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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03726047
Other study ID # 1139080-3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date March 31, 2025

Study information

Verified date May 2023
Source University of Delaware
Contact Darcy Reisman, PhD
Phone 3028310508
Email dreisman@udel.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date March 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Delaware Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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