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
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
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
NCT ID
NCT05268861
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
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
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The Role of Cognition in Motor Learning After Stroke
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