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

NCT00882843 | Completed

• 1 other identifier: B4162C-9
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Keywords

Vibrating plate; Mechanical Stimulation; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Experiments will be to optimize the methodology for transmission of the mechanical impulse to the lower extremities in persons with SCI.

  one day

Study Arms (2)

Group 1

Healthy Able bodied Control

Group 2

Spinal Cord Injury

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ten ambulatory able-bodied and Twelve non-ambulatory subjects with SCI will be enrolled to participate

You may qualify if:

• Chronic spinal cord injury or healthy able-bodied
• + 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)

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Osteoporosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• William Bauman, MD

  VA Medical Center, Bronx

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 17, 2009
• Study Start: September 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: February 1, 2010
• Last Updated: June 25, 2012

Record last verified: 2012-06

Locations

US (1)