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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02847988
Other study ID # AXJ014
Secondary ID R01NR016055
Status Recruiting
Phase N/A
First received
Last updated
Start date July 2016
Est. completion date April 2022

Study information

Verified date March 2021
Source RML Specialty Hospital
Contact Lisa A Duffner, B.A.,B.S.
Phone 630-286-4149
Email lmikolajewski@rmlspecialtyhospital.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary aim of this proposal is to test the effectiveness of neuromuscular electrical stimulation (NMES) in improving functional status and muscle function in patients receiving prolonged mechanical ventilation.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date April 2022
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Duration of mechanical ventilation >14 days - Sufficiently awake - Able to speak and comprehend English - Willingness to participate Exclusion Criteria: - Cardiopulmonary Instability - Acute-onset neuromuscular disease - Lower-extremity amputee or paresis - Open wound at electrode application points - Pitting edema grade =3 - Presence of pacemaker, implanted defibrillator, or ventricular-assist device - inability to transfer from sitting to standing before critical illness

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Neuromuscular electrical Stimulation (NMES)
Electrical stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo). The intensity of stimulation will be titrated based on maximal tolerable muscle contraction
Sham Stimulation
Sham stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo).

Locations

Country Name City State
United States RML Specialty Hospital Hinsdale Illinois

Sponsors (2)

Lead Sponsor Collaborator
RML Specialty Hospital National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to reach independence in performing functional activity Functional activity as measured by functional activity measurement for the ICU (FSS-ICU) Hospital discharge, an expected average stay of 5 weeks
Secondary The percentage of patients who can perform functional activities independently Percentage of patients with an FSS-ICU score = 25 at discharge from LTACH Hospital discharge, an expected average stay of 5 weeks
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