Cognition and Motor Learning Post-stroke

Sponsor

University of Southern California (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04829071

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke CVA (Cerebrovascular Accident)	Behavioral: Explicit motor learning Behavioral: Implicit motor learning	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Cognition as a Moderator of Motor Learning Post-stroke

Anticipated Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

Aug 14, 2025

Anticipated Study Completion Date :

Aug 14, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

step length asymmetry - change in performance [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Southern California

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kristan Leech, Principal Investigator, University of Southern California

ClinicalTrials.gov Identifier:

NCT04829071

Other Study ID Numbers:

APP-21-00898

First Posted:

Apr 2, 2021

Last Update Posted:

Aug 24, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kristan Leech, Principal Investigator, University of Southern California

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Aug 24, 2022