Effect of All-Stim 2 Quadriceps Treatments on Limb Muscle Strength In Mechanically Ventilated Patients

NCT02332187 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-03-02

Study results available
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Summary

Patients that are on mechanical ventilators in medical intensive care units (MICU) have extremely weak leg muscles. Currently there is no treatment to prevent or reverse this weakness. Treatments with a thigh muscle stimulator, called an All Stim 2, can improve leg muscle strength and help patients regain leg function after knee surgery. The purpose of the present study is to determine if treatments with the All Stim 2 device can also improve leg muscle strength in patients on mechanical ventilation.

Conditions

  • Weakness

Interventions

DEVICE

Active electrical stimulation using an All Stim stimulator

This is an FDA approved stimulator that is used for strengthening the quadriceps muscle.

DEVICE

Sham electrical stimulation using an All Stim stimulator

With this intervention the All Stim unit is turned off and no electrical stimulation is provided.

Sponsors & Collaborators

  • Gerald Supinski

    lead OTHER

Principal Investigators

  • Gerald S Supinski, MD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-03
Primary Completion
2017-05-05
Completion
2017-05-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02332187 on ClinicalTrials.gov