Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury
|ClinicalTrials.gov Identifier: NCT00886145|
Recruitment Status : Completed
First Posted : April 22, 2009
Results First Posted : April 28, 2016
Last Update Posted : April 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Device: Vibration: Right Leg and No Vibration: Left Leg.||Not Applicable|
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.
In persons with subacute spinal cord injury:
- To determine differences in bone mineral mass and parameters of bone structural integrity of the stimulated tibia versus the unstimulated tibia.
- To determine changes in the metabolic markers of bone resorption and formation in persons with subacute spinal cord injury.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Using Low-magnitude High Frequency Mechanical Stimulation of Bone in Persons With Subacute SCI|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||December 2012|
Vibration and No Vibration
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 [ Time Frame: The Percent Change in vBMD from Baseline to 6 months after Mechanical Stimulation Vibration Therapy ]Volumetric Bone Mineral Density of the Right and Left Distal Tibia as Determined by Peripheral Quantitative Computed Tomography
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886145
|United States, New York|
|VA Medical Center, Bronx|
|Bronx, New York, United States, 10468|
|Principal Investigator:||William Bauman, MD||VA Medical Center, Bronx|