An interventional study of Vibration: Right Leg and No Vibration: Left Leg. in Spinal Cord Injuries, sponsored by William A. Bauman, M.D.. Completed at 1 site in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-04-28.
Sponsored by William A. Bauman, M.D. · Not applicable, Interventional, and Prevention
The purpose of this research study is to determine the effect of mechanical vibrations on bones of persons with spinal cord injury.
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:
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 1 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →This is the only study on the registry with William A. Bauman, M.D. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months
Volumetric Bone Mineral Density of the Right and Left Distal Tibia as Determined by Peripheral Quantitative Computed Tomography
Time frame: The Percent Change in vBMD from Baseline to 6 months after Mechanical Stimulation Vibration Therapy
| Milestone | Vibration: Right Leg and No Vibration: Left Leg |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
Volumetric Bone Mineral Density of the Right and Left Distal Tibia as Determined by Peripheral Quantitative Computed Tomography
| Percent Change | Vibration- Right Leg | No Vibration- Left Leg |
|---|---|---|
| Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months | -11 | -5.7 |
Collected over 1.5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vibration- Right Leg: | — | 1/1 (100%) | 0/1 (0%) |
| No Vibration-left Leg: | — | 1/1 (100%) | 0/1 (0%) |
| Event | Vibration- Right Leg: | No Vibration-left Leg: |
|---|---|---|
| Autonomic DysreflexiaNervous system disorders | 1/1 | 1/1 |
| Age, Categorical(Participants) | Vibration- Right Leg and No Vibration-left Leg |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Vibration- Right Leg and No Vibration-left Leg |
|---|---|
| Female | 0 |
| Male | 1 |
Plan to share: No
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