- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01811446
Evaluation of Muscle Activation Efficiency in Challenging Subjects
January 29, 2014 updated by: Niveus Medical, Inc.
Evaluation of Muscle Stimulation Efficiency in Challenging Subjects: A Pilot Study
The purpose of this study is to determine whether muscle activation can be accomplished more effectively and comfortably in challenging subjects using novel configurations of an activation device.
A novel device will be compared side by side with a market leading device.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Mountain View, California, United States, 94040
- Fogarty Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI > 30 (Wing 1 of study)
- Non-hospitalized with confirmed diagnosis of COPD (Wing 2 of study)
Exclusion Criteria:
- Age < 18 years
- Subject has an implanted pacemaker/defibrillator
- Subject diagnosed with epilepsy
- Subject has implanted metallic femoral rods
- Subject is chair- or bed-bound
- Subject has neuromuscular disease or abnormalities
- Subject BMI > 45
- Evidence of disease or condition that, in the opinion of the investigator, may compromise the conduct of or results of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Obese
Subjects with BMI > 30
|
Subjects will receive muscle activation technology from the Niveus device on one leg and from the Intelect (commercially-available third-party) device on the other.
The order of use and the leg applied to will be randomized.
|
Experimental: COPD
Non-hospitalized COPD patients
|
Subjects will receive muscle activation technology from the Niveus device on one leg and from the Intelect (commercially-available third-party) device on the other.
The order of use and the leg applied to will be randomized.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intensity Required
Time Frame: During treatment
|
Intensity required to achieve target levels of muscle contraction
|
During treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comfort
Time Frame: During treatment
|
Comfort of stimulation will be assessed at various intensity levels using a widely-used discomfort scale
|
During treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bahman Nouri, MD, El Camino Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
March 12, 2013
First Submitted That Met QC Criteria
March 12, 2013
First Posted (Estimate)
March 14, 2013
Study Record Updates
Last Update Posted (Estimate)
January 31, 2014
Last Update Submitted That Met QC Criteria
January 29, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- CLP-2.00
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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