Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury
Completed · Not applicable
Conditions studied: Spinal Cord Injuries
In brief
The purpose of this research study is to determine the effect of mechanical vibrations on bones of persons with spinal cord injury.
Key facts
- Study ID
- NCT00886145
- Run by
- William A. Bauman, M.D.
- People needed
- 1
- Starts
- 2009-06-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2016-04-28
Who can join
Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Males;
- Age 18-65;
- Non-ambulatory SCI, with ASIA level A or B (ASIA A or B at the time of enrollment);
- Neurological level of injury C3-T10;
- 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).
You may not qualify if…
- Osteoporosis or low bone mass as determined by medical history or DXA at the baseline visit;
- Pressure ulcer that may be exacerbated by the experimental procedure;
- Fracture of the lower extremity within the past 5 years;
- Active heterotopic ossification (HO);
- History of metabolic bone disease;
- Knee replacement(s);
- Metal hardware in the lower extremities;
- Bisphosphonate administration;
- Severe underlying chronic illness (cardiac, pulmonary, gastrointestinal, etc.);
- Renal disease (creatinine clearance < 40 mL/min);
- 25(OH)D levels <30ng/ml;
- Endocrine disorders known to be associated with osteoporosis (hyperthyroidism, hypercortisolism, and/or hypogonadism);
- Alcoholism;
- Seizure disorders;
- History of kidney stones; and
- Compliance 85% for every month up to the 4-month time-point
Where it is running
- VA Medical Center, Bronx — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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