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

• Sponsor: University of Nevada, Las Vegas (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05801744
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 41
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Post-stroke Hemiparesis; Foot Drop	Behavioral: Operant conditioning	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Operant Conditioning of Reflex Pathways to Improve Walking in Individuals Post-stroke
• Actual Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in magnitude of reciprocal inhibition [Before training Baseline, after completion of 30 training sessions, and 1 month after the completion of intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nevada, Las Vegas	Las Vegas	Nevada	United States	89154

Sponsors and Collaborators

• University of Nevada, Las Vegas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Nevada, Las Vegas
• ClinicalTrials.gov Identifier: NCT05801744
• Other Study ID Numbers: 1656292
• First Posted: Apr 6, 2023
• Last Update Posted: Apr 6, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Paresis; Peroneal Neuropathies

Study Results

No Results Posted as of Apr 6, 2023