Hand orthoses are often provided to improve performance of activities of daily life (ADL) in patients with chronic hand conditions, but the manufacturing process of conventional custom-made hand orthoses is a time-consuming and labor-intensive process. Even though three dimensional (3D)-printing of orthoses is a rapidly growing area that can facilitate the manufacturing process of hand orthoses, evidence on the effectiveness and efficiency of 3D-printed orthoses in chronic hand conditions is lacking. The objective of this study is to assess the preliminary effectiveness of 3D-printed orthoses for permanent use on performance of ADL, satisfaction, quality of life, and efficiency in persons with chronic hand conditions compared to conventional custom-fabricated orthoses.
The study population includes adults (n=20), aged 18 years or older, with a variety of chronic conditions that require a hand orthosis (wrist, wrist-thumb or thumb orthosis) for performing daily activities. Participants will receive a 3D-printed orthosis (wrist, wrist-thumb or thumb orthosis), provided by OIM Orthopedie (The Netherlands), which will be compared to the conventional orthosis patients are currently using. Study outcomes will be assessed two weeks prior to the intervention (T1), and at baseline (T2) for the conventional orthosis, and at one month (T3) and four months (T4) follow up for the 3D-printed orthosis. The main study outcome is change from baseline (mean T1/T2) in performance of ADL on the a custom short form of the Dutch-Flemish Patient-Reported Outcomes Measurement Information System – Upper extremity (DF-PROMIS-UE) at four months follow up. Secondary outcomes include, general hand function, assessed with the Michigan Hand (Outcomes) Questionnaire – Dutch language version (MHQ-DLV), satisfaction with the orthosis, assessed with the Dutch Client Satisfaction with Device (D-CSD) and Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST), usability, assessed with an in-house questionnaire to evaluate the attainment of personal goals regarding the orthosis, and quality of life assessed with the EuroQoL 5-Dimension 5-Level (EQ-5F-5L)). Efficiency will be evaluated by assessing costs and production time of the conventional and 3D-printed orthoses. Experiences regarding the manufacturing process will be obtained from patients and orthotists (time window of the 3D-intervention, satisfaction with the treatment process, number of visits).