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PRELIMINARY CLINICAL STUDY OF SMART ORTHOTIC FOR AIS



Abstract

Brace correction based upon mechanical action requires appropriate interface pressure between the body and the brace.

A smart orthotic was developed to record how much time (quantity) a brace was used, how well (quality) it was used and maintain the interface pressure to the prescribed level. Six subjects were recruited and they all used Boston style braces. Each subject used the system for two weeks without the force maintenance system activated to serve as the control period, and the remaining two weeks with the force maintenance system activated. During the automatic feedback mode, the pressure maintenance system was activated only during the daytime (8:00–22:00hrs) to avoid disturbing the patients during sleep. The subject could either return the system to us after one month or continue to use the system until the next clinic.

The time that the pressure level was in the target level range during the study period was increased from 53 +/− 9% to 68 +/− 14% with the feedback activated. The average brace wear time for the study period was 72 +/− 15% (12.6hr/day) of the prescribed time (17.5 +/− 3.8 hours). The curve severity of all subjects on the following clinical visit was the same (within measurement error) as the first visit (32 +/− 5 vs 31 +/− 5 degrees). Compliance was not affected when wearing the monitor.

The smart orthotic was able to improve the efficiency of a conventional brace by maintaining the prescribed interface pressure automatically. This proposed work helps brace candidates wear their braces more effectively and gets the most benefit from the brace treatment. As a result, all participated subjects maintained their Cobb angle within ± two degrees during the study period.

Correspondence should be addressed to: Cynthia Vezina, Communications Manager, COA, 4150-360 Ste. Catherine St. West, Westmount, QC H3Z 2Y5, Canada