Feasibility Study for the Use of Low-magnitude, High Frequency Mechanical Stimulation of Bone in Persons With Spinal Cord Injury (SCI)
Spinal Cord Injuries
|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|
- 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 ]
|Study Start Date:||September 2006|
|Study Completion Date:||February 2010|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Healthy Able bodied Control
Spinal Cord Injury
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:
- positional modification (sitting, lying or standing if tolerable);
- bracing the knee to prevent flexion/extension;
- bracing the legs above and/or below the knee;
- supporting the ankle;
- tilting the surface (tilt table) to a maximum angle of 45 degrees;
- Standing with the assistance of a standing frame if subject can tolerate standing for 5 minute time periods.
- increasing the magnitude of the plate acceleration (0.2-0.6g); and
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882843
|United States, New York|
|VA Medical Center, Bronx|
|Bronx, New York, United States, 10468|
|Principal Investigator:||William Bauman, MD||VA Medical Center, Bronx|