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Primary Clinical Science using the Juvent’s Micro-Impact Platform®

Effect of Low-Magnitude, High-Frequency Mechanical Stimulation on BMD Among Young Childhood Cancer Survivors – A Randomized Clinical Trial

JAMA Oncol. Published online March 10, 2016. doi:10.1001/jamaoncol.2015.6557

Summary
“The first goal of treating low BMD in childhood cancer survivors is to manage potential underlying causes including endocrine disorders and nutritional deficiencies. In our study using LMS (Juvent® Dynamic Motion Therapy Platform), we managed endocrine problems and supplemented everyone on the study. Our randomized study was effective in improving total body and tibial BMD in children randomized to the device while children in the placebo group had decreases in BMD. Importantly, we had no adverse events with a year of twice daily 10 minute sessions. This portable device is safe and effective as an intervention for childhood cancer survivors who have low BMD and whose endocrine and nutrition status is well managed.”
Kirsten K. Ness, PT, PhD – St. Jude Children’s Research Hospital

Effect of Low Magnitude Mechanical Stimuli on Bone Density and Structure in Pediatric Crohn’s Disease: A Randomized Placebo Controlled Trial.

J Bone Miner Res. 2016 Jan 29. doi: 10.1002/jbmr.2799.

The effect of whole body vibration therapy on bone density in patients with thalassemia:
A pilot study

American Journal of Hematology, 2012 


Effect of whole body vibration (WBV) therapy on bone density and bone quality in osteopenic girls with adolescent idiopathic scoliosis: a randomized, controlled trial

Osteoporos Int DOI 10.1007/s00198-012-2144-1


Effect of High Frequency, Low Magnitude Vibration on Bone and Muscle in Children with Cerebral Palsy

J Pediatr Orthop. 2010 ; 30(7): 732–738. doi:10.1097/BPO.0b013e3181efbabc.


Reversal of Lower-limb Edema by Calf Muscle Pump Stimulation.

J. Cardiopulmonary Rehab. & Prevention. 28:174-179. (2008)

Shows Juvent stimulation reverses fluid pooling in the lower limbs. It offers a simple counter-measure to address a problem affecting 40% of adult women.


Low-Level, High-Frequency Mechanical Signals Enhance Musculoskeletal Development of Young Women With Low BMD

J Bone Miner Res 2006; 21:1464–1474. Published online on June 26, 2006; doi: 10.1359/JBMR.060612


Plantar vibration improves leg fluid flow in perimenopausal women.

Am.J. Physiol. Regul. Intergr. Comp. Physiol. 288:R623-R629 (2005)

Shows Juvent increases in peripheral, systemic blood flow, peripheral lymphatic flow and venous drainage from the lower limb, thereby providing an efficient, potential counter-measure for patients with inefficient calf muscle pump (most elderly or immobile people).


Prevention of Postmenopausal Bone Loss by a Low-Magnitude, High-Frequency Mechanical Stimuli: A clinical Trial Assessing Compliance, Efficacy, and Safety.

(Journal of Bone and Mineral Research, Vol.19, Number 3, 2004)

 


Low level, high frequency vibrational loading can be safely and efficiently applied to the human skeleton, with approximately 80% of the loads reaching the hip and spine in the standing or sitting human.

Transmissibility of 15-Hertz to 35-Hertz Vibrations to the Human Hip and Lumbar Spine: Determining the Physiologic Feasibility of Delivering Low-Level Anabolic Mechanical Stimuli to Skeletal Regions at Greatest Risk of Fracture Because of Osteoporosis.
Spine, Vol. 28, No. 23, pp 2621-2627, 2003.


Significant improvements in muscle dynamics resulted from treatment with the Juvent DMT device. Postural stability was significantly improved in an eight week study; Type IIa muscle fiber activity was significantly increased in older (> 65 years) women; and neuro-muscular activity was significantly improved as reflected in the response of peri- and post-menopausal women to orthostatic stress.

The role of postural sway in the maintenance of bone mass. Trans. Am. Soc. Bone & Min. Res. 2002, Frequency dependent response of the cardio-vascular system to foot based vibration while in the seated position. Trans. Biomed. Eng. Soc., 2002

 


A clinical trial on children with cerebral palsy demonstrated an 11% increase in trabecular bone density in the tibia following six months of treatment, in contrast to the 6% loss of bone mineral density in children standing on placebo devices.

Low Magnitude Mechanical Loading is Osteogenic in Children with Disabling Conditions. J Bone Min Res, accepted for publication, March, 2004.

In summary, this pilot RCT in children with disabling conditions provides evidence that short durations of extremely low magnitude high frequency mechanical loading can significantly increase vTBMD of the proximal tibia, with a positive trend observed in the spine. These data are indicative of the potential of this unique, biomechanically based intervention to offer a non-pharmacological, non-invasive method to increase low trabecular bone mineral density in humans.


A clinical trial on adolescent females (10-13yr) with osteoporosis showed a significant increase in BMD of both cortical and trabecular bone of the tibia, as well as an increase in muscle mass of the thigh, following two months of treatment.

Short Term Low Level Mechanical Stimulation Increases Cancellous and Cortical Bone Density and Muscles of Females with Osteoporosis: A Pilot Study. Endocrine Society Transactions in press. 2002.

This data indicates that the Juvent low amplitude, high frequency device is an effective, non-pharmacologic means of significantly increasing bone density in the cancellous bone of the lower appendicular spine (CaBD) and in the cortical bone of the femurs (CoBD) of children with osteopenia or osteoporosis as well as increasing muscle mass over the femurs in the short term period.


This clinical study assessed compliance with standing for 10 minutes/day on a Juvent DMT device. The compliance with the required daily use period and the satisfaction with the daily use of the device was assessed in the target population for osteoporosis therapy, elderly women.

Establishing the Compliance in Elderly Women for Use of a Low Level Mechanical Stress Device in a Clinical Osteoporosis Study

Conclusions: Elderly women showed high compliance, high satisfaction and few adverse experiences with a daily non-pharmacologic treatment designed to inhibit bone loss. Larger randomized controlled trials should evaluate the long-term efficacy of vibrating platform devices for treatment of low bone mass and osteoporosis in elderly individuals.