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NCT01825135 Clinical Trial

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

Muscle Weakness Clinical Trial

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

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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