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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801744
• Other study ID #: 1656292
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: University of Nevada, Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Foot Drop
• Paresis
• Peroneal Neuropathies
• Post-stroke Hemiparesis
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of Nevada, Las Vegas	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in magnitude of reciprocal inhibition		Before training Baseline, after completion of 30 training sessions, and 1 month after the completion of intervention