Motor Learning for Upper Limb Hemiparesis After Stroke
Motor Learning for Individuals With Upper Limb Hemiparesis After Stroke
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Dawn Nilsen, EdD
- Email: dmn12@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Irving Medical Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 6 months following stroke (ischemic or hemorrhagic)
- Upper limb weakness resulting from the stroke
- Able to follow 2-step commands
- Box and Block test score of 3-60
- Intact proprioception at the index finger of the weaker arm
- English speaking
Exclusion Criteria:
- Severe neglect (Score of 2 on extinction and inattention items of NIHSS)
- Arm pain that limits movement or loss of functional range of movement (contracture)
- Unable to give informed consent
- Received Botox within the past 3-months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Training with Practice Variable
All participants will practice a motor task (the Scooping Task) for 2 consecutive days.
Each day of training, participants will complete 50 trials (10 blocks of 5 trials each) with their more affected arm and 20 trials (10 blocks of 2 trials each) with their less affected arm.
One trial of the task will involve using a spoon to scoop beans, one at a time, from one cup to another while seated at a table.
Participants will be asked to complete as many scoops as possible from the cup closest to them to the cup farthest from them within 30 seconds in an anterior-posterior direction.
One successful repetition occurs when at least one bean is transferred.
The number of successful repetitions within a 30 second trial is then counted.
Training for the experimental group will include the practice variable of interest.
|
This group receives the practice variable.
The practice variable being studied will not be disclosed until completion of testing procedures.
|
|
Other: Training without Practice Variable
All participants will practice a motor task (the Scooping Task) for 2 consecutive days.
Each day of training, participants will complete 50 trials (10 blocks of 5 trials each) with their more affected arm and 20 trials (10 blocks of 2 trials each) with their less affected arm.
One trial of the task will involve using a spoon to scoop beans, one at a time, from one cup to another while seated at a table.
Participants will be asked to complete as many scoops as possible from the cup closest to them to the cup farthest from them within 30 seconds in an anterior-posterior direction.
One successful repetition occurs when at least one bean is transferred.
The number of successful repetitions within a 30 second trial is then counted.
Training for the control group will not include the practice variable of interest.
|
This group does not receive the practice variable.
The practice variable being studied will not be disclosed until completion of testing procedures.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
24-Hour Retention Test: Number of completed scoops (more affected arm)
Time Frame: Day 3
|
This is a 24-hour Retention Test of the trained motor task (the Scooping Task) that the participant practiced for 2 days.
The participant is asked to use a spoon to scoop beans from one cup to another in an anterior-posterior direction, away from their body, for 30 seconds.
One completed scoop occurs when at least one bean is transferred to the second cup.
The score is the number of completed scoops that occur within 30 seconds.
The participant will complete two blocks of five trials (30 seconds each).
The number of completed scoops will be averaged across blocks of trials.
|
Day 3
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immediate Transfer Test: Number of transported cubes (more affected arm)
Time Frame: Day 2
|
This is an Immediate Transfer Test that will be administered on Day 2 following completion of training on the Scooping Task.
The participant is asked to transport cubes in an anterior-posterior direction away from their body, using the Box and Block Test apparatus, for 30 seconds.
The score is the number of cubes that are transported within 30 seconds.
The participant will complete two blocks of five trials (30 seconds each).
The number of transported cubes will be averaged across blocks of trials.
|
Day 2
|
|
24-Hour Transfer Test: Number of transported cubes (more affected arm)
Time Frame: Day 3
|
This is a 24-Hour Transfer Test that will be administered on Day 3. The participant is asked to transport cubes in an anterior-posterior direction away from their body, using the Box and Block Test apparatus, for 30 seconds.
The score is the number of cubes that are transported within 30 seconds.
The participant will complete two blocks of five trials (30 seconds each).
The number of transported cubes will be averaged across blocks of trials.
|
Day 3
|
|
Self-Efficacy Rating for Scooping Task
Time Frame: Day 2
|
After completing training on Day 2, the participant will be asked to rate their confidence in achieving various scores on the trained motor task (the Scooping Task).
Self-Efficacy will be rated using a 10 point scale (0 = Not confident at all; 10 = Very confident) with higher scores indicating a better outcomes.
Scores will be calculated by averaging Self-Efficacy ratings.
|
Day 2
|
|
Rating of Mood
Time Frame: Day 2
|
After completing training on Day 2, participants will be asked to rate their mood using the valence subscale of the Self-Assessment Manikin, which is a non-verbal assessment of affect that has five pictures of smiling, neutral, and frowning faces.
The participant rates their mood using a 9 point scale based on the pictures (1 = More positive affect; 9 = Less positive affect) with lower scores indicating a better outcome.
|
Day 2
|
|
Interest/Enjoyment Subscale of the Intrinsic Motivation Inventory
Time Frame: Day 2
|
After completing training on Day 2, the participant will complete items from the interest/enjoyment subscale of the Intrinsic Motivation Inventory.
