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14th Triennial Congress of the International Federation of Societies for Surgery of the Hand (IFSSH), 11th Triennial Congress of the International Federation of Societies for Hand Therapy (IFSHT)

17.06. - 21.06.2019, Berlin

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Developed Orthosis Evaluation Protocol: focus on users and tasks

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  • presenting/speaker Daniela Goia - São Paulo University, Bioengineering Interunit Postgraduate Program, Health Science Department, Ribeirão Preto, Brazil
  • Carlos Fortulan - São Paulo University, São Carlos Engineering School, São Carlos, Brazil
  • Ellen Masalskas - São Paulo University, Bioengineering Interunit Postgraduate Program, Ribeirão Preto, Brazil
  • Flávia Giglio - São Paulo University, Heath Science Department, Ribeirão Preto, Brazil
  • Valeria Elui - São Paulo University, Bioengineering Interunit Postgraduate Program, Health Science Department, Ribeirão Preto, Brazil

International Federation of Societies for Surgery of the Hand. International Federation of Societies for Hand Therapy. 14th Triennial Congress of the International Federation of Societies for Surgery of the Hand (IFSSH), 11th Triennial Congress of the International Federation of Societies for Hand Therapy (IFSHT), 11th Triennial Congress of the International Federation of Societies for Hand Therapy (IFSHT). Berlin, 17.-21.06.2019. Düsseldorf: German Medical Science GMS Publishing House; 2020. DocIFSHT19-1279

doi: 10.3205/19ifssh1532, urn:nbn:de:0183-19ifssh15320

Published: February 6, 2020

© 2020 Goia et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.

Outline

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Objective: Product usability definition is "the extent to which a product can be used by specified users to achive specified goals with effectiveness, efficiency and satisfaction in a specified context of use". According to Human Activity of Assistive Techology (HAAT) the device development depend on respect of all members expertises (researchers, clients, therapists), with interactive proccess and during the course of development, changes are made according to the users functional needs (prototype optimization). Device evaluation depends on quantitative and qualitative measures. Purpose describes a Protocol to optimize and test the use of kinetic ulnar deviation orthosis based on HAAT model.

Materials and Methods: Product development methodologies survey focusing on concept evolution, prototype optimization and its use was made. After each design modifications test are done. Was quasi-experimental study with single subject approach. All phases used the same assessment: clinical conditions, Think Aloud method, Functional Tests, DASH, Quebec User Evaluation of Satisfaction with Assistive Technology, Patient-Specific Functional Scale, Dinamometry, Goniometry and patient opinion.

Results: Protocol: 1st phase: Modified heuristic evaluation 3-5 evaluators used to identify prototype capabilities and weaknesses. Prototype optimization is made using computational bench tests: finite elements; functional simulation and test in the researcher's hands. 2nd: Prototype evaluation in clinical setting (N= 5-7) looking at deformity correction and functional status making changes in the design and retesting. 3rd: Orthosis use validation, (N= 5-10) 30-60 days home use, minimum of 2 hours a day, made telephone contacts and monthly returns. If necessary the design is modified based on user's evaluations. 4th: usability test (N=30+) home use of 90 to 120 days with a minimum of 4 hours a day and use of telephone contacts and monthly returns.

Conclusions: The protocol made possible the optimization, test of use and orthosis usability study.