Spinal Cord InjuriesNCT00886145
Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury
A study testing Vibration: Right Leg and No Vibration: Left Leg. in people with Spinal Cord Injuries, run by William A. Bauman, M.D. at 1 site in United States.
Trial summary
The purpose of this research study is to determine the effect of mechanical vibrations on bones of persons with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Vibration: Right Leg and No Vibration: Left Leg.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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);
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Using Low-magnitude High Frequency Mechanical Stimulation of Bone in Persons With Subacute SCI
The purpose of this research study is to determine the effect of mechanical vibrations on bones of persons with spinal cord injury.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Vibration: Right Leg and No Vibration: Left Leg.
- Keywords
- Spinal Cord Injuries, Mechanical Stimulation, Vibration Plate
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration: Right Leg and No Vibration: Left Leg.Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Vibration and No Vibration | Other | Vibration: Right Leg and No Vibration: Left Leg. Receives: Device: Vibration: Right Leg and No Vibration: Left Leg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The Percent Change in vBMD from Baseline to 6 months after Mechanical Stimulation Vibration Therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- William A. Bauman, M.D.
- Sponsor type
- US federal agency
- Collaborators
- Kessler Foundation
- Responsible party
- Sponsor-investigator, William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center
- Investigators
- William Bauman, MD, Principal investigator, VA Medical Center, Bronx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886145
- Sponsor's protocol ID
- B4162C-10
- Status last verified
- Feb 2016
- First submitted
- 21 Apr 2009
- Last updated
- 28 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Low-magnitude High Frequency Mechanical Stimulation of Bone in Persons With Subacute SCI
- ClinicalTrials.gov ID
- NCT00886145
- Acronym / sponsor ID
- B4162C-10
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, Mechanical Stimulation, Vibration Plate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- William A. Bauman, M.D.US federal agency
- Collaborators
- Kessler Foundation
- Study start
- Jun 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Apr 2009 (estimated)
- Results
- Posted 28 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibration and No Vibration | Other | Device: Vibration: Right Leg and No Vibration: Left Leg.Vibration: Right Leg and No Vibration: Left Leg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Vibration and No Vibration |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Spinal Cord Damage Research CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Bauman, MD principal investigator
VA Medical Center, Bronx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration: Right Leg and No Vibration: Left Leg. in people with Spinal Cord Injuries, run by William A. Bauman, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016; AzTrials last refreshed its copy on 6 Nov 2026.