search
Back to results

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

Primary Purpose

Stroke, Post-stroke Hemiparesis, Foot Drop

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Operant conditioning
Sponsored by
University of Nevada, Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Nevada, Las VegasRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reciprocal inhibition up conditioning

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in magnitude of reciprocal inhibition

Secondary Outcome Measures

Full Information

First Posted
March 24, 2023
Last Updated
March 24, 2023
Sponsor
University of Nevada, Las Vegas
search

1. Study Identification

Unique Protocol Identification Number
NCT05801744
Brief Title
Operant Conditioning of Reflex Pathways to Improve Walking in Individuals Post-stroke
Official Title
Operant Conditioning of Reflex Pathways to Improve Walking in Individuals Post-stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nevada, Las Vegas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Post-stroke Hemiparesis, Foot Drop

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reciprocal inhibition up conditioning
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Operant conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Nevada, Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Nong Liang, PT, PhD
Phone
702-895-4936
Email
jingnong.liang@unlv.edu
First Name & Middle Initial & Last Name & Degree
Jing Nong Liang, PT, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs