Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury
The purpose of this research study is to determine the effect of mechanical vibrations on bones of persons with spinal cord injury.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Effect of Using Low-magnitude High Frequency Mechanical Stimulation of Bone in Persons With Subacute SCI|
- The main objective of this pilot study is to determine an effect of mechanical stimulation to reduce loss of bone mass and preserve bone architecture of the stimulated tibia. [ Time Frame: After 6 months of Mechanical Stimulation Vibration Plate ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
The subjects will undergo mechanical intervention in the seated position, 5 sessions a week, each session lasting 20 minutes for 6 months. All footwear will be removed, but they may wear socks or be barefoot. Only the right leg will be vibrated and the left leg will serve as a control. The frequency and force of the vibrations will be approximately 35Hz and 0.3g.
In additional load of 50lbs will be added to both legs by using an extra wide strap equipped with bungee cords. The vibrations will only be applied to the right leg even though both legs will be loaded. Vibrations will be eliminated from the left leg using a bridge over the vibrating plate. In order to eliminate the height discrepancy between the sides caused by the addition of the bridge, a spacer will be placed between the foot and the vibrating plate on the stimulated side. Training sessions will be recorded directly on the vibrating plate and must achieve a compliance of 85%.
Device: Mechanical Stimulation with the Vibration Plate
All subjects will undergo mechanical intervention in the seated position 5 sessions a week, with each session lasting up to 20 minutes in duration for 6 months. Subject participation will involve seven visits to the laboratory. The baseline (BL) visit, subjects will receive instruction on the use of and receive the equipment needed for vibration plate therapy at home. Training sessions will be recorded directly on the vibrating plate and compliance will be assessed during the monthly visits.
Testing will be performed at BL, 1, 3 and 6 months will involve the following: Dual energy X-ray absorptiometry (DXA), Blood Samples, 24 hour Urine and Vitamin D and Calcium Administration. Peripheral Quantitative Computed Tomography (pQCT) will be assessed only at BL and 6 months.
Other Name: MSVP
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886145
|United States, New York|
|VA Medical Center, Bronx|
|Bronx, New York, United States, 10468|
|Principal Investigator:||William Bauman, MD||VA Medical Center, Bronx|