Spinal Cord Injuries
Conditions
Keywords
Spinal Cord Injuries, Mechanical Stimulation, Vibration Plate
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: 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.
Interventions
DEVICEVibration: 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.
Sponsors
Kessler Foundation
William A. Bauman, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vibration- Right Leg and No Vibration-left 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.
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. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Vibration- Right Leg and No Vibration-left Leg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 1 / 1 | 1 / 1 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vibration- Right Leg | Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months | -11 Percent Change |
| No Vibration- Left Leg | Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months | -5.7 Percent Change |