Status:
COMPLETED
Feasibility Study for the Use of Low-magnitude, High Frequency Mechanical Stimulation of Bone in Persons With Spinal Cord Injury (SCI)
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-80 years
Brief Summary
In persons with SCI, because of inherent considerations, the use of mechanical stimulation has not been studied to determine improvement in bone mass. To achieve maximum transmission of the vibration ...
Detailed Description
Experiments will be performed in 12 persons with SCI and 10 healthy able-bodied to optimize the methodology for transmission of the mechanical impulse to the lower extremities in persons with SCI. Thi...
Eligibility Criteria
Inclusion
- Chronic spinal cord injury or healthy able-bodied
- 18+ years of age
Exclusion
- Severe underlying chronic illness (cardiac, pulmonary, gastrointestinal, etc.)
- Flexion contractures of the lower extremities
- Femur or tibia fracture or history of extensive bone trauma
- History of prior bone disease
- Post-menopausal women
- Renal disease (creatinine clearance \< 40 ml/min)
- Endocrine disorders known to be associated with osteoporosis (hyperthyroidism, hypercortisolism, hypogonadism)
- Alcoholism
- Seizure disorders
- All pressure ulcers of the sacral/pelvic region, lower extremities, and heels
- Pacemakers, implanted cardiac defibrillators, or any other electrical cardiac device
- Implanted rods placed between 2 or more vertebral segments
- Pregnant women (pregnancy test will be administered when applicable)
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00882843
Start Date
September 1 2006
End Date
February 1 2010
Last Update
June 25 2012
Active Locations (1)
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1
VA Medical Center, Bronx
The Bronx, New York, United States, 10468