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Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury

This study has been completed.
Kessler Foundation
Information provided by (Responsible Party):
William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center Identifier:
First received: April 21, 2009
Last updated: March 28, 2016
Last verified: February 2016
The purpose of this research study is to determine the effect of mechanical vibrations on bones of persons with spinal cord injury.

Condition Intervention
Spinal Cord Injuries
Device: Vibration: Right Leg and No Vibration: Left Leg.

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Using Low-magnitude High Frequency Mechanical Stimulation of Bone in Persons With Subacute SCI

Resource links provided by NLM:

Further study details as provided by James J. Peters Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months [ Time Frame: The Percent Change in vBMD from Baseline to 6 months after Mechanical Stimulation Vibration Therapy ] [ Designated as safety issue: No ]
    Volumetric Bone Mineral Density of the Right and Left Distal Tibia as Determined by Peripheral Quantitative Computed Tomography

Enrollment: 1
Study Start Date: June 2009
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Vibration and No Vibration
Vibration: Right Leg and No Vibration: Left Leg.
Device: Vibration: Right Leg and No Vibration: Left Leg.

Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.

No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.

Detailed Description:

One of the major complications in persons with spinal cord injury (SCI) is marked bone loss because it greatly predisposes to skeletal fractures, even after minimal trauma. The use of low magnitude mechanical stimulation has been shown to be both safe and effective in improving bone mass and strength in animal studies. This modality has also been shown a beneficial effect in children with disability and in postmenopausal women. The investigators are interested in obtaining data to determine the possible benefits that mechanical intervention with vibratory stimulation may have on bone in individuals with subacute SCI (e.g., >1 month after injury but <1 year). Changes in bone density and mass of the leg and arm will be determined by dual energy X-ray absorptiometry (DXA); bone architecture of the distal leg and distal arm will be determined by peripheral quantitative computed tomography; circulating metabolic markers of bone will also be performed.


In persons with subacute spinal cord injury:

  1. To determine differences in bone mineral mass and parameters of bone structural integrity of the stimulated tibia versus the unstimulated tibia.
  2. To determine changes in the metabolic markers of bone resorption and formation in persons with subacute spinal cord injury.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males;
  2. Age 18-65;
  3. Non-ambulatory SCI, with ASIA level A or B (ASIA A or B at the time of enrollment);
  4. Neurological level of injury C3-T10;
  5. Duration of injury >1 month after injury but <1 year; and 6.25(OH)D levels 30ng/ml (patients with values <30ng/ml will be supplemented with vitamin D to normalize values prior to study participation).

Exclusion Criteria:

  1. Osteoporosis or low bone mass as determined by medical history or DXA at the baseline visit;
  2. Pressure ulcer that may be exacerbated by the experimental procedure;
  3. Fracture of the lower extremity within the past 5 years;
  4. Active heterotopic ossification (HO);
  5. History of metabolic bone disease;
  6. Knee replacement(s);
  7. Metal hardware in the lower extremities;
  8. Bisphosphonate administration;
  9. Severe underlying chronic illness (cardiac, pulmonary, gastrointestinal, etc.);
  10. Renal disease (creatinine clearance < 40 mL/min);
  11. 25(OH)D levels <30ng/ml;
  12. Endocrine disorders known to be associated with osteoporosis (hyperthyroidism, hypercortisolism, and/or hypogonadism);
  13. Alcoholism;
  14. Seizure disorders;
  15. History of kidney stones; and
  16. Compliance 85% for every month up to the 4-month time-point
  Contacts and Locations
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Please refer to this study by its identifier: NCT00886145

United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
William A. Bauman, M.D.
Kessler Foundation
Principal Investigator: William Bauman, MD VA Medical Center, Bronx
  More Information

Additional Information:
Responsible Party: William A. Bauman, M.D., Director, James J. Peters Veterans Affairs Medical Center Identifier: NCT00886145     History of Changes
Other Study ID Numbers: B4162C-10 
Study First Received: April 21, 2009
Results First Received: February 24, 2016
Last Updated: March 28, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by James J. Peters Veterans Affairs Medical Center:
Spinal Cord Injuries
Mechanical Stimulation
Vibration Plate

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System processed this record on October 21, 2016