KU Leuven
Leuven, 3001, Belgium
NCT Number: NCT06382558
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Leuven, 3001, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: up to 2 days
Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing
Time frame: 1 day
Assessment of limb position sense using a 9-target mirror-matching task on the Kinarm End-Point Lab
Time frame: 1 day
Assessment of motor function using a 4-target centre-out reaching task on the Kinarm End-Point Lab
Time frame: 1 day
Clinical assessment of sensory processing with an area under the curve based scoring system, with higher scores meaning better performance
Time frame: 1 day
Clinical assessment of sensory processing with an area under the curve based scoring system, with higher scores meaning better performance
Time frame: 1 day
Clinical assessment of sensory processing on an ordinal scale ranging from 0 to 42, with higher scores meaning better performance
Time frame: 1 day
Clinical assessment of sensory processing on an ordinal scale ranging from 0 to 22, with higher scores meaning better performance
Time frame: 1 day
Clinical assessment of wrist position sense on a continuous scale, with lower scores meaning better performance
Time frame: 1 day
TENS-based assessment of exteroception on a continuous scale, with lower scores meaning better performance
Time frame: 1 day
Clinical assessment of motor function on an ordinal scale ranging from 0 to 66, with higher scores meaning better performance
Time frame: 1 day
Clinical assessment of motor activity performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance
Time frame: 1 day
Clinical assessment of activities of daily living on an ordinal scale ranging from 0 to 20, with higher scores meaning better performance
Time frame: 1 day
Clinical assessment of cognitive function on an ordinal scale ranging from 0 to 30, with higher scores meaning better performance
Time frame: 1 day
Clinical assessment of visuospatial neglect on an ordinal scale ranging from 0 to 54, with higher scores meaning better performance, and a score below 44 indicating the presence of visuospatial neglect
KU Leuven
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06750692
Brain Diseases, Cardiovascular Diseases
Afyonkarahisar, Turkey (Türkiye)
View Trial DetailsNCT04992195
Alzheimer Disease, Arterial Thromboembolism
Hong Kong
View Trial DetailsNCT07736573
Brain Diseases, Cardiovascular Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT07237633
Brain Diseases, Cardiovascular Diseases
Singapore
View Trial Details