Back to resultsEffect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vibration: Right Leg and No Vibration: Left Leg.
Sponsored by
About this trial
This is an interventional prevention trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, Mechanical Stimulation, Vibration Plate
Eligibility Criteria
Inclusion Criteria:
- Males;
- Age 18-65;
- Non-ambulatory SCI, with ASIA level A or B (ASIA A or B at the time of enrollment);
- Neurological level of injury C3-T10;
- 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:
- Osteoporosis or low bone mass as determined by medical history or DXA at the baseline visit;
- Pressure ulcer that may be exacerbated by the experimental procedure;
- Fracture of the lower extremity within the past 5 years;
- Active heterotopic ossification (HO);
- History of metabolic bone disease;
- Knee replacement(s);
- Metal hardware in the lower extremities;
- Bisphosphonate administration;
- Severe underlying chronic illness (cardiac, pulmonary, gastrointestinal, etc.);
- Renal disease (creatinine clearance < 40 mL/min);
- 25(OH)D levels <30ng/ml;
- Endocrine disorders known to be associated with osteoporosis (hyperthyroidism, hypercortisolism, and/or hypogonadism);
- Alcoholism;
- Seizure disorders;
- History of kidney stones; and
- Compliance 85% for every month up to the 4-month time-point
Sites / Locations
- VA Medical Center, Bronx
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Vibration and No Vibration
Arm Description
Vibration: Right Leg and No Vibration: Left Leg.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00886145
First Posted
April 21, 2009
Last Updated
March 28, 2016
Sponsor
William A. Bauman, M.D.
Collaborators
Kessler Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00886145
Brief Title
Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury
Official Title
Effect of Using Low-magnitude High Frequency Mechanical Stimulation of Bone in Persons With Subacute SCI
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
William A. Bauman, M.D.
Collaborators
Kessler Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to determine the effect of mechanical vibrations on bones of persons with spinal cord injury.
Detailed Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Injuries, Mechanical Stimulation, Vibration Plate
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vibration and No Vibration
Arm Type
Other
Arm Description
Vibration: Right Leg and No Vibration: Left Leg.
Intervention Type
Device
Intervention Name(s)
Vibration: Right Leg and No Vibration: Left Leg.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males;
Age 18-65;
Non-ambulatory SCI, with ASIA level A or B (ASIA A or B at the time of enrollment);
Neurological level of injury C3-T10;
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:
Osteoporosis or low bone mass as determined by medical history or DXA at the baseline visit;
Pressure ulcer that may be exacerbated by the experimental procedure;
Fracture of the lower extremity within the past 5 years;
Active heterotopic ossification (HO);
History of metabolic bone disease;
Knee replacement(s);
Metal hardware in the lower extremities;
Bisphosphonate administration;
Severe underlying chronic illness (cardiac, pulmonary, gastrointestinal, etc.);
Renal disease (creatinine clearance < 40 mL/min);
25(OH)D levels <30ng/ml;
Endocrine disorders known to be associated with osteoporosis (hyperthyroidism, hypercortisolism, and/or hypogonadism);
Alcoholism;
Seizure disorders;
History of kidney stones; and
Compliance 85% for every month up to the 4-month time-point
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Bauman, MD
Organizational Affiliation
VA Medical Center, Bronx
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Bronx
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.scirc.org/
Description
Spinal Cord Damage Research Center
Learn more about this trial
Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury
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