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Robotic Evaluations of Motor Learning During Stroke Neurorehabilitation (RELEARN)

2. november 2021 oppdatert av: University of Calgary
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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2E 6V7
        • Rekruttering
        • Carewest Dr. Vernon Fanning Centre
        • Ta kontakt med:
      • Calgary, Alberta, Canada, T2N 1N4
        • Rekruttering
        • University of Calgary - Kinesiology Building
        • Ta kontakt med:
      • Calgary, Alberta, Canada, T2N2T9
        • Rekruttering
        • Foothills Hospital - Main Building
        • Ta kontakt med:
      • Calgary, Alberta, Canada, T2N2T9
        • Rekruttering
        • University of Calgary - Teaching Research and Wellness (TRW) Building
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Stroke Participants
This group will include stroke survivors from the Calgary Stroke Program who are over 18 years of age.
Annen: Magnetic Resonance Imaging (MRI)
A research MRI will be performed at 6-weeks post-stroke to document stroke lesion location and size.
Enhet: 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.

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

Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in Path Deviations
Tidsramme: 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.
Control participant: baseline only; Stroke participant: week 1 and week 26
Peak Lateral Deviations
Tidsramme: 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.
Control participant: baseline only; Stroke participant: week 1
Peak Lateral Deviations
Tidsramme: Stroke participant: week 26
Peak lateral deviations (PLDs) will be measured during each robotic task movement and used to measure learning in each session.
Stroke participant: week 26

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Robotic Assessment
Tidsramme: 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.
Control participant: baseline; Stroke participant: week 1, week 6, week 12, and week 26
Motor Learning
Tidsramme: 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.
Control participant: baseline only; Stroke participant: week 1 and week 26
Arm Reflexes
Tidsramme: 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).
Stroke participant only: week 1, week 6, week 12, and week 26
Modified Ashworth Scale (MAS)
Tidsramme: 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.
Stroke participant only: week 1, week 6, week 12, and week 26
Strength
Tidsramme: 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).
Stroke participant only: week 1, week 6, week 12, and week 26
Apraxia
Tidsramme: 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.
Stroke participant only: week 1, week 6, week 12, and week 26
Thumb Localizing Test
Tidsramme: 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.
Stroke participant only: week 1, week 6, week 12, and week 26
Chedoke-McMaster Stroke Assessment-Impairment Inventory
Tidsramme: 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).
Stroke participant only: week 1, week 6, week 12, and week 26
Fugl-Meyer Upper Extremity Assessment (FMA)
Tidsramme: 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).
Stroke participant only: week 1, week 6, week 12, and week 26
Functional Independence Measure (FIM)
Tidsramme: 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.
Stroke participant only: week 1, week 6, week 12, and week 26
Montreal Cognitive Assessment (MoCA)
Tidsramme: 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.
Stroke participant only: week 1, week 6, week 12, and week 26
Magnetic Resonance Imaging (MRI)
Tidsramme: 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.
Stroke participant only: week 6
Standard of Care Rehabilitation Therapy
Tidsramme: 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.
Stroke participant only: two days between week 1 and week 26

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Calgary

Samarbeidspartnere

Canadian Institutes of Health Research (CIHR)

Etterforskere

  • Hovedetterforsker: Sean Dukelow, MD PhD FRCPC, University of Calgary, Calgary, Alberta, Canada
  • Hovedetterforsker: Tyler Cluff, PhD, University of Calgary, Calgary, Alberta, Canada

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. september 2021

Primær fullføring (Forventet)

1. september 2026

Studiet fullført (Forventet)

1. september 2026

Datoer for studieregistrering

Først innsendt

31. mai 2021

Først innsendt som oppfylte QC-kriteriene

2. november 2021

Først lagt ut (Faktiske)

3. november 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2021

Sist bekreftet

1. juli 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • REB21-0441

Plan for individuelle deltakerdata (IPD)

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NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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