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Exercise and Motor Learning After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03726047
Recruitment Status : Active, not recruiting
First Posted : October 31, 2018
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Delaware

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Feedback and Cognition During Locomotor Learning Post Stroke
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 24 hour retention [ Time Frame: 24 hours ]
    This is amount of learning that was retained when subjects return 24 hours later and are tested without visual feedback



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726047


Locations
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United States, Delaware
University of Delaware
Newark, Delaware, United States, 19713
Sponsors and Collaborators
University of Delaware
Investigators
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Principal Investigator: Darcy Reisman, PhD University of Delaware

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Responsible Party: University of Delaware
ClinicalTrials.gov Identifier: NCT03726047    
Other Study ID Numbers: 1139080-3
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases