Recruiting

NMES

Sponsor:

RML Specialty Hospital

Code:

NCT02847988

Conditions

Muscle Weakness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neuromuscular electrical Stimulation (NMES)

Sham Stimulation

Study Details

Brief summary:

The primary aim of this proposal is to test the effectiveness of neuromuscular electrical stimulation (NMES) in improving functional status and muscle function in patients receiving prolonged mechanical ventilation.

Conditions

Muscle Weakness

Study ID

NCT02847988

Start date

Jul, 2016

Status verified date

Mar, 2021

Completion date

Apr, 2022

Anticipated

Primary completion date

Nov, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Duration of mechanical ventilation >14 days
  • Sufficiently awake
  • Able to speak and comprehend English
  • Willingness to participate

Exclusion Criteria:

  • Cardiopulmonary Instability
  • 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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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

sham comparator: 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

Interventions

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).

Primary outcome measure

  • Time to reach independence in performing functional activity [ Time Frame: Hospital discharge, an expected average stay of 5 weeks ]

Central Contacts and Locations

Central contacts

Lisa A Duffner, B.A.,B.S.

630-286-4149lmikolajewski@rmlspecialtyhospital.org

Amal Jubran, MD

708-202-2705ajubran@lumc.edu

Locations

RML Specialty Hospital

Recruiting

Hinsdale, Illinois, United States, 60521

Contacts

Lisa Duffner

630-286-4149lmikolajewski@rmlspecialtyhospital.org

Maryann Oliver

630-286-4127

Principal Investigator:

Amal Jubran, MD

More Information

Sponsor

RML Specialty Hospital

Last update posted

Mar 11, 2021

Last verified

Mar, 2021

Keywords

  • muscle strength
  • muscle function
  • functional status

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by RML Specialty Hospital on 2021-03-11.