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Clinical Trials/NCT04829071
NCT04829071
Recruiting
Early Phase 1

Cognition as a Moderator of Motor Learning Post-stroke

University of Southern California1 site in 1 country65 target enrollmentJanuary 16, 2023

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Southern California
Enrollment
65
Locations
1
Primary Endpoint
step length asymmetry - change in performance
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 16, 2023
End Date
December 14, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kristan Leech

Principal Investigator

University of Southern California

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • step length asymmetry - immediate retention(Measured after motor learning in each testing session; participants will complete 2 testing sessions over approximately 1 months)

Study Sites (1)

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