This is an assessment of participant's subjective experience of the Scooping Task.
Participants will rate each statement according to how true it is for them, using a 7 point scale (1 = Not true at all; 7 = Very true).
Higher scores indicate greater interest/enjoyment when practicing the task (better outcome).
Scores are calculated by averaging the item scores of the subscale.
|
Day 2
|
|
Perceived Competence Subscale of the Intrinsic Motivation Inventory
Time Frame: Day 2
|
After completing training on Day 2, the participant will complete items from the perceived competence subscale of the Intrinsic Motivation Inventory.
This is an assessment of participant's subjective experience of the Scooping Task.
Participants will rate each statement according to how true it is for them, using a 7 point scale (1 = Not true at all; 7 = Very true).
Higher scores indicate greater perceived competence when practicing the task (better outcome).
Scores are calculated by averaging the item scores of the subscale.
|
Day 2
|
|
Perceived Choice Subscale of the Intrinsic Motivation Inventory
Time Frame: Day 2
|
After completing training on Day 2, the participant will complete items from the perceived choice subscale of the Intrinsic Motivation Inventory.
This is an assessment of participant's subjective experience of the Scooping Task.
Participants will rate each statement according to how true it is for them, using a 7 point scale (1 = Not true at all; 7 = Very true).
Higher scores indicate greater perceived choice when practicing the task (better outcome).
Scores are calculated by averaging the item scores of the subscale.
|
Day 2
|
|
Value Subscale of the Intrinsic Motivation Inventory
Time Frame: Day 2
|
After completing training on Day 2, the participant will complete items from the value subscale of the Intrinsic Motivation Inventory.
This is an assessment of participant's subjective experience of the Scooping Task.
Participants will rate each statement according to how true it is for them, using a 7 point scale (1 = Not true at all; 7 = Very true).
Higher scores indicate greater value associated with the task (better outcome).
Scores are calculated by averaging the item scores of the subscale.
|
Day 2
|
|
Effort Subscale of the Intrinsic Motivation Inventory
Time Frame: Day 2
|
After completing training on Day 2, the participant will complete items from the effort subscale of the Intrinsic Motivation Inventory.
This is an assessment of participant's subjective experience of the Scooping Task.
Participants will rate each statement according to how true it is for them, using a 7 point scale (1 = Not true at all; 7 = Very true).
Higher scores indicate greater effort associated with the task (better outcome).
Scores are calculated by averaging the item scores of the subscale.
|
Day 2
|
|
Pressure/Tension Subscale of the Intrinsic Motivation Inventory
Time Frame: Day 2
|
After completing training on Day 2, the participant will complete items from the pressure/tension subscale of the Intrinsic Motivation Inventory.
This is an assessment of participant's subjective experience of the Scooping Task.
Participants will rate each statement according to how true it is for them, using a 7 point scale (1 = Not true at all; 7 = Very true).
Higher scores indicate greater pressure/tension when practicing the task (worse outcome).
Scores are calculated by averaging the item scores of the subscale.
|
Day 2
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
24-Hour Retention Test: Number of completed scoops (less affected arm)
Time Frame: Day 3
|
This is a 24-hour Retention Test of the trained motor task (the Scooping Task) that the participant practiced for 2 days.
The participant is asked to use a spoon to scoop beans from one cup to another in an anterior-posterior direction, away from their body, for 30 seconds.
One completed scoop occurs when at least one bean is transferred to the second cup.
The score is the number of completed scoops that occur within 30 seconds.
The participant will complete two blocks of two trials (30 seconds each).
The number of completed scoops will be averaged across blocks of trials.
|
Day 3
|
|
Immediate Transfer Test: Number of transported cubes (less affected arm)
Time Frame: Day 2
|
This is an Immediate Transfer Test that will be administered on Day 2 following completion of training on the Scooping Task.
The participant is asked to transport cubes in an anterior-posterior direction away from their body, using the Box and Block Test apparatus, for 30 seconds.
The score is the number of cubes that are transported within 30 seconds.
The participant will complete two blocks of two trials (30 seconds each).
The number of transported cubes will be averaged across blocks of trials.
|
Day 2
|
|
24-Hour Transfer Test: Number of transported cubes (less affected arm)
Time Frame: Day 3
|
This is a 24-Hour Transfer Test that will be administered on Day 3. The participant is asked to transport cubes in an anterior-posterior direction away from their body, using the Box and Block Test apparatus, for 30 seconds.
The score is the number of cubes that are transported within 30 seconds.
The participant will complete two blocks of two trials (30 seconds each).
The number of transported cubes will be averaged across blocks of trials.
|
Day 3
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Dawn Nilsen, EdD, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- AAAU1704
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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