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The Role of Cognition in Motor Learning After Stroke

Primary Purpose

Stroke Hemorrhagic, Stroke, Ischemic, Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Error Augmentation Feedback
No Error Augmentation Feedback
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Hemorrhagic focused on measuring virtual reality, motor learning, cognition, intrinsic feedback, cognitive impairment, imaging, error augmentation

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Sustained a first cortical/sub-cortical ischemic/hemorrhagic stroke less than 3 years previously and are medically stable.
  • Are no longer receiving treatment.
  • Normal or corrected-to-normal vision.
  • Have arm paresis (Chedoke-McMaster Arm Scale 2-6/7) and spasticity (Modified Ashworth Scale ≥ 1/4) but can voluntarily flex/extend the elbow to approximately 30 degrees in each direction.

Exclusion Criteria:

  • Other major neurological or musculoskeletal problems that may interfere with task performance.
  • Marked elbow proprioceptive deficits (<6/12 Fugl-Meyer UL sensation scale) that may interfere with elbow position perception.
  • Visuospatial neglect (Line Bisection Test deviation > 6 mm).
  • Uncorrected vision.
  • Depression (≥ 14 Beck Depression Inventory II).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Training with EA feedback

    Training without EA feedback

    Arm Description

    Subjects will undergo training with the EA-VR game that includes a 15 degree elbow flexion error.

    Subjects will undergo training with the EA-VR game that does not include EA feedback.

    Outcomes

    Primary Outcome Measures

    Change in endpoint error
    The distance between the endpoint marker and the target at the end of a reaching movement.
    Change in movement time
    The time between the onset and offset of the movement.
    Change in path straightness
    Described using the index of curvature where the ratio between the actual movement path is compared to a straight line.
    Change in path smoothness
    The number of peaks on a tangential velocity trace for each reaching trial.
    Change in range of active elbow extension
    Determined by the tonic stretch reflex threshold (TSRT) -- the angle at which muscles begin to get recruited for movement at zero velocity.
    Change in size of active arm workspace area
    The size of the active arm workspace area will be expressed as a ratio of the active workspace determined when the subject actively moves their arm through the horizontal workspace to the passive workspace that is defined by the examiner moving the arm through the same space.

    Secondary Outcome Measures

    Correlation of the index of performance with the degree of cognitive and motor impairment, severity of damage to cortical areas, and white matter integrity.
    The investigators will correlate the index of performance (IP), a measure of reaching accuracy, with deficits in perception and executive function that will be assessed with clinical motor impairment and activity evaluations, and the severity of damage to cortical areas and white matter integrity.

