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OpenTrials
Completed

NCT Number: NCT01811446

Evaluation of Muscle Activation Efficiency in Challenging Subjects

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.

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Key information

Conditions

Obesity Body Weight COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fogarty Clinical Research

Mountain View, California, 94040, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Muscle Activation with Niveus and Intelect Devices

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.

Primary outcomes

  1. Intensity Required

    Time frame: During treatment

    Intensity required to achieve target levels of muscle contraction

Secondary outcomes

  1. Comfort

    Time frame: During treatment

    Comfort of stimulation will be assessed at various intensity levels using a widely-used discomfort scale

Sponsors and collaborators

Lead sponsor

Niveus Medical, Inc.

Industry

Registry information

Official study title

Evaluation of Muscle Stimulation Efficiency in Challenging Subjects: A Pilot Study

Important dates

Study start
2013
Primary completion
2013
First posted
Mar 14, 2013
Registry last updated
Jan 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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