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Cognition and Motor Learning Post-stroke

Primary Purpose

Stroke, CVA (Cerebrovascular Accident)

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Explicit motor learning

Implicit motor learning

About this trial

This is an interventional basic science trial for Stroke focused on measuring stroke, walking, rehabilitation, cognition

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Center for Health ProfessionsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evaluating motor learning and brain structures post-stroke

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04829071

First Posted

March 30, 2021

Last Updated

July 8, 2023

Sponsor

University of Southern California

1. Study Identification

Unique Protocol Identification Number

NCT04829071

Brief Title

Cognition and Motor Learning Post-stroke

Official Title

Cognition as a Moderator of Motor Learning Post-stroke

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 16, 2023 (Actual)

Primary Completion Date

August 14, 2025 (Anticipated)

Study Completion Date

August 14, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, CVA (Cerebrovascular Accident)

Keywords

stroke, walking, rehabilitation, cognition

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Evaluating motor learning and brain structures post-stroke

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Explicit motor learning

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Implicit motor learning

Intervention Description

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

Primary Outcome Measure Information:

Title

step length asymmetry - change in performance

Description

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

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

Secondary Outcome Measure Information:

Title

step length asymmetry - immediate retention

Description

characterized as a comparison between the right and left step lengths; captured to quantify the retention of a newly learned walking pattern

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kristan Leech, PT, DPT, PhD

Phone

(323) 442-1583

kleech@pt.usc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah Kettlety, MS

Phone

(323) 442-1196

kettlety@usc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristan Leech, PT, DPT, PhD

Organizational Affiliation

University of Southern California

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Health Professions

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristan Leech, PT, DPT, PhD

Phone

312-442-1583

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

Cognition and Motor Learning Post-stroke

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