Clinical trial NCT05106140: Robotic Evaluations of Motor Learning During Stroke Neurorehabilitation
Official title: Robotic Evaluations of Motor Learning During Stroke Neurorehabilitation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: Rehabilitation
Neuroimaging
Motor Learning
Early Stroke Recovery
Neuroplasticity
Limb Dominance
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-11-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: In stroke rehabilitation, clinicians guide the relearning of motor skills to promote recovery and improve function. A common assumption is that motor learning interacts with processes that are involved in tissue repair and helps to engage neuroplastic mechanisms that promote recovery. One of the biggest roadblocks for advancing the treatment of motor deficits is that we do not understand how motor learning changes after stroke, and critically, if poor recovery is due to a loss in an individual's ability to adapt or learn. Existing clinical tests do not directly assess motor learning. This means that therapists can profile stroke impairments (motor, sensory, cognitive, etc.) but cannot directly measure a patient's ability to learn, which is likely an important factor in recovery.

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.

Eligibility criteria: Inclusion Criteria for Stroke Participants:

* First time, unilateral ischemic stroke in middle cerebral artery territory, motor and/or sensory tracts and confirmed by clinical examination (including neuroimaging)
* 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

Inclusion Criteria for Control Participants:

* \>18 years old
* Good health

Exclusion Criteria for Stroke Participants:

* History of:

  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

Exclusion Criteria for Control Participants:

• Significant upper limb neurologic or orthopedic conditions

Primary outcomes:
measure: Changes in Path Deviations
timeFrame: Control participant: baseline only; Stroke participant: week 1 and week 26
measure: Peak Lateral Deviations
timeFrame: Control participant: baseline only; Stroke participant: week 1
measure: Peak Lateral Deviations
timeFrame: Stroke participant: week 26
Secondary outcomes:
measure: Robotic Assessment
timeFrame: Control participant: baseline; Stroke participant: week 1, week 6, week 12, and week 26
measure: Motor Learning
timeFrame: Control participant: baseline only; Stroke participant: week 1 and week 26
measure: Arm Reflexes
timeFrame: Stroke participant only: week 1, week 6, week 12, and week 26
measure: Modified Ashworth Scale (MAS)
timeFrame: Stroke participant only: week 1, week 6, week 12, and week 26
measure: Strength
timeFrame: Stroke participant only: week 1, week 6, week 12, and week 26
measure: Apraxia
timeFrame: Stroke participant only: week 1, week 6, week 12, and week 26
measure: Thumb Localizing Test
timeFrame: Stroke participant only: week 1, week 6, week 12, and week 26
measure: Chedoke-McMaster Stroke Assessment-Impairment Inventory
timeFrame: Stroke participant only: week 1, week 6, week 12, and week 26
measure: Fugl-Meyer Upper Extremity Assessment (FMA)
timeFrame: Stroke participant only: week 1, week 6, week 12, and week 26
measure: Functional Independence Measure (FIM)
timeFrame: Stroke participant only: week 1, week 6, week 12, and week 26
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Stroke participant only: week 1, week 6, week 12, and week 26
measure: Magnetic Resonance Imaging (MRI)
timeFrame: Stroke participant only: week 6
measure: Standard of Care Rehabilitation Therapy
timeFrame: Stroke participant only: two days between week 1 and week 26
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Carewest Dr. Vernon Fanning Centre
state: Alberta
city: Calgary
country: Canada
facility: University of Calgary - Kinesiology Building
state: Alberta
city: Calgary
country: Canada
facility: Foothills Hospital - Main Building
state: Alberta
city: Calgary
country: Canada
facility: University of Calgary - Teaching Research and Wellness (TRW) Building
state: Alberta
Study officials:
affiliation: University of Calgary, Calgary, Alberta, Canada
name: Tyler Cluff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary, Calgary, Alberta, Canada
name: Sean Dukelow, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: