NCT03726047

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
8mo left

Started Dec 2019

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Dec 2019Feb 2027

First Submitted

Initial submission to the registry

October 30, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

7.2 years

First QC Date

October 30, 2018

Last Update Submit

May 19, 2026

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control

NO INTERVENTION

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).

Exercise

EXPERIMENTAL

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

Interventions

ExerciseBEHAVIORAL

Subjects will complete 5 minutes of exercise on an ergometer to examine the effects of exercise on retention of a newly learned walking pattern.

Exercise

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

RECRUITING

Related Publications (1)

  • Thompson ED, Bhat S, French MA, Morton S, Pohlig RT, Reisman DS. Effects of an Acute High Intensity Exercise Bout on Retention of Explicit, Strategic Locomotor Learning in Individuals With Chronic Stroke. Neurorehabil Neural Repair. 2023 Sep;37(9):628-639. doi: 10.1177/15459683231195039. Epub 2023 Aug 30.

    PMID: 37646138DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Darcy Reisman, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Darcy Reisman, PhD

CONTACT

3028310508dreisman@udel.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2018

First Posted

October 31, 2018

Study Start

December 1, 2019

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)