Electrical Stimulation to Strengthen Muscles in the Lower Legs in Patients Requiring Prolonged Mechanical Ventilation

May 1, 2017 updated by: Amal Jubran, RML Specialty Hospital

Electrical Stimulation to Strengthen the Quadriceps Muscles in Patients Requiring Prolonged Mechanical Ventilation

The primary aim of this proposal is to test the effectiveness of NMES in improving functional status and muscle function in patients requirng prolonged mechanical ventilation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • RML Specialty Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • duration of mechanical ventilation for 14 days or more
  • sufficiently awake
  • able to speak and comprehend English

Exclusion Criteria:

  • known primary neuromuscular disease
  • lower extremities paresis or amputee
  • patients with left-ventricular assist device (LVAD)
  • cardiopulmonary instability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuromuscular electrical stimulation
Neuromuscular electrical stimulation (NMES) will be applied to the quadriceps muscles for 30 minutes
Device: Neuromuscular electrical stimulation
Other Names:
  • 300PV™ neuromuscular stimulation (NMES)device
Sham Comparator: Sham stimulation
Sham stimulation will be applied to the quadriceps for 30 minutes
Device: sham stimulation
sham stimulation will be applied to the quadriceps
Other Names:
  • 300PV™ Neuromuscular Stimulation (NMES) device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Functional Independence Measurement (FIM) score
Time Frame: Hospital discharge, an expected average stay of 5 weeks
Functional status as measured by modified Functional Independence Measurement (FIM) score
Hospital discharge, an expected average stay of 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RML Specialty Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXJ012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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