Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation
NCT ID: NCT02847988
Last Updated: 2021-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2016-07-31
2022-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Neuro-muscular electrical stimulation
Intervention:Neuromuscular electrical stimulation (NMES)
NMES stimulation will be applied to lower extremity muscle groups up to 5 days a week until discharge. Standard physical therapy will also be administered by a therapist distinct from the therapist administering NMES
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
Intervention: sham stimulation
Sham stimulation will be applied to lower extremity muscle groups up to 5 days a week until discharge. Standard physical therapy will also be administered by a therapist distinct from the therapist administering sham-NMES
Sham Stimulation
Sham stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Sufficiently awake
* Able to speak and comprehend English
* Willingness to participate
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
RML Specialty Hospital
OTHER
Responsible Party
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Amal Jubran
Principal Investigator-Staff Physician
Principal Investigators
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Amal Jubran, MD
Role: PRINCIPAL_INVESTIGATOR
RML Specialty Hospital
Locations
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RML Specialty Hospital
Hinsdale, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Maryann Oliver
Role: backup
Other Identifiers
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AXJ014
Identifier Type: -
Identifier Source: org_study_id
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