Exercise and Motor Learning After Stroke (Study #3)

Feedback and Cognition During Locomotor Learning Post Stroke

Subjects with chronic stroke (> 6 months post-stroke) will learn a new walking pattern through distorted visual feedback. Retention of the pattern will be tested without visual feedback immediately after learning and 24 hours later. Subjects will be randomly assigned to the control group or the exercise group. The control group will simply complete the learning task. The exercise group will complete 5 minutes of exercise immediately following the first retention test to test for the effects of exercise on retention 24 hours later.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Exercise

Detailed Description

Despite significant time and money spent on post-stroke rehabilitation, stroke survivors are left with reduced walking capacity and significant disability. After stroke, individuals must relearn movements that have been disrupted due to damage to the brain, therefore, enhancing motor learning is critical to improving the rehabilitation of walking after stroke. In this project investigators will examine how individual factors influence motor learning after stroke and use this information to personalize post-stroke rehabilitation.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Darcy Reisman, PhD; Phone Number: 3028310508; Email: dreisman@udel.edu

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • Recruiting
      • University of Delaware
      • Contact: Darcy Reisman, PhD; Phone Number: 302-831-0508; Email: dreisman@udel.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age 18-85 Single, unilateral, chronic stroke (>6 months post-stroke), confirmed by MRI or CT scan Score >1 on question 1b and >0 on question 1c of the NIH Stroke Scale Able to walk at self-selected speed without assistance from another person Resting heart rate between 40-100 beats per minute Resting blood pressure between 90/60 to 185/100

Exclusion Criteria:

Evidence of cerebellar stroke on clinical MRI or CT scan, because of role of cerebellum in learning Other neurologic conditions in addition to stroke Inability to walk outside the home prior to the stroke Coronary artery bypass graft or myocardial infarction within past 3 months, Musculoskeletal pain that limits walking Inability to communicate with investigators Visual field cut Neglect Unexplained dizziness in last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Subjects will complete learning of a new walking pattern through distorted visual feedback and retention will be tested immediately after and 24 hours later (without visual feedback).
Experimental: Exercise; Subjects will complete learning of a new walking pattern through distorted visual feedback and retention will be tested immediately without visual feedback. This will be followed immediately by 5 minutes of high intensity exercise. Retention without visual feedback will them be tested again 24 hours later.	Behavioral: Exercise; Subjects will complete 5 minutes of exercise on an ergometer to examine the effects of exercise on retention of a newly learned walking pattern.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour retention	This is amount of learning that was retained when subjects return 24 hours later and are tested without visual feedback	24 hours

Collaborators and Investigators

• Sponsor: University of Delaware
• Investigators: Principal Investigator: Darcy Reisman, PhD, University of Delaware

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): January 31, 2025
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 1139080-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No