View Clinical Trial (Medical Research Study)
Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury - NCT00886145-10468(Clinical Trial 288346)
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| City: |
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Bronx |
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State:
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NY |
| Zip Code: |
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10468 |
| Conditions: |
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Spinal Cord Injuries |
| Purpose: |
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The purpose of this research study is to determine the effect of mechanical vibrations on
bones of persons with spinal cord injury.
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| Study summary: |
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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.
OBJECTIVES
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. |
| Criteria: |
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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 |
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| Study is available at: |
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VA Medical Center, Bronx
Bronx, NY 10468
United States
Primary Contact:
Pierre K Asselin
Email: Pierre.Asselin@va.gov
Phone: 718-584-9000
Secondary Contact:
Pierre K Asselin
Email: Pierre.Asselin@va.gov
Phone: (718) 584-9000 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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