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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01825135
Enrollment
57
Registered
2013-04-05
Start date
2011-03-31
Completion date
2016-08-31
Last updated
2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Weakness

Keywords

muscle strength, muscle function, functional status

Brief 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

Interventions

DEVICENeuromuscular electrical stimulation
DEVICEsham stimulation

sham stimulation will be applied to the quadriceps

Sponsors

RML Specialty Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
modified Functional Independence Measurement (FIM) scoreHospital discharge, an expected average stay of 5 weeksFunctional status as measured by modified Functional Independence Measurement (FIM) score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026