Clinical trial NCT04721561: Towards Understanding Upper Limb Rehabilitation After Stroke
Official title: Robotic Assessment of Upper Limb Passive and Active Sensory Processing 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
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2021-01-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All participants will be recruited from the community sample.

Brief summary: After a stroke, more than two out of three patients experience problems with upper limb movement and sensation. During the past decade, robotic technology has been increasingly used to asses these problems in a detailed and accurate manner. However, sensory processing, one of the most important sensory functions, has not been assessed using robotic technology yet. Therefore, the investigators have developed a robotic assessment of sensory processing. During this study, the investigators aim to initially validate this novel assessment. The investigators aim to examine 20 chronic stroke patients and 20 age-matched healthy controls using the robotic assessment on one hand, and a set of existing clinical assessments on the other hand. The investigators hypothesize that stroke patients will have a poorer performance on this novel robotic assessment compared to age-matched healthy controls, and that these findings are similar to what is found with existing clinical assessments.

Detailed description: Up to 70% of stroke survivors show upper limb impairments consisting of motor and/or somatosensory impairments. These impairments often persist well into the chronic stage, and may lead to significant limitations in activities of daily living and may negatively affect quality of life. It is therefore of utmost importance to accurately assess upper limb impairments. Clinical assessments exist for both motor and somatosensory function, but lack good psychometric properties. Robotic technology 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.

The investigators recently developed a novel robotic assessment of sensory processing, using the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada). This cross-sectional 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 20 age-matched controls will be recruited and will undergo extensive clinical and robotic assessment of upper limb motor and somatosensory function. The investigators hypothesize stoke patients with sensory processing deficits to have a worse performance on this novel robotic assessment compared to healthy controls and patients without sensory processing deficits. The investigators also hypothesize to see moderate to high correlations between the robotic assessment of sensory processing, and clinical assessments for both somatosensory and motor function.

Eligibility criteria: Inclusion Criteria - Stroke Patients:

* At least 18 years old
* A first-ever unilateral, supratentorial stroke (as defined by WHO)
* In the chronic phase after stroke (i.e. being at least 6 months after stroke)
* The ability to perform, at least to some extent, active shoulder abduction and wrist extension against gravity

Exclusion Criteria - Stroke Patients:

* Any serious musculoskeletal and/or other neurological conditions
* Serious communication or cognitive deficits
* No written informed consent

Inclusion Criteria - Healthy Controls:

- At least 18 years old

Exclusion Criteria - Healthy Controls:

* History of stroke or TIA
* Upper limb somatosensory and/or motor impairments
* Any serious musculoskeletal and/or other neurological conditions
* Serious communication or cognitive deficits
* No written informed consent

Primary outcomes:
measure: Kinarm: sensory processing task
timeFrame: Once in the chronic phase (at least 6 months after stroke)
Secondary outcomes:
measure: Kinarm: position matching task
timeFrame: Once in the chronic phase (at least 6 months after stroke)
measure: Kinarm: visually guided reaching
timeFrame: Once in the chronic phase (at least 6 months after stroke)
measure: Erasmus modified Nottingham sensory assessment
timeFrame: Once in the chronic phase (at least 6 months after stroke)
measure: Tactile discrimination test
timeFrame: Once in the chronic phase (at least 6 months after stroke)
measure: Tactile functional object recognition
timeFrame: Once in the chronic phase (at least 6 months after stroke)
measure: Stereognosis section of the original Nottingham sensory assessment
timeFrame: Once in the chronic phase (at least 6 months after stroke)
measure: Wrist position sense test
timeFrame: Once in the chronic phase (at least 6 months after stroke)
measure: Perceptual threshold of touch
timeFrame: Once in the chronic phase (at least 6 months after stroke)
measure: Fugl-Meyer upper extremity assessment
timeFrame: Once in the chronic phase (at least 6 months after stroke)
measure: Action research arm test
timeFrame: Once in the chronic phase (at least 6 months after stroke)
measure: Barthel index
timeFrame: Once in the chronic phase (at least 6 months after stroke)
measure: Montreal cognitive assessment
timeFrame: Once in the chronic phase (at least 6 months after stroke)
measure: Star cancellation test
timeFrame: Once in the chronic phase (at least 6 months after stroke)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
affiliation: KU Leuven
name: Geert Verheyden
role: PRINCIPAL_INVESTIGATOR
References: