Operant Conditioning of Reflex Pathways to Improve Walking in Individuals Post-stroke

March 24, 2023 updated by: University of Nevada, Las Vegas
The purpose of this study is to examine the changes in reflex pathways in the paretic ankle plantarflexors in individuals with post-stroke hemiparesis using operant conditioning. We are recruiting 5 individuals with chronic post-stroke hemiparesis with foot drop in the affected leg to participate in the reflex training procedure. The study involves 40 visits with a total study duration of about 4 months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89154
        • Recruiting
        • University of Nevada, Las Vegas
        • Contact:
        • Principal Investigator:
          • Jing Nong Liang, PT, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 6 months following a single, unilateral stroke, resulting in hemiparesis.
  • Ambulatory with or without assistive device, but must demonstrate a gait deficit which is indicative of foot drop from reduced activation of the tibialis anterior muscle.
  • Able to follow verbal directions.
  • Able to see icons on computer monitor (with or without corrective lenses) from at least 4 feet away.
  • All subjects will be adults at least 18 years old.
  • Know history and current medication management for lower limb spasticity, if any.

Exclusion Criteria:

  • No history of ear disease or balance problems outside of those caused by the stroke.
  • Cerebellar stroke
  • No other neurological disease or injuries other than the stroke affecting the use of the legs and/or walking.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reciprocal inhibition up conditioning
Each participant completes 6 baseline sessions and 30 up conditioning sessions. In the 30 conditioning sessions, the magnitude of reciprocal inhibition in the paretic leg of participants post-stroke will be up conditioned.
Behavioral: Operant conditioning
In this training, individuals with post-stroke hemiparesis are trained to increase the amount of reciprocal inhibition in their paretic leg. By increasing the amount of reciprocal inhibition, the paretic ankle in people post-stroke may exhibit less foot drop.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in magnitude of reciprocal inhibition
Time Frame: Before training Baseline, after completion of 30 training sessions, and 1 month after the completion of intervention
Before training Baseline, after completion of 30 training sessions, and 1 month after the completion of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nevada, Las Vegas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1656292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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