    Full Information

    First Posted
    December 29, 2021
    Last Updated
    February 24, 2022
    Sponsor
    McGill University
    Collaborators
    Canadian Institutes of Health Research (CIHR), Montreal Neurological Institute and Hospital, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05268861
    Brief Title
    The Role of Cognition in Motor Learning After Stroke
    Official Title
    The Role of Cognition in the Use of Enhanced Intrinsic Feedback for Motor Learning After Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2022 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    McGill University
    Collaborators
    Canadian Institutes of Health Research (CIHR), Montreal Neurological Institute and Hospital, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Stroke leads to lasting problems in using the upper limb (UL) for everyday life activities. While rehabilitation programs depend on motor learning, UL recovery is less than ideal. Implicit learning is thought to lead to better outcomes than explicit learning. Cognitive factors (e.g., memory, attention, perception), essential to implicit motor learning, are often impaired in people with stroke. The objective of this study is to investigate the role of cognitive deficits on implicit motor learning in people with stroke. The investigators hypothesize that 1) subjects with stroke will achieve better motor learning when training with additional intrinsic feedback compared to those who train without additional intrinsic feedback, and 2) individuals with stroke who have cognitive deficits will have impairments in their ability to use feedback to learn a motor skill compared to individuals with stroke who do not have cognitive deficits. A recent feedback modality, called error augmentation (EA), can be used to enhance motor learning by providing subjects with magnified motor errors that the nervous system can use to adapt performance. The investigators will use a custom-made training program that includes EA feedback in a virtual reality (VR) environment in which the range of the UL movement is related to the patient's specific deficit in the production of active elbow extension. An avatar depiction of the arm will include a 15 deg elbow flexion error to encourage subjects to increase elbow extension beyond the current limitations. Thus, the subject will receive feedback that the elbow has extended less than it actually has and will compensate by extending the elbow further. Subjects will train for 30 minutes with the EA program 3 times a week for 9 weeks. Kinematic and clinical measures will be recorded before, after 3 weeks, after 6 weeks, and after 9 weeks. Four weeks after the end of training, there will be a follow-up evaluation. Imaging scans will be done to determine lesion size and extent, and descending tract integrity with diffusion tensor imaging (DTI). This study will identify if subjects with cognitive deficits benefit from individualized training programs using enhanced intrinsic feedback. The development of treatments based on mechanisms of motor learning can move rehabilitation therapy in a promising direction by allowing therapists to design more effective interventions for people with problems using their upper limb following a stroke.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke Hemorrhagic, Stroke, Ischemic, Cognitive Impairment
    Keywords
    virtual reality, motor learning, cognition, intrinsic feedback, cognitive impairment, imaging, error augmentation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Training with EA feedback
    Arm Type
    Experimental
    Arm Description
    Subjects will undergo training with the EA-VR game that includes a 15 degree elbow flexion error.
    Arm Title
    Training without EA feedback
    Arm Type
    Sham Comparator
    Arm Description
    Subjects will undergo training with the EA-VR game that does not include EA feedback.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Error Augmentation Feedback
    Intervention Description
    Error augmentation (EA) is a feedback modality that provides subjects with magnified motor errors. In our intervention, subjects are provided with an elbow angle error that will encourage subjects to use more elbow extension during reaching. Thus, subjects are provided with feedback that their elbow has extended less than it actually has and will compensate by extending the elbow further to successfully reach a target. Subjects will receive an elbow flexion error of 15 degrees to encourage elbow extension.
    Intervention Type
    Behavioral
    Intervention Name(s)
    No Error Augmentation Feedback
    Intervention Description
    Error augmentation (EA) is a feedback modality that provides subjects with magnified motor errors. In our intervention, subjects are provided with an elbow angle error that will encourage subjects to use more elbow extension during reaching. Thus, subjects are provided with feedback that their elbow has extended less than it actually has and will compensate by extending the elbow further to successfully reach a target. In this case, subjects that do not receive EA feedback will act as sham comparators.
    Primary Outcome Measure Information:
    Title
    Change in endpoint error
    Description
    The distance between the endpoint marker and the target at the end of a reaching movement.
    Time Frame
    Change in endpoint error is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in endpoint error is assessed again 4 weeks after the completion of training.
    Title
    Change in movement time
    Description
    The time between the onset and offset of the movement.
    Time Frame
    Change in movement time is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in movement time is assessed again 4 weeks after the completion of training
    Title
    Change in path straightness
    Description
    Described using the index of curvature where the ratio between the actual movement path is compared to a straight line.
    Time Frame
    Change in path straightness is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in path straightness is assessed again 4 weeks after the completion of training.
    Title
    Change in path smoothness
    Description
    The number of peaks on a tangential velocity trace for each reaching trial.
    Time Frame
    Change in path straightness is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in path smoothness is assessed again 4 weeks after the completion of training.
    Title
    Change in range of active elbow extension
    Description
    Determined by the tonic stretch reflex threshold (TSRT) -- the angle at which muscles begin to get recruited for movement at zero velocity.
    Time Frame
    The change in the range of active elbow extension is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in the range of active elbow extension is assessed again 4 weeks after the completion of training.
    Title
    Change in size of active arm workspace area
    Description
    The size of the active arm workspace area will be expressed as a ratio of the active workspace determined when the subject actively moves their arm through the horizontal workspace to the passive workspace that is defined by the examiner moving the arm through the same space.
    Time Frame
    The change in the size of the active arm workspace area is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in the size of the active arm workspace is assessed again 4 weeks after training.
    Secondary Outcome Measure Information:
    Title
    Correlation of the index of performance with the degree of cognitive and motor impairment, severity of damage to cortical areas, and white matter integrity.
    Description
    The investigators will correlate the index of performance (IP), a measure of reaching accuracy, with deficits in perception and executive function that will be assessed with clinical motor impairment and activity evaluations, and the severity of damage to cortical areas and white matter integrity.
    Time Frame
    Brain scans will be done prior to the start of training. Cognitive assessments and evaluations of motor impairment and activity are done prior to the start of training, after 3, after 6, after 9, and 4 weeks after the completion of training.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sustained a first cortical/sub-cortical ischemic/hemorrhagic stroke less than 3 years previously and are medically stable. Are no longer receiving treatment. Normal or corrected-to-normal vision. Have arm paresis (Chedoke-McMaster Arm Scale 2-6/7) and spasticity (Modified Ashworth Scale ≥ 1/4) but can voluntarily flex/extend the elbow to approximately 30 degrees in each direction. Exclusion Criteria: Other major neurological or musculoskeletal problems that may interfere with task performance. Marked elbow proprioceptive deficits (<6/12 Fugl-Meyer UL sensation scale) that may interfere with elbow position perception. Visuospatial neglect (Line Bisection Test deviation > 6 mm). Uncorrected vision. Depression (≥ 14 Beck Depression Inventory II).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mindy Levin, PhD, PT
    Phone
    (450) 688-9550
    Ext
    84300
    Email
    mindy.levin@mcgill.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Caroline Rajda, BSc
    Phone
    (450) 688-9550
    Ext
    84655
    Email
    caroline.rajda@mail.mcgill.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mindy Levin, PhD, PT
    Organizational Affiliation
    McGill University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Yes

    Learn more about this trial

    The Role of Cognition in Motor Learning After Stroke

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