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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00882843
First received: April 16, 2009
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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.


Condition
Spinal Cord Injuries

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Feasibility Study for the Use of Low-magnitude, High Frequency Mechanical Stimulation of Bone in Persons With SCI

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Experiments will be to optimize the methodology for transmission of the mechanical impulse to the lower extremities in persons with SCI. [ Time Frame: one day ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: September 2006
Study Completion Date: February 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Healthy Able bodied Control
Group 2
Spinal Cord Injury

Detailed Description:

Experiments will be performed in 12 persons with SCI and 10 healthy able-bodied to optimize the methodology for transmission of the mechanical impulse to the lower extremities in persons with SCI. This will entail the following combinations:

  1. positional modification (sitting, lying or standing if tolerable);
  2. bracing the knee to prevent flexion/extension;
  3. bracing the legs above and/or below the knee;
  4. supporting the ankle;
  5. tilting the surface (tilt table) to a maximum angle of 45 degrees;
  6. Standing with the assistance of a standing frame if subject can tolerate standing for 5 minute time periods.
  7. increasing the magnitude of the plate acceleration (0.2-0.6g); and
  8. mechanically pressing the legs (ankle and knee joints relatively fixed in position by an orthotic device) against the plate by a spring-loaded method (it is envisioned that a padded belt-like article will be worn around the waist and would be attached with bungee cords (or springs) to each side of the vibrating plate; the maximum force delivered would be equal to 50 lbs or one-third of total body weight, whichever is less).

An accelerometer for the measurement of impulse generation will be placed on the surface of the vibrating plate between the feet; a second will be placed on the shin about 4 inches below the knee (attached with double sided tape and athletic bandage wrap); a third accelerometer will be placed in the mouth as a bite-bar. Measurements would be acquired with combinations of body position, joint/leg fixation, magnitude of plate acceleration ("g" force), and mechanical force pressing the feet against the plate to determine the optimal transmission of impulse.

This study will determine the optimal of the methodology for using the vibrating plate to transmit an impulse in persons with chronic SCI, with the anticipation of its application to increase bone mass in individuals with acute or chronic SCI. It is anticipated that each session will be between 30 and 120 minutes. An individual may voluntarily participate in as many as 5 sessions. The knowledge gained from the first sets of studies will obviate the need to perform less effective methods of mechanical signal transmission in subsequent studies. It is anticipated that once the most effective, as well as clinically applicable, form of mechanical stimulation is identified, it will be performed in most of the subjects. This preliminary study will also provide the information required to determine practical aspects of the length of each session and number of sessions per week in a future intervention trial.

Since this research may have adverse effects on an unborn child and should not be done during pregnancy, we will administer a pregnancy test when appropriate. Subjects will be asked to avoid becoming pregnant and use contraceptives, take precautions against becoming pregnant.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  1. Chronic spinal cord injury or healthy able-bodied
  2. 18+ years of age

Exclusion Criteria:

  1. Severe underlying chronic illness (cardiac, pulmonary, gastrointestinal, etc.)
  2. Flexion contractures of the lower extremities
  3. Femur or tibia fracture or history of extensive bone trauma
  4. History of prior bone disease
  5. Post-menopausal women
  6. Renal disease (creatinine clearance < 40 ml/min)
  7. Endocrine disorders known to be associated with osteoporosis (hyperthyroidism, hypercortisolism, hypogonadism)
  8. Alcoholism
  9. Seizure disorders
  10. All pressure ulcers of the sacral/pelvic region, lower extremities, and heels
  11. Pacemakers, implanted cardiac defibrillators, or any other electrical cardiac device
  12. Implanted rods placed between 2 or more vertebral segments
  13. Pregnant women (pregnancy test will be administered when applicable)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882843

Locations
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
Investigators
Principal Investigator: William Bauman, MD VA Medical Center, Bronx
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00882843     History of Changes
Other Study ID Numbers: B4162C-9
Study First Received: April 16, 2009
Last Updated: June 21, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Vibrating plate
Mechanical Stimulation
Osteoporosis

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014