Motor Learning for Upper Limb Hemiparesis After Stroke

Stroke Clinical Trial

Official title:

Motor Learning for Individuals With Upper Limb Hemiparesis After Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05765474
• Other study ID #: AAAU1704
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: August 1, 2024
• Est. primary completion date: February 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

Behavioral:
• Practice Variable
This group receives the practice variable. The practice variable being studied will not be disclosed until completion of testing procedures.
• No Practice Variable
This group does not receive the practice variable. The practice variable being studied will not be disclosed until completion of testing procedures.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 3
Secondary	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.	Day 2
Secondary	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.	Day 3
Secondary	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.	Day 2
Secondary	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.	Day 2
Secondary	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.	Day 2
Secondary	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.	Day 2
Secondary	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.	Day 2
Secondary	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.	Day 2
Secondary	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.	Day 2
Secondary	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.	Day 2