NCT05801744

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Aug 2022

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 6, 2023

Status Verified

March 1, 2023

Enrollment Period

3.4 years

First QC Date

March 24, 2023

Last Update Submit

March 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in magnitude of reciprocal inhibition

    Before training Baseline, after completion of 30 training sessions, and 1 month after the completion of intervention

Study Arms (1)

Reciprocal inhibition up conditioning

EXPERIMENTAL

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

Interventions

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.

Reciprocal inhibition up conditioning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154, United States

RECRUITING

MeSH Terms

Conditions

StrokePeroneal Neuropathies

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2023

First Posted

April 6, 2023

Study Start

August 1, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations