Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382558
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-18
Brief Title:
Validity and Reliability of Sensorimotor Processing Paradigm
Sponsor:
KU Leuven
Organization:
KU Leuven
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C2M23060 | OTHER_GRANT | KU Leuven | None |