Robotic Evaluations of Motor Learning During Stroke Neurorehabilitation
RELEARN
1 other identifier
observational
300
1 country
4
Brief Summary
The RELEARN trial is a a prospective longitudinal cohort study sampled by convenience. Stroke survivors and healthy control individuals will be recruited to analyze motor learning in the upper extremity and its neural basis in early stroke recovery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2021
CompletedStudy Start
First participant enrolled
September 20, 2021
CompletedFirst Posted
Study publicly available on registry
November 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
November 3, 2021
July 1, 2021
5 years
May 31, 2021
November 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Changes in Path Deviations
Initial path deviations (IPDs) will be measured during each robotic task movement and used to measure learning in each session.
Control participant: baseline only; Stroke participant: week 1 and week 26
Peak Lateral Deviations
Peak lateral deviations (PLDs) will be measured during each robotic task movement and used to measure learning in each session.
Control participant: baseline only; Stroke participant: week 1
Peak Lateral Deviations
Peak lateral deviations (PLDs) will be measured during each robotic task movement and used to measure learning in each session.
Stroke participant: week 26
Secondary Outcomes (13)
Robotic Assessment
Control participant: baseline; Stroke participant: week 1, week 6, week 12, and week 26
Motor Learning
Control participant: baseline only; Stroke participant: week 1 and week 26
Arm Reflexes
Stroke participant only: week 1, week 6, week 12, and week 26
Modified Ashworth Scale (MAS)
Stroke participant only: week 1, week 6, week 12, and week 26
Strength
Stroke participant only: week 1, week 6, week 12, and week 26
- +8 more secondary outcomes
Study Arms (2)
Stroke Participants
This group will include stroke survivors from the Calgary Stroke Program who are over 18 years of age.
Control Participants
This group will include healthy individuals from the community who are matched for age and sex to stroke participants.
Interventions
A research MRI will be performed at 6-weeks post-stroke to document stroke lesion location and size.
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.
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
Patients who are 7±6 days post-stroke from the Calgary Stroke Program will be included in this study, as well as healthy control volunteers from the community.
You may qualify if:
- First time, unilateral ischemic stroke in middle cerebral artery territory, motor and/or sensory tracts and confirmed by clinical examination (including neuroimaging)
- ±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
You may not qualify if:
- History of:
- past undiagnosed stroke (evident on neuroimaging),
- neglect (screened with Behavioral Inattention Test),
- apraxia, or
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Carewest Dr. Vernon Fanning Centre
Calgary, Alberta, T2E 6V7, Canada
University of Calgary - Kinesiology Building
Calgary, Alberta, T2N 1N4, Canada
Foothills Hospital - Main Building
Calgary, Alberta, T2N2T9, Canada
University of Calgary - Teaching Research and Wellness (TRW) Building
Calgary, Alberta, T2N2T9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tyler Cluff, PhD
University of Calgary, Calgary, Alberta, Canada
- PRINCIPAL INVESTIGATOR
Sean Dukelow, MD PhD FRCPC
University of Calgary, Calgary, Alberta, Canada
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2021
First Posted
November 3, 2021
Study Start
September 20, 2021
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
November 3, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share