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Evaluation of Muscle Activation Efficiency in Challenging Subjects

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ClinicalTrials.gov Identifier: NCT01811446
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : January 31, 2014
Sponsor:
Information provided by (Responsible Party):
Niveus Medical, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity COPD Device: Muscle Activation with Niveus and Intelect Devices Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Muscle Stimulation Efficiency in Challenging Subjects: A Pilot Study
Study Start Date : March 2013
Actual Primary Completion Date : September 2013

Arm Intervention/treatment
Experimental: Obese
Subjects with BMI > 30
Device: Muscle Activation with Niveus and Intelect Devices
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
Device: Muscle Activation with Niveus and Intelect Devices
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.




Primary Outcome Measures :
  1. Intensity Required [ Time Frame: During treatment ]
    Intensity required to achieve target levels of muscle contraction


Secondary Outcome Measures :
  1. Comfort [ Time Frame: During treatment ]
    Comfort of stimulation will be assessed at various intensity levels using a widely-used discomfort scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811446


Locations
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United States, California
Fogarty Clinical Research
Mountain View, California, United States, 94040
Sponsors and Collaborators
Niveus Medical, Inc.
Investigators
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Principal Investigator: Bahman Nouri, MD El Camino Hospital

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Responsible Party: Niveus Medical, Inc.
ClinicalTrials.gov Identifier: NCT01811446     History of Changes
Other Study ID Numbers: CLP-2.00
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: January 31, 2014
Last Verified: January 2014