Robotic Evaluations of Motor Learning During Stroke Neurorehabilitation (RELEARN)

University of Calgary

Status: Enrolling

Conditions: Stroke

Treatments: Other: Magnetic Resonance Imaging (MRI); Other: Clinical Assessment; Device: Kinarm Robotic Exoskeleton Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT05106140

REB21-0441

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

300 participants in 2 patient groups

Stroke Participants

Description:

This group will include stroke survivors from the Calgary Stroke Program who are over 18 years of age.

Treatment:

Other: Magnetic Resonance Imaging (MRI)

Other: Clinical Assessment

Device: Kinarm Robotic Exoskeleton Assessment

Control Participants

Description:

This group will include healthy individuals from the community who are matched for age and sex to stroke participants.

Treatment:

Other: Clinical Assessment

Device: Kinarm Robotic Exoskeleton Assessment