Recruiting
Early Phase 1

Observational Study

Sponsor:

University of Southern California

Code:

NCT04829071

Conditions

Stroke

CVA (Cerebrovascular Accident)

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Explicit motor learning

Implicit motor learning

Study Details

Brief summary:

This project seeks to determine how post-stroke cognitive impairment moderates motor learning during walking in older adults with chronic stroke and identify brain structural markers that mediate this relationship. The chosen experimental design integrates biomechanical analyses, neuropsychological assessments, and brain imaging techniques to determine the impact of post-stroke cognitive impairment severity on two forms of motor learning (explicit and implicit) and examine the role of the dorsolateral prefrontal cortex in the relationship between cognition and explicit motor learning. Ultimately, this work may lead to the development of a more comprehensive, effective treatment approach to improve walking dysfunction in older adults post-stroke.

Conditions

Stroke

CVA (Cerebrovascular Accident)

Study ID

NCT04829071

Start date

Jan 16, 2023

Status verified date

Oct, 2025

Completion date

Dec 14, 2026

Anticipated

Primary completion date

Aug 14, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Unilateral stroke
  • Stroke occurred more than 6 months prior
  • Paresis confined to one side
  • Independently ambulatory (including the use of assistive devices)
  • Able to walk for 5 minutes without stopping
  • Answers no to all general health questions on the PAR-Q+
  • Willingness to complete study procedures

Exclusion Criteria:

  • Brainstem or cerebellar stroke
  • Aphasia (expressive, receptive, or global)
  • Any major musculoskeletal or non-stroke neurological condition that interferes with the assessment of sensorimotor or cognitive function
  • Metal in the head (except in the mouth), implanted cranial or thoracic devices that violate MRI safety regulations
  • Uncontrolled hypertension (>160/110mmHg)
  • Concurrent physical therapy
  • Claustrophobia
  • Significant cognitive deficit or dementia (<20 on MoCA)
  • Inability to give informed consent

Study Design

Enrollment

65 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Evaluating motor learning and brain structures post-stroke

We will use a single arm design to determine the impact of post-stroke cognitive impairment on two forms of motor learning (implicit and explicit) and evaluate the structural integrity of relevant brain structures in 65 individuals post stroke

Interventions

Explicit motor learning

Participants will be provided with visual feedback of their right and left step lengths on a screen in front of a treadmill.

Implicit motor learning

Participants will walk on a treadmill that drives their right and left legs to move at two different speeds.

Primary outcome measure

  • step length asymmetry - change in performance [ Time Frame: Measured at three timepoints of interest within each testing session: baseline and at the beginning and end of the interventions; participants will complete 2 testing sessions over approximately 1 months ]

Central Contacts and Locations

Central contacts

Kristan Leech, PT, DPT, PhD

(323) 442-1583kleech@pt.usc.edu

Sarah Kettlety, MS

(323) 442-1196kettlety@usc.edu

Locations

Center for Health Professions

Recruiting

Los Angeles, California, United States, 90033

Contacts

Kristan Leech, PT, DPT, PhD

3124421583

More Information

Sponsor

University of Southern California

Last update posted

Nov 4, 2025

Last verified

Oct, 2025

Keywords

  • stroke
  • walking
  • rehabilitation
  • cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2025-11-04.