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.
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.
Study Type
OBSERVATIONAL
Enrollment
300
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.
Carewest Dr. Vernon Fanning Centre
Calgary, Alberta, Canada
RECRUITINGUniversity of Calgary - Kinesiology Building
Calgary, Alberta, Canada
RECRUITINGFoothills Hospital - Main Building
Calgary, Alberta, Canada
RECRUITINGChanges in Path Deviations
Initial path deviations (IPDs) will be measured during each robotic task movement and used to measure learning in each session.
Time frame: 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.
Time frame: 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.
Time frame: Stroke participant: week 26
Robotic Assessment
The robotic assessment consists of a number of upper limb tests of neurologic function which have been validated against standard clinical measures. Tasks include: Visually Guided Reaching, Limb Position Matching, and Limb Kinesthesia. These assessments use z-scores, based on normal distributions, as a measure of performance. Scores within 1.96 standard deviations away from 0 are considered normal and scores beyond 1.96 standard deviations are considered impaired.
Time frame: Control participant: baseline; Stroke participant: week 1, week 6, week 12, and week 26
Motor Learning
The average initial path deviations (IPDs) and peak lateral deviations (PLDs) across robotic adaptation trials will be used to measure the speed of learning.
Time frame: Control participant: baseline only; Stroke participant: week 1 and week 26
Arm Reflexes
A measure of bicep, tricep, and brachioradialis reflexes, with scores ranging from 0 (no response) to 4+ (very brisk, hyperactive).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Calgary - Teaching Research and Wellness (TRW) Building
Calgary, Alberta, Canada
RECRUITINGTime frame: Stroke participant only: week 1, week 6, week 12, and week 26
Modified Ashworth Scale (MAS)
A strength scale used to assess muscle tone during flexion and extension. Scores range from 0 (no increase in tone) to 4 (affected part(s) rigid in flexion or extension), with lower scores indicating better function.
Time frame: Stroke participant only: week 1, week 6, week 12, and week 26
Strength
Strength will be assessed using the Medical Research Council scale for muscles in the upper extremity. Scores range from 0 (no muscular contraction detected0 to 5 (normal muscle strength).
Time frame: Stroke participant only: week 1, week 6, week 12, and week 26
Apraxia
An assessment of characteristics of limb-kinetic apraxia. Scores range from 0 to 6, with higher scores indicating better function.
Time frame: Stroke participant only: week 1, week 6, week 12, and week 26
Thumb Localizing Test
A standardized assessment of proprioception. Scores range from 1 (no difficulty) to 3 (severe difficulty), with lower scores indicating better function.
Time frame: Stroke participant only: week 1, week 6, week 12, and week 26
Chedoke-McMaster Stroke Assessment-Impairment Inventory
The Chedoke-McMaster is a screening and assessment tool utilized to measure physical impairment and activity of an individual following a stroke. The 15 items are scored on a 7-point scale (1 through 7, complete dependence to independent, respectively).
Time frame: Stroke participant only: week 1, week 6, week 12, and week 26
Fugl-Meyer Upper Extremity Assessment (FMA)
The FMA is an evaluation of upper extremity motor impairment based on 22 items. Scores range from 0 (completely plegic) to 66 (normal).
Time frame: Stroke participant only: week 1, week 6, week 12, and week 26
Functional Independence Measure (FIM)
The FIM rates individuals on 18 items across areas such as eating, grooming, bathing and dressing on a scale from 1 (total assistance needed) to 7 (complete independence). Lowest possible score is 18 (lowest independence) and the best possible score is 126 (completely independent). The FIM is the standard measure used by rehabilitation facilities in Cananda and the United States to evaluate overall function and burden of care.
Time frame: Stroke participant only: week 1, week 6, week 12, and week 26
Montreal Cognitive Assessment (MoCA)
A cognitive screening test used to assess: short term memory, visuospatial abilities, executive functions, attention, concentration, working memory, language, and orientation to time and place. Higher scores indicate better function.
Time frame: Stroke participant only: week 1, week 6, week 12, and week 26
Magnetic Resonance Imaging (MRI)
Structural images taken after 6-weeks post-stroke. These images will be used to document lesion location and size, and to provide underlying information about functional connections between brain structures.
Time frame: Stroke participant only: week 6
Standard of Care Rehabilitation Therapy
Standard therapy doses will be based on therapist reports and random audits by a member of the study team who will, on two dates unknown to the participant and clinical staff, observe and record the timing and content of an entire therapy session. Observations will be compared to staff reports. This information will be used to verify that therapy is similar for stroke affecting the (non-)dominant arms.
Time frame: Stroke participant only: two days between week 1 and week 26