Status:
COMPLETED
Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury
Lead Sponsor:
William A. Bauman, M.D.
Collaborating Sponsors:
Kessler Foundation
Conditions:
Spinal Cord Injuries
Eligibility:
MALE
18-65 years
Phase:
NA
Brief Summary
The purpose of this research study is to determine the effect of mechanical vibrations on bones of persons with spinal cord injury.
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 me...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00886145
Start Date
June 1 2009
End Date
December 1 2012
Last Update
April 28 2016
Active Locations (1)
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1
VA Medical Center, Bronx
The Bronx, New York, United States, 10468