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

Primary Purpose

Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation
sham stimulation
Sponsored by
RML Specialty Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness focused on measuring muscle strength, muscle function, functional status

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RML Specialty Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Neuromuscular electrical stimulation

Sham stimulation

Arm Description

Neuromuscular electrical stimulation (NMES) will be applied to the quadriceps muscles for 30 minutes

Sham stimulation will be applied to the quadriceps for 30 minutes

Outcomes

Primary Outcome Measures

modified Functional Independence Measurement (FIM) score
Functional status as measured by modified Functional Independence Measurement (FIM) score

Secondary Outcome Measures

Full Information

First Posted
March 28, 2013
Last Updated
May 1, 2017
Sponsor
RML Specialty Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01825135
Brief Title
Electrical Stimulation to Strengthen Muscles in the Lower Legs in Patients Requiring Prolonged Mechanical Ventilation
Official Title
Electrical Stimulation to Strengthen the Quadriceps Muscles in Patients Requiring Prolonged Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RML Specialty Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
Keywords
muscle strength, muscle function, functional status

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular electrical stimulation
Arm Type
Experimental
Arm Description
Neuromuscular electrical stimulation (NMES) will be applied to the quadriceps muscles for 30 minutes
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Sham stimulation will be applied to the quadriceps for 30 minutes
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical stimulation
Other Intervention Name(s)
300PV™ neuromuscular stimulation (NMES)device
Intervention Type
Device
Intervention Name(s)
sham stimulation
Other Intervention Name(s)
300PV™ Neuromuscular Stimulation (NMES) device
Intervention Description
sham stimulation will be applied to the quadriceps
Primary Outcome Measure Information:
Title
modified Functional Independence Measurement (FIM) score
Description
Functional status as measured by modified Functional Independence Measurement (FIM) score
Time Frame
Hospital discharge, an expected average stay of 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Jubran, MD
Organizational Affiliation
RML Specialty Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
RML Specialty Hospital
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States

12. IPD Sharing Statement

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

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