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Motor Learning for Upper Limb Hemiparesis After Stroke

Primary Purpose

Stroke, Hemiparesis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Practice Variable
No Practice Variable
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring Stroke, Hemiparesis, Rehabilitation, Motor Learning

Eligibility Criteria

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

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 Currently participating in upper limb therapy Received Botox within the past 3-months

Sites / Locations

  • Columbia University Irving Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Training with Practice Variable

Training without Practice Variable

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

24-Hour Retention Test: Number of completed scoops (more affected arm)
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.

Secondary Outcome Measures

Immediate Transfer Test: Number of transported cubes (more affected arm)
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.
24-Hour Transfer Test: Number of transported cubes (more affected arm)
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.
Self-Efficacy Rating for Scooping Task
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.
Rating of Mood
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.
Interest/Enjoyment Subscale of the Intrinsic Motivation Inventory
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.
Perceived Competence Subscale of the Intrinsic Motivation Inventory
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.
Perceived Choice Subscale of the Intrinsic Motivation Inventory
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.
Value Subscale of the Intrinsic Motivation Inventory
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.
Effort Subscale of the Intrinsic Motivation Inventory
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.
Pressure/Tension Subscale of the Intrinsic Motivation Inventory
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.

Full Information

First Posted
March 1, 2023
Last Updated
March 1, 2023
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT05765474
Brief Title
Motor Learning for Upper Limb Hemiparesis After Stroke
Official Title
Motor Learning for Individuals With Upper Limb Hemiparesis After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this research is to learn about practice conditions that may benefit stroke survivors when learning to use their more affected arm to perform a task. Participants will be randomized into two groups. Experimental and control groups will differ by one practice variable that will not be disclosed until completion of testing procedures. Participants will practice a motor task using both their more and less affected arms for two consecutive days. A Pre-Test will be administered on Day 1 before the training begins. Immediate Transfer of Learning will be administered on Day 2 after the completion of training. Delayed (24-hour) Retention and Transfer Tests will be administered on Day 3.
Detailed Description
Stroke involves loss of blood flow to the brain and can cause impaired upper limb motor function, resulting in long term disability. Targeted motor learning interventions can improve skill acquisition and functional upper limb use after stroke. For example, repetitive practice of a motor task has been shown to improve motor learning outcomes. However, more research is currently needed to identify important active ingredients in complex motor learning interventions and determine the most effective approaches for improving upper limb recovery after stroke. The purpose of this study is to investigate the impact of a specific practice variable on motor learning for individuals with upper limb hemiparesis after stroke. This research will inform the development of future stroke rehabilitation interventions aimed at improving skill acquisition and motor learning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
Stroke, Hemiparesis, Rehabilitation, Motor Learning

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Research participants will be blinded to the overall purpose of the study and will not be informed of the difference between the groups. They will be debriefed after the completion of all study procedures in accordance with IRB policies. Outcomes assessors will be blinded to group allocation.
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training with Practice Variable
Arm Type
Experimental
Arm Description
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.
Arm Title
Training without Practice Variable
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Practice Variable
Intervention Description
This group receives the practice variable. The practice variable being studied will not be disclosed until completion of testing procedures.
Intervention Type
Behavioral
Intervention Name(s)
No Practice Variable
Intervention Description
This group does not receive the practice variable. The practice variable being studied will not be disclosed until completion of testing procedures.
Primary Outcome Measure Information:
Title
24-Hour Retention Test: Number of completed scoops (more affected arm)
Description
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.
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Immediate Transfer Test: Number of transported cubes (more affected arm)
Description
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.
Time Frame
Day 2
Title
24-Hour Transfer Test: Number of transported cubes (more affected arm)
Description
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.
Time Frame
Day 3
Title
Self-Efficacy Rating for Scooping Task
Description
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.
Time Frame
Day 2
Title
Rating of Mood
Description
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.
Time Frame
Day 2
Title
Interest/Enjoyment Subscale of the Intrinsic Motivation Inventory
Description
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.
Time Frame
Day 2
Title
Perceived Competence Subscale of the Intrinsic Motivation Inventory
Description
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.
Time Frame
Day 2
Title
Perceived Choice Subscale of the Intrinsic Motivation Inventory
Description
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.
Time Frame
Day 2
Title
Value Subscale of the Intrinsic Motivation Inventory
Description
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.
Time Frame
Day 2
Title
Effort Subscale of the Intrinsic Motivation Inventory
Description
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.
Time Frame
Day 2
Title
Pressure/Tension Subscale of the Intrinsic Motivation Inventory
Description
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.
Time Frame
Day 2
Other Pre-specified Outcome Measures:
Title
24-Hour Retention Test: Number of completed scoops (less affected arm)
Description
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.
Time Frame
Day 3
Title
Immediate Transfer Test: Number of transported cubes (less affected arm)
Description
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.
Time Frame
Day 2
Title
24-Hour Transfer Test: Number of transported cubes (less affected arm)
Description
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.
Time Frame
Day 3

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: 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 Currently participating in upper limb therapy Received Botox within the past 3-months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Winterbottom, MS
Phone
212-305-6722
Email
lbw2136@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dawn Nilsen, EdD
Email
dmn12@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Nilsen, EdD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Winterbottom, MS
Phone
212-305-6722
Email
lbw2136@cumc.columbia.edu

12. IPD Sharing Statement

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Motor Learning for Upper Limb Hemiparesis After Stroke

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