Cognition and Motor Learning Post-stroke

NCT04829071 | Recruiting Early Phase 1

• 1 other identifier: APP-21-00898
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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)

Keywords

stroke; walking; rehabilitation; cognition

Outcome Measures

Primary Outcomes (1)

• step length asymmetry - change in performance

  characterized as a comparison between the right and left step lengths; captured to quantify change in performance with biofeedback or split belt walking

  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

Secondary Outcomes (1)

• step length asymmetry - immediate retention

  Measured after motor learning in each testing session; participants will complete 2 testing sessions over approximately 1 months

Study Arms (1)

Evaluating motor learning and brain structures post-stroke

EXPERIMENTAL

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

Behavioral: Explicit motor learning; Behavioral: Implicit motor learning

Interventions

Explicit motor learning BEHAVIORAL

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

Evaluating motor learning and brain structures post-stroke

Implicit motor learning BEHAVIORAL

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

Evaluating motor learning and brain structures post-stroke

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Center for Health Professions

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kristan Leech, PT, DPT, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristan Leech, PT, DPT, PhD

CONTACT

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

Sarah Kettlety, MS

CONTACT

(323) 442-1196; kettlety@usc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 2, 2021
• Study Start: January 16, 2023
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: data will be made available 6 months after publication

Locations

US (1)