NCT00886145

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

April 28, 2016

Completed
Last Updated

April 28, 2016

Status Verified

February 1, 2016

Enrollment Period

2.9 years

First QC Date

April 21, 2009

Results QC Date

February 24, 2016

Last Update Submit

March 28, 2016

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord InjuriesMechanical StimulationVibration Plate

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Vibration and No Vibration

OTHER

Vibration: Right Leg and No Vibration: Left Leg.

Device: Vibration: Right Leg and No Vibration: Left Leg.

Interventions

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.

Vibration and No Vibration

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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);
  • (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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

Related Links

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Limitations and Caveats

Subject recruitment was untenable due to the physiological and psychological healing necessary during the sub-acute phase of spinal cord injury.

Results Point of Contact

Title
William A. Bauman
Organization
James J. Peters VA Medical Center
william.bauman@va.gov
718-584-9000

Study Officials

  • William Bauman, MD

    VA Medical Center, Bronx

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 22, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2012

Study Completion

December 1, 2012

Last Updated

April 28, 2016

Results First Posted

April 28, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)