Evaluation of Muscle Activation Efficiency in Challenging Subjects

Niveus Medical

Status: Completed

Conditions: Obesity; COPD

Treatments: Device: Muscle Activation with Niveus and Intelect Devices

Study type: Interventional

Funder types: Industry

Identifiers

NCT01811446

CLP-2.00

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Obese

Experimental group

Description:

Subjects with BMI \> 30

Treatment:

Device: Muscle Activation with Niveus and Intelect Devices

COPD

Experimental group

Description:

Non-hospitalized COPD patients

Treatment:

Device: Muscle Activation with Niveus and Intelect Devices