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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01825135
Other study ID # AXJ012
Secondary ID
Status Completed
Phase N/A
First received March 28, 2013
Last updated May 1, 2017
Start date March 2011
Est. completion date August 2016

Study information

Verified date May 2017
Source RML Specialty Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date August 2016
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Neuromuscular electrical stimulation

sham stimulation
sham stimulation will be applied to the quadriceps

Locations

Country Name City State
United States RML Specialty Hospital Hinsdale Illinois

Sponsors (1)

Lead Sponsor Collaborator
RML Specialty Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary modified Functional Independence Measurement (FIM) score Functional status as measured by modified Functional Independence Measurement (FIM) score Hospital discharge, an expected average stay of 5 weeks
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