StrokeNCT05765474
Motor Learning for Upper Limb Hemiparesis After Stroke
A study testing Practice Variable and No Practice Variable in people with Stroke and Hemiparesis, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Practice Variable and No Practice Variable
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2023to 16 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Motor Learning for Individuals With Upper Limb Hemiparesis After Stroke
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.
Read the 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.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Practice Variable, No Practice Variable
- Keywords
- Stroke, Hemiparesis, Rehabilitation, Motor Learning
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice VariableBehavioural
This group receives the practice variable. The practice variable being studied will not be disclosed until completion of testing procedures.
No Practice VariableBehavioural
This group does not receive the practice variable. The practice variable being studied will not be disclosed until completion of testing procedures.
| Study group | Role | What they receive |
|---|---|---|
| Training with Practice Variable | Experimental | 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. Receives: Behavioral: Practice Variable |
| Training without Practice Variable | Other | 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. Receives: Behavioral: No Practice Variable |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 3
Secondary outcomes (10)
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.
Measured: Day 2
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.
Measured: Day 3
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.
Measured: Day 2
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.
Measured: Day 2
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.
Measured: Day 2
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.
Measured: Day 2
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.
Measured: Day 2
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.
Measured: Day 2
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.
Measured: Day 2
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.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start22 Mar 2023
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn Nilsen, Columbia University
- Investigators
- Dawn Nilsen, EdD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765474
- Sponsor's protocol ID
- AAAU1704
- Status last verified
- Aug 2025
- First submitted
- 1 Mar 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Learning for Individuals With Upper Limb Hemiparesis After Stroke
- ClinicalTrials.gov ID
- NCT05765474
- Acronym / sponsor ID
- AAAU1704
- Conditions
- Stroke, Hemiparesis
- Keywords
- Stroke, Hemiparesis, Rehabilitation, Motor Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training with Practice Variable | Experimental | Behavioral: Practice VariableAll 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. |
| Training without Practice Variable | Other | Behavioral: No Practice VariableAll 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Practice VariableThis group receives the practice variable. The practice variable being studied will not be disclosed until completion of testing procedures. | Behavioural | Training with Practice Variable |
| No Practice VariableThis group does not receive the practice variable. The practice variable being studied will not be disclosed until completion of testing procedures. | Behavioural | Training without Practice Variable |
Primary outcome
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.
10 secondary outcomes
Immediate Transfer Test: Number of transported cubes (more affected arm)
Time frame: Day 2
24-Hour Transfer Test: Number of transported cubes (more affected arm)
Time frame: Day 3
Self-Efficacy Rating for Scooping Task
Time frame: Day 2
Rating of Mood
Time frame: Day 2
Interest/Enjoyment Subscale of the Intrinsic Motivation Inventory
Time frame: Day 2
Perceived Competence Subscale of the Intrinsic Motivation Inventory
Time frame: Day 2
Perceived Choice Subscale of the Intrinsic Motivation Inventory
Time frame: Day 2
Value Subscale of the Intrinsic Motivation Inventory
Time frame: Day 2
Effort Subscale of the Intrinsic Motivation Inventory
Time frame: Day 2
Pressure/Tension Subscale of the Intrinsic Motivation Inventory
Time frame: Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
Related trials for Stroke
Not yet recruiting
Cardiac CT Angiography in Acute Stroke Imaging (SCOPE-CT)
Acute Ischemic Stroke and Transient Ischemic Attacks
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
Recruiting
Music Therapy in Post-Stroke Patients: A Clinical Trial
CVA (Cerebrovascular Accident), Ictus
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Nilsen, EdD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice Variable and No Practice Variable in people with Stroke and Hemiparesis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-Hour Retention Test: Number of completed scoops (more affected arm) (time frame: Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.