Clinical trial NCT06382558: Validity and Reliability of Sensorimotor Processing Paradigm
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
Upper limb
Somatosensation
Sensory processing
Robotic assessment
Kinematics
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will be recruited from the community sample

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.

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.

Primary outcomes:
measure: Kinarm: Passive and active discrimination task
timeFrame: up to 2 days
Secondary outcomes:
measure: Kinarm: Arm position matching task
timeFrame: 1 day
measure: Kinarm: Visually guided reaching task
timeFrame: 1 day
measure: Erasmus modified Nottingham sensory assessment
timeFrame: 1 day
measure: Tactile discrimination test
timeFrame: 1 day
measure: Tactile functional object recognition
timeFrame: 1 day
measure: Stereognosis section of the original Nottingham sensory assessment
timeFrame: 1 day
measure: Wrist position sense test
timeFrame: 1 day
measure: Perceptual threshold of touch
timeFrame: 1 day
measure: Fugl-Meyer upper extremity assessment
timeFrame: 1 day
measure: Action research arm test
timeFrame: 1 day
measure: Barthel index
timeFrame: 1 day
measure: Montreal cognitive assessment
timeFrame: 1 day
measure: Star cancellation test
timeFrame: 1 day
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
affiliation: KU Leuven
name: Geert Verheyden
role: PRINCIPAL_INVESTIGATOR
References: