Feasibility Study for the Use of Low-magnitude, High Frequency Mechanical Stimulation of Bone in Persons With Spinal Cord Injury (SCI)

Completed

Conditions studied: Spinal Cord Injuries

In brief

In persons with SCI, because of inherent considerations, the use of mechanical stimulation has not been studied to determine improvement in bone mass. To achieve maximum transmission of the vibration from a vibrating plate to the lower body, the legs must be extended and the feet firmly placed against the surface plate of the device. Thus, these logistical considerations must be addressed to perform this mechanical intervention in persons with SCI. In those with complete or almost complete motor injury, there is lack of musculoskeletal function below the level of the lesion, which would prevent rigid straight leg extension and pressing one's feet against a surface, regardless of the angle of tilt that would permit adequate transmission of impulse in an able-bodied individual (preliminary data). However, in one subject with SCI, there was measurable, albeit low level, transmission of vibration with increasing angles of tilt (preliminary data). Because of the ability to transmit some signal in an individual with complete SCI, the possibility exists that with forms or mechanical support/manipulation, greater signal transmission may be possible. The study will be able to determine the best angle to transmit mechanical vibration through the lower body of SCI patients.

Key facts

Study ID

NCT00882843

Run by

US Department of Veterans Affairs

People needed

22

Starts

2006-09-01

Expected to finish

2010-02-01

Last updated by the study team

2012-06-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Chronic spinal cord injury or healthy able-bodied
• 18+ years of age

You may not qualify if…

• Severe underlying chronic illness (cardiac, pulmonary, gastrointestinal, etc.)
• Flexion contractures of the lower extremities
• Femur or tibia fracture or history of extensive bone trauma
• History of prior bone disease
• Post-menopausal women
• Renal disease (creatinine clearance < 40 ml/min)
• Endocrine disorders known to be associated with osteoporosis (hyperthyroidism, hypercortisolism, hypogonadism)
• Alcoholism
• Seizure disorders
• All pressure ulcers of the sacral/pelvic region, lower extremities, and heels
• Pacemakers, implanted cardiac defibrillators, or any other electrical cardiac device
• Implanted rods placed between 2 or more vertebral segments
• Pregnant women (pregnancy test will be administered when applicable)

Where it is running

• VA Medical Center, Bronx — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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