Smart Adaptive Socket to Improve Fit and Relieve Pain in Wounded Warriors
Technical Report,30 Sep 2015,30 Sep 2019
Orthocare Innovations LLC Edmonds United States
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A clinical trial of the Smart Adaptive Socket System SASS was initiated during the research period, following IRB approval. While clinical data collection is ongoing using other funding, to date seven eligible male veteran subjects with unilateral transtibial amputations were recruited from James A. Haley VA Hospital. The SASS prostheses were fabricated from duplicated models of the subjects current prostheses socket system STD. Subjects wore the SASS system and the STD system for three days each. Activity data was collected for each subject using the Step Watch Activity Monitor SWAM and Prosthesis Evaluation Questionnaires PEQ were completed for each condition. Preliminary results from five completed clinical trials demonstrate that for the majority of users, SASS improved mobility and satisfaction over their STD device in terms of daily step count and step rate and PEQ data, although these preliminary results were statistically insignificant. One subject experienced a technical issue with his SASS system resulting in outlying data that should be excluded from the analysis to improve significance and increase the correlations observed. The development and enhancement of the SASS is clinically applicable to enable patients to easily adapt their socket fit to accommodate volume fluctuation. This will likely improve socket fit, prevent skin breakdown, and improve patient outcomes. Further investigation of this technology is needed to determine treatment efficacy.
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