Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury

Study Overview
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Brief Summary
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The purpose of this research study is to determine the effect of mechanical vibrations on bones of persons with spinal cord injury.

Detailed Description
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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.

Official Title
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Effect of Using Low-magnitude High Frequency Mechanical Stimulation of Bone in Persons With Subacute SCI

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: Vibration: Right Leg and No Vibration: Left Leg.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vibration and No Vibration<br>Vibration: Right Leg and No Vibration: Left Leg. | Device: Vibration: Right Leg and No Vibration: Left Leg.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The Percent Change in vBMD from Baseline to 6 months after Mechanical Stimulation Vibration Therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injuries, Mechanical Stimulation, Vibration Plate