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Robotic Evaluations of Motor Learning During Stroke Neurorehabilitation (RELEARN)

2021年11月2日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (予想される)

300

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • カナダ
    • Alberta
      • Calgary、Alberta、カナダ、T2E 6V7
        • 募集
        • Carewest Dr. Vernon Fanning Centre
        • コンタクト：
      • Calgary、Alberta、カナダ、T2N 1N4
        • 募集
        • University of Calgary - Kinesiology Building
        • コンタクト：
      • Calgary、Alberta、カナダ、T2N2T9
        • 募集
        • Foothills Hospital - Main Building
        • コンタクト：
      • Calgary、Alberta、カナダ、T2N2T9
        • 募集
        • University of Calgary - Teaching Research and Wellness (TRW) Building
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Stroke Participants
This group will include stroke survivors from the Calgary Stroke Program who are over 18 years of age.
他の：Magnetic Resonance Imaging (MRI)
A research MRI will be performed at 6-weeks post-stroke to document stroke lesion location and size.
デバイス：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.

他の：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.
デバイス：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.

他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Changes in Path Deviations
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Robotic Assessment
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Calgary

協力者

Canadian Institutes of Health Research (CIHR)

捜査官

  • 主任研究者：Sean Dukelow, MD PhD FRCPC、University of Calgary, Calgary, Alberta, Canada
  • 主任研究者：Tyler Cluff, PhD、University of Calgary, Calgary, Alberta, Canada

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年9月20日

一次修了 (予想される)

2026年9月1日

研究の完了 (予想される)

2026年9月1日

試験登録日

最初に提出

2021年5月31日

QC基準を満たした最初の提出物

2021年11月2日

最初の投稿 (実際)

2021年11月3日

学習記録の更新

投稿された最後の更新 (実際)

2021年11月3日

QC基準を満たした最後の更新が送信されました

2021年11月2日

最終確認日

2021年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • REB21-0441

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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