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Sponsors and Collaborators: |
Binghamton University Juvent, Inc New york State Office of Science Technology and Academic Research |
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Information provided by: | Binghamton University |
ClinicalTrials.gov Identifier: | NCT00397462 |
This project will test the efficacy of using a non-invasive neuromuscular stimulation on the plantar surface of the feet to prevent and/ or reverse bone loss in a sample of healthy adult women.
Condition | Intervention | Phase |
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Bone Loss Muscle Tone Poor |
Device: plantar micromechanical stimulation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 45 |
Study Start Date: | October 2006 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Women between the ages of 30 and 60 years of age who work in positions that require them to be seated at desks for a large portion of each day, are capable of following the protocol for one year, have a t-score >- 2.5 (do not have osteoporosis), and respond to plantar stimulation will be asked to participate. The subjects will be asked to complete a detailed health history and health habits survey that will focus on issues related to risk factors for osteoporosis. Women will be excluded who are receiving medications for osteoporosis, taking hormone replacement therapy, taking steroids (either oral or inhaled), have metal implants in the tibia, hip and spine that interfere with DEXA (bone density) scanning, are professional or semi-professional athletes, have hyperparathyroidism, have a history of pulmonary embolism, deep vein thrombosis, peripheral vascular disease or varicose veins, have a Body Mass Index greater than 40 Kg/m2, have any type of neuromuscular disease, or are pregnant . Once the inclusion and exclusion criteria are met, 45 subjects will be randomized into 3 groups including 1) a group of 15 subjects who will use the device (stimulation) for up to 4 hours a day, 2) a group of 15 subjects that will use the device for up to 8 hours a day, and 3) a control group who will not use the device. Subjects in the two treatment groups will be asked to place their feet on a mechanical device that will deliver a slight vibration while they are seated at work. Vibrations between 30-60 Hz has been shown to stimulate the Meissner's corpuscles which in turn stimulate contraction of the deep muscles of the calves. This contraction has been shown to increase venous and lymphatic return from the lower extremities thus improve bone metabolism. Bone density readings and venous circulation will be measured at the onset of this research and will be repeated after 12 months of using the device. Venous circulation will be reassessed at 3 months and 6 months as well. The health history and lifestyle information will be assessed at each of three month intervals to discover any changes that might impact the efficacy of this research.
Ages Eligible for Study: | 30 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
CSERC Binghamton University | |
Binghamton, New York, United States, 13902 |
Principal Investigator: | Kenneth McLeod, PhD | Binghamton University SUNY, BioEngineering |
Responsible Party: | Binghamton University, SUNY Bioengineering ( Kenneth McLeod ) |
Study ID Numbers: | CSERC-005 |
Study First Received: | November 7, 2006 |
Last Updated: | April 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00397462 |
Health Authority: | United States: Institutional Review Board |
Osteoporosis Sarcopenia Calf muscle pump Venous insufficiency |
DEXA Soleus muscle APG |
Signs and Symptoms Muscle Hypotonia Venous Insufficiency |
Neurologic Manifestations Osteoporosis Healthy |
Neuromuscular Manifestations Nervous System Diseases |