NCT06382558Completed
Validity and Reliability of Sensorimotor Processing Paradigm
Evaluating Validity and Reliability of a Novel In-house Developed, Robot-based Sensorimotor Processing Assessment Paradigm for the Upper Limb in the Chronic Phase After Stroke.
Source: ClinicalTrials.gov · Last updated 15 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 44 (actual)
- First submitted
- 18 Apr 2024
- Start date
- 10 Apr 2024
- Primary completion date
- 19 Mar 2025
- Lead sponsor
- KU Leuven
- Diseases
- Stroke
- NCT number
- NCT06382558
What you commit to
- Study type: Observational
- Participants enrolled: 44
- From 10 Apr 2024 to the primary completion date, 19 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any serious musculoskeletal and/or other neurological disorders
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
Other
- Severe communication or cognitive deficits that interfere with the protocol
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| KU Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.