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Clinical Trials/NCT04721561
NCT04721561
Completed
N/A

Robotic Assessment of Upper Limb Passive and Active Sensory Processing in the Chronic Phase After Stroke

KU Leuven1 site in 1 country44 target enrollmentDecember 18, 2019
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
KU Leuven
Enrollment
44
Locations
1
Primary Endpoint
Kinarm: sensory processing task
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 18, 2019
End Date
December 22, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
KU Leuven
Responsible Party
Principal Investigator
Principal Investigator

Prof Geert Verheyden

Prof. Dr.

KU Leuven

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Kinarm: sensory processing task

Time Frame: Once in the chronic phase (at least 6 months after stroke)

Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing

Secondary Outcomes

  • Kinarm: position matching task(Once in the chronic phase (at least 6 months after stroke))
  • Erasmus modified Nottingham sensory assessment(Once in the chronic phase (at least 6 months after stroke))
  • Tactile discrimination test(Once in the chronic phase (at least 6 months after stroke))
  • Action research arm test(Once in the chronic phase (at least 6 months after stroke))
  • Kinarm: visually guided reaching(Once in the chronic phase (at least 6 months after stroke))
  • Perceptual threshold of touch(Once in the chronic phase (at least 6 months after stroke))
  • Stereognosis section of the original Nottingham sensory assessment(Once in the chronic phase (at least 6 months after stroke))
  • Tactile functional object recognition(Once in the chronic phase (at least 6 months after stroke))
  • Wrist position sense test(Once in the chronic phase (at least 6 months after stroke))
  • Fugl-Meyer upper extremity assessment(Once in the chronic phase (at least 6 months after stroke))
  • Barthel index(Once in the chronic phase (at least 6 months after stroke))
  • Montreal cognitive assessment(Once in the chronic phase (at least 6 months after stroke))
  • Star cancellation test(Once in the chronic phase (at least 6 months after stroke))

Study Sites (1)

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