StrokeRELEARNNCT05106140
Robotic Evaluations of Motor Learning During Stroke Neurorehabilitation
An observational study of Stroke, run by University of Calgary at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Magnetic Resonance Imaging (MRI), Kinarm Robotic Exoskeleton Assessment and Clinical Assessment
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 4 sitesCanada
- Study dates
- 20 Sep 2021to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
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- Able to follow 3-step task commands
- >18 years old
- Good health
Who cannot join
- 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)
Show all 10Show fewer
- 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
- Significant upper limb neurologic or orthopedic conditions
Trial locations and contacts
4 sites in 1 country.
Canada4 sites, 4 recruiting
- Recruiting
Carewest Dr. Vernon Fanning Centre
Calgary, Alberta, T2E 6V7
Sean Dukelow, MD PhD FRCPC, 403-944-4050, robotlab@ucalgary.ca
- Recruiting
University of Calgary - Kinesiology Building
Calgary, Alberta, T2N 1N4
Tyler Cluff, PhD, 403-220-2840, tyler.cluff@ucalgary.ca
- Recruiting
Foothills Hospital - Main Building
Calgary, Alberta, T2N2T9
Sean Dukelow, MD PhD FRCPC, 403-944-4050, robotlab@ucalgary.ca
- Recruiting
University of Calgary - Teaching Research and Wellness (TRW) Building
Calgary, Alberta, T2N2T9
Sean Dukelow, MD PhD FRCPC, 403-944-4050, robotlab@ucalgary.ca
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Magnetic Resonance Imaging (MRI), Kinarm Robotic Exoskeleton Assessment, Clinical Assessment
- Keywords
- Rehabilitation, Neuroimaging, Motor Learning, Early Stroke Recovery, Neuroplasticity, Limb Dominance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Other
A research MRI will be performed at 6-weeks post-stroke to document stroke lesion location and size.
Kinarm Robotic Exoskeleton AssessmentDevice
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.
Clinical AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Participants | This group will include stroke survivors from the Calgary Stroke Program who are over 18 years of age. Receives: Other: Magnetic Resonance Imaging (MRI); Device: Kinarm Robotic Exoskeleton Assessment; Other: Clinical Assessment | |
| Control Participants | This group will include healthy individuals from the community who are matched for age and sex to stroke participants. Receives: Device: Kinarm Robotic Exoskeleton Assessment; Other: Clinical Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Path Deviations
Initial path deviations (IPDs) will be measured during each robotic task movement and used to measure learning in each session.
Measured: 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.
Measured: 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.
Measured: Stroke participant: week 26
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Stroke participant only: two days between week 1 and week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start20 Sep 2021
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Tyler Cluff, PhD, Principal investigator, University of CalgarySean Dukelow, MD PhD FRCPC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106140
- Sponsor's protocol ID
- REB21-0441
- Acronym
- RELEARN
- Status last verified
- Jul 2021
- First submitted
- 31 May 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Evaluations of Motor Learning During Stroke Neurorehabilitation
- ClinicalTrials.gov ID
- NCT05106140
- Acronym / sponsor ID
- RELEARN / REB21-0441
- Conditions
- Stroke
- Keywords
- Rehabilitation, Neuroimaging, Motor Learning, Early Stroke Recovery, Neuroplasticity, Limb Dominance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke Participants | – | Other: Magnetic Resonance Imaging (MRI), Device: Kinarm Robotic Exoskeleton Assessment, Other: Clinical AssessmentThis group will include stroke survivors from the Calgary Stroke Program who are over 18 years of age. |
| Control Participants | – | Device: Kinarm Robotic Exoskeleton Assessment, Other: Clinical AssessmentThis group will include healthy individuals from the community who are matched for age and sex to stroke participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- History of:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)A research MRI will be performed at 6-weeks post-stroke to document stroke lesion location and size. | Other | Stroke Participants |
| Kinarm Robotic Exoskeleton AssessmentThe 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. | Device | Control Participants, Stroke Participants |
| Clinical AssessmentThe 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. | Other | Control Participants, Stroke Participants |
Primary outcome
Changes in Path Deviations
Time frame: 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
Time frame: Control participant: baseline only; Stroke participant: week 1
Peak lateral deviations (PLDs) will be measured during each robotic task movement and used to measure learning in each session.
Peak Lateral Deviations
Time frame: Stroke participant: week 26
Peak lateral deviations (PLDs) will be measured during each robotic task movement and used to measure learning in each session.
13 secondary outcomes
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
Standard of Care Rehabilitation Therapy
Time frame: Stroke participant only: two days between week 1 and week 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler Cluff, PhD principal investigator
University of Calgary
Sean Dukelow, MD PhD FRCPC principal investigator
University of Calgary
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Calgary at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Stone, BA (403-944-4050, rnstone@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Path Deviations (time frame: Control participant: baseline only; Stroke participant: week 1 and week 26). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.