Cognition and Motor Learning Post-stroke

Cognition as a Moderator of Motor Learning Post-stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; CVA (Cerebrovascular Accident)
• Intervention / Treatment: Behavioral: Explicit motor learning; Behavioral: Implicit motor learning

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Sarah Kettlety, MS; Phone Number: (323) 442-1196; Email: kettlety@usc.edu
• Study Contact Backup: Name: Kristan Leech, PT, DPT, PhD; Phone Number: (323) 442-1583; Email: kleech@pt.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Center for Health Professions
      • Contact: Kristan Leech, PT, DPT, PhD; Phone Number: 312-442-1583

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: 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.; Behavioral: Implicit motor learning; Participants will walk on a treadmill that drives their right and left legs to move at two different speeds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
step length asymmetry - immediate retention	characterized as a comparison between the right and left step lengths; captured to quantify the retention of a newly learned walking pattern	Measured after motor learning in each testing session; participants will complete 2 testing sessions over approximately 1 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Kristan Leech, PT, DPT, PhD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Estimated): August 14, 2025
• Study Completion (Estimated): August 14, 2025

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 8, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; cognition; walking
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: APP-21-00898

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All de-identified data from our research that underlie results in a publication will be made available on the Open Science Framework.
• IPD Sharing Time Frame: data will be made available 6 months after publication
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No