Robotic Evaluations of Motor Learning During Stroke Neurorehabilitation
NCT ID: NCT05106140
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2021-09-20
2026-09-01
Brief Summary
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Detailed Description
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The RELEARN trial will pair robotics, an objective tool to assess post-stroke arm impairment, with neuroimaging to link motor learning deficits with possible influencing factors (sensory, motor, cognitive function) and damage in specific brain areas.
Participants with stroke will undergo clinical and robotic evaluations at baseline (within 1-13 days post-stroke), at 6 weeks, at 12 weeks, and again at 26 weeks. An MRI assessment will occur during week 6. Stroke participants will complete a 24hr retention assessment after baseline visit and week 26 visit.
Control participants will undergo a single robotic evaluation and a 24hr retention assessment.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Stroke Participants
This group will include stroke survivors from the Calgary Stroke Program who are over 18 years of age.
Magnetic Resonance Imaging (MRI)
A research MRI will be performed at 6-weeks post-stroke to document stroke lesion location and size.
Kinarm Robotic Exoskeleton Assessment
The Kinarm Robotic Exoskeleton is a device used to provide therapy and assessment. The device has framework that supports the arms and these supports are adjustable to ensure a comfortable fit. Motors attached to the framework move the arms and record shoulder and elbow movements.
The assessment involves performing a number of tasks using the Kinarm to measure proprioceptive and motor impairment, adaptation to force and visual disturbances, and retention after 24 hours.
Clinical Assessment
The clinical assessment will be performed by a qualified stroke therapist and include a number of verified measurements to examine: reflexes, strength, apraxia, somatosensation, physical abilities, and cognition.
Control Participants
This group will include healthy individuals from the community who are matched for age and sex to stroke participants.
Kinarm Robotic Exoskeleton Assessment
The Kinarm Robotic Exoskeleton is a device used to provide therapy and assessment. The device has framework that supports the arms and these supports are adjustable to ensure a comfortable fit. Motors attached to the framework move the arms and record shoulder and elbow movements.
The assessment involves performing a number of tasks using the Kinarm to measure proprioceptive and motor impairment, adaptation to force and visual disturbances, and retention after 24 hours.
Clinical Assessment
The clinical assessment will be performed by a qualified stroke therapist and include a number of verified measurements to examine: reflexes, strength, apraxia, somatosensation, physical abilities, and cognition.
Interventions
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Magnetic Resonance Imaging (MRI)
A research MRI will be performed at 6-weeks post-stroke to document stroke lesion location and size.
Kinarm Robotic Exoskeleton Assessment
The Kinarm Robotic Exoskeleton is a device used to provide therapy and assessment. The device has framework that supports the arms and these supports are adjustable to ensure a comfortable fit. Motors attached to the framework move the arms and record shoulder and elbow movements.
The assessment involves performing a number of tasks using the Kinarm to measure proprioceptive and motor impairment, adaptation to force and visual disturbances, and retention after 24 hours.
Clinical Assessment
The clinical assessment will be performed by a qualified stroke therapist and include a number of verified measurements to examine: reflexes, strength, apraxia, somatosensation, physical abilities, and cognition.
Eligibility Criteria
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Inclusion Criteria
* 7±6 days post-stroke
* Upper limb impairment
* \>18 years old
* Fugl-Meyer upper extremity score between 30 and 57
* Vision better than 20/50 (corrected)
* Able to follow 3-step task commands
* \>18 years old
* Good health
Exclusion Criteria
1. past undiagnosed stroke (evident on neuroimaging),
2. neglect (screened with Behavioral Inattention Test),
3. apraxia, or
4. upper extremity orthopedic or muscular issues
* Secondary neurologic injury or disease (e.g., Parkinson's)
* Contraindication to MRI
* Medical or neuropsychiatric conditions that would interfere with study outcomes, or where participation presents a risk to the subject
* Enrollment in an interventional trial that supplements standard therapy
• Significant upper limb neurologic or orthopedic conditions
18 Years
ALL
Yes
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Tyler Cluff, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary, Calgary, Alberta, Canada
Sean Dukelow, MD PhD FRCPC
Role: PRINCIPAL_INVESTIGATOR
University of Calgary, Calgary, Alberta, Canada
Locations
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Carewest Dr. Vernon Fanning Centre
Calgary, Alberta, Canada
University of Calgary - Kinesiology Building
Calgary, Alberta, Canada
Foothills Hospital - Main Building
Calgary, Alberta, Canada
University of Calgary - Teaching Research and Wellness (TRW) Building
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Sean Dukelow, MD PhD FRCPC
Role: primary
Tyler Cluff, PhD
Role: primary
Sean Dukelow, MD PhD FRCPC
Role: primary
Sean Dukelow, MD PhD FRCPC
Role: primary
Other Identifiers
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REB21-0441
Identifier Type: -
Identifier Source: org_study_id