NCT05765474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

March 22, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2024

Completed
Last Updated

September 12, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

March 1, 2023

Last Update Submit

September 8, 2025

Conditions

Keywords

StrokeHemiparesisRehabilitationMotor Learning

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Immediate Transfer Test: Number of transported cubes (more affected arm)

    Day 2

  • 24-Hour Transfer Test: Number of transported cubes (more affected arm)

    Day 3

  • Self-Efficacy Rating for Scooping Task

    Day 2

  • Rating of Mood

    Day 2

  • Interest/Enjoyment Subscale of the Intrinsic Motivation Inventory

    Day 2

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: No Practice Variable

Interventions

This group receives the practice variable. The practice variable being studied will not be disclosed until completion of testing procedures.

Training with Practice Variable

This group does not receive the practice variable. The practice variable being studied will not be disclosed until completion of testing procedures.

Training without Practice Variable

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dawn Nilsen, EdD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Rehabilitation and Regenerative Medicine

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 13, 2023

Study Start

March 22, 2023

Primary Completion

February 16, 2024

Study Completion

February 16, 2024

Last Updated

September 12, 2025

Record last verified: 2025-08

Locations