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Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2

NCT03688282 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-04-27

Study results available
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Summary

The wearable vibration device aims to consistently deliver vibrations directly to the hip and spine and allowing use during many everyday activities. We propose that demonstrating higher rates of compliance and consistent delivery of optimal force, with accelerometer feedback, will provide a superior alternative to whole body vibration and is plausibly more effective at preventing bone loss in postmenopausal women than vibration platforms in the home setting.

Conditions

  • Osteopenia

Interventions

DEVICE

Wearable vibration belt

The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.

DEVICE

Sham, wearing belt

The device is worn, for a specified time. It will not be turned on during this period. It is only sham.

Sponsors & Collaborators

  • University of Nebraska

    collaborator OTHER

  • Theranova, L.L.C.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-11
Primary Completion
2018-11-29
Completion
2019-04-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03688282 on ClinicalTrials.gov