Stroke Clinical Trial
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.
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | KU Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
KU Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kinarm: Passive and active discrimination task | Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing | up to 2 days | |
Secondary | Kinarm: Arm position matching task | Assessment of limb position sense using a 9-target mirror-matching task on the Kinarm End-Point Lab | 1 day | |
Secondary | Kinarm: Visually guided reaching task | Assessment of motor function using a 4-target centre-out reaching task on the Kinarm End-Point Lab | 1 day | |
Secondary | Erasmus modified Nottingham sensory assessment | Clinical assessment of sensory processing with an area under the curve based scoring system, with higher scores meaning better performance | 1 day | |
Secondary | Tactile discrimination test | Clinical assessment of sensory processing with an area under the curve based scoring system, with higher scores meaning better performance | 1 day | |
Secondary | Tactile functional object recognition | Clinical assessment of sensory processing on an ordinal scale ranging from 0 to 42, with higher scores meaning better performance | 1 day | |
Secondary | Stereognosis section of the original Nottingham sensory assessment | Clinical assessment of sensory processing on an ordinal scale ranging from 0 to 22, with higher scores meaning better performance | 1 day | |
Secondary | Wrist position sense test | Clinical assessment of wrist position sense on a continuous scale, with lower scores meaning better performance | 1 day | |
Secondary | Perceptual threshold of touch | TENS-based assessment of exteroception on a continuous scale, with lower scores meaning better performance | 1 day | |
Secondary | Fugl-Meyer upper extremity assessment | Clinical assessment of motor function on an ordinal scale ranging from 0 to 66, with higher scores meaning better performance | 1 day | |
Secondary | Action research arm test | Clinical assessment of motor activity performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance | 1 day | |
Secondary | Barthel index | Clinical assessment of activities of daily living on an ordinal scale ranging from 0 to 20, with higher scores meaning better performance | 1 day | |
Secondary | Montreal cognitive assessment | Clinical assessment of cognitive function on an ordinal scale ranging from 0 to 30, with higher scores meaning better performance | 1 day | |
Secondary | Star cancellation test | 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 | 1 day |
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