Evaluation of Muscle Activation Efficiency in Challenging Subjects

NCT ID: NCT01811446

Last Updated: 2014-01-31

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Obese

Subjects with BMI \> 30

Group Type EXPERIMENTAL

Muscle Activation with Niveus and Intelect Devices

Intervention Type DEVICE

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.

COPD

Non-hospitalized COPD patients

Group Type EXPERIMENTAL

Muscle Activation with Niveus and Intelect Devices

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Niveus Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bahman Nouri, MD

Role: PRINCIPAL_INVESTIGATOR

El Camino Hospital

Locations

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Fogarty Clinical Research

Mountain View, California, United States

Site Status

Countries

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United States

Other Identifiers

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CLP-2.00

Identifier Type: -

Identifier Source: org_study_id