

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

s68470

Identifier Type: -

Identifier Source: org_study_id