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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05801744
Other study ID # 1656292
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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