Electrical Stimulation to Strengthen Muscles in the Lower Legs 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

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Key information

Conditions

Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RML Specialty Hospital

Hinsdale, Illinois, 60521, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular Electrical Stimulation

Device

Other names: 300PV™ neuromuscular stimulation (NMES)device

Sham stimulation

Device

sham stimulation will be applied to the quadriceps

Other names: 300PV™ Neuromuscular Stimulation (NMES) device

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

RML Specialty Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2016
First posted: Apr 5, 2013
Registry last updated: May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed