Amsterdam UMC location University of Amsterdam, Department of Rehabilitation Medicine, Meibergdreef 9, Amsterdam, The Netherlands
Amsterdam Movement Sciences, Rehabilitation & Development, Amsterdam, The Netherlands.
BMJ Open. 2023 Apr 6;13(4):e069424. doi: 10.1136/bmjopen-2022-069424.
Hand orthoses are often provided to improve performance of activities of daily life (ADL). Yet, the manufacturing process of conventional custom-fabricated hand orthoses is a time-consuming and labour-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, costs and production time of 3D-printed orthoses in chronic hand conditions is scarce. This study aims to assess (1) the preliminary effectiveness of 3D-printed orthoses compared with conventionally custom-fabricated orthoses in persons with chronic hand conditions, (2) production time and costs of both orthoses and (3) experiences of the participants and orthotists with the manufacturing process of the 3D-printed orthosis.
In this prospective non-randomised interventional feasibility study, 20 adults with various chronic hand conditions using a conventional thumb, wrist or wrist-thumb orthosis will be provided with a 3D-printed corresponding type of orthosis. Assessments will be done 2 weeks prior to the intervention and at baseline for the conventional orthosis, and at 1 month and 4 months follow-up for the 3D-printed orthosis. The primary outcome is change from baseline in ADL performance (custom short form Dutch-Flemish Patient-Reported Outcