Robotic Evaluations of Motor Learning During Stroke Neurorehabilitation
- Conditions
- Stroke
- Interventions
- Other: Magnetic Resonance Imaging (MRI)Other: Clinical AssessmentDevice: Kinarm Robotic Exoskeleton Assessment
- Registration Number
- NCT05106140
- Lead Sponsor
- University of Calgary
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control Participants Clinical Assessment This group will include healthy individuals from the community who are matched for age and sex to stroke participants. Stroke Participants Kinarm Robotic Exoskeleton Assessment This group will include stroke survivors from the Calgary Stroke Program who are over 18 years of age. Control Participants Kinarm Robotic Exoskeleton Assessment This group will include healthy individuals from the community who are matched for age and sex to stroke participants. Stroke Participants Magnetic Resonance Imaging (MRI) This group will include stroke survivors from the Calgary Stroke Program who are over 18 years of age. Stroke Participants Clinical Assessment This group will include stroke survivors from the Calgary Stroke Program who are over 18 years of age.
- Primary Outcome Measures
Name Time Method Changes in Path Deviations Control participant: baseline only; Stroke participant: week 1 and week 26 Initial path deviations (IPDs) will be measured during each robotic task movement and used to measure learning in each session.
Peak Lateral Deviations Stroke participant: week 26 Peak lateral deviations (PLDs) will be measured during each robotic task movement and used to measure learning in each session.
- Secondary Outcome Measures
Name Time Method Thumb Localizing Test Stroke participant only: week 1, week 6, week 12, and week 26 A standardized assessment of proprioception. Scores range from 1 (no difficulty) to 3 (severe difficulty), with lower scores indicating better function.
Robotic Assessment Control participant: baseline; Stroke participant: week 1, week 6, week 12, and week 26 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.
Apraxia Stroke participant only: week 1, week 6, week 12, and week 26 An assessment of characteristics of limb-kinetic apraxia. Scores range from 0 to 6, with higher scores indicating better function.
Magnetic Resonance Imaging (MRI) Stroke participant only: week 6 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.
Chedoke-McMaster Stroke Assessment-Impairment Inventory Stroke participant only: week 1, week 6, week 12, and week 26 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).
Arm Reflexes Stroke participant only: week 1, week 6, week 12, and week 26 A measure of bicep, tricep, and brachioradialis reflexes, with scores ranging from 0 (no response) to 4+ (very brisk, hyperactive).
Modified Ashworth Scale (MAS) Stroke participant only: week 1, week 6, week 12, and week 26 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.
Strength Stroke participant only: week 1, week 6, week 12, and week 26 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).
Fugl-Meyer Upper Extremity Assessment (FMA) Stroke participant only: week 1, week 6, week 12, and week 26 The FMA is an evaluation of upper extremity motor impairment based on 22 items. Scores range from 0 (completely plegic) to 66 (normal).
Functional Independence Measure (FIM) Stroke participant only: week 1, week 6, week 12, and week 26 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.
Motor Learning Control participant: baseline only; Stroke participant: week 1 and week 26 The average initial path deviations (IPDs) and peak lateral deviations (PLDs) across robotic adaptation trials will be used to measure the speed of learning.
Montreal Cognitive Assessment (MoCA) Stroke participant only: week 1, week 6, week 12, and week 26 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.
Standard of Care Rehabilitation Therapy Stroke participant only: two days between week 1 and week 26 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.
Trial Locations
- Locations (4)
Carewest Dr. Vernon Fanning Centre
🇨🇦Calgary, Alberta, Canada
University of Calgary - Kinesiology Building
🇨🇦Calgary, Alberta, Canada
Foothills Hospital - Main Building
🇨🇦Calgary, Alberta, Canada
University of Calgary - Teaching Research and Wellness (TRW) Building
🇨🇦Calgary, Alberta, Canada