Cognition and Motor Learning Post-stroke

Stroke Clinical Trial

Official title:

Cognition as a Moderator of Motor Learning Post-stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04829071
• Other study ID #: APP-21-00898
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 16, 2023
• Est. completion date: August 14, 2025

Study information

• Verified date: July 2023
• Source: University of Southern California
• Contact: Kristan Leech, PT, DPT, PhD
• Phone: (323) 442-1583
• Email: kleech[@]pt.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: August 14, 2025
• Est. primary completion date: August 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• CVA (Cerebrovascular Accident)
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	Center for Health Professions	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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