Robotic Evaluations of Motor Learning During Stroke Neurorehabilitation

Overview

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.

Interventions

• Other Magnetic Resonance Imaging (MRI)
  A research MRI will be performed at 6-weeks post-stroke to document stroke lesion location and size.
• Device 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.
• Other 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.

Primary outcome measures

• Changes in Path Deviations [Time frame: Control participant: baseline only; Stroke participant: week 1 and week 26]
• Peak Lateral Deviations [Time frame: Control participant: baseline only; Stroke participant: week 1]
• Peak Lateral Deviations [Time frame: Stroke participant: week 26]

Secondary outcome measures (12)

• Robotic Assessment [Time frame: Control participant: baseline; Stroke participant: week 1, week 6, week 12, and week 26]
• Motor Learning [Time frame: Control participant: baseline only; Stroke participant: week 1 and week 26]
• Arm Reflexes [Time frame: Stroke participant only: week 1, week 6, week 12, and week 26]
• Modified Ashworth Scale (MAS) [Time frame: Stroke participant only: week 1, week 6, week 12, and week 26]
• Strength [Time frame: Stroke participant only: week 1, week 6, week 12, and week 26]
• Apraxia [Time frame: Stroke participant only: week 1, week 6, week 12, and week 26]
• Thumb Localizing Test [Time frame: Stroke participant only: week 1, week 6, week 12, and week 26]
• Chedoke-McMaster Stroke Assessment-Impairment Inventory [Time frame: Stroke participant only: week 1, week 6, week 12, and week 26]
• Fugl-Meyer Upper Extremity Assessment (FMA) [Time frame: Stroke participant only: week 1, week 6, week 12, and week 26]
• Functional Independence Measure (FIM) [Time frame: Stroke participant only: week 1, week 6, week 12, and week 26]
• Montreal Cognitive Assessment (MoCA) [Time frame: Stroke participant only: week 1, week 6, week 12, and week 26]
• Magnetic Resonance Imaging (MRI) [Time frame: Stroke participant only: week 6]

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:

• 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

Exclusion Criteria for Control Participants:

• Significant upper limb neurologic or orthopedic conditions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Canada · 4 centers

• Carewest Dr. Vernon Fanning Centre — Calgary
• University of Calgary - Kinesiology Building — Calgary
• Foothills Hospital - Main Building — Calgary
• University of Calgary - Teaching Research and Wellness (TRW) Building — Calgary

Identifiers

NCT: NCT05106140 · REB21-0441

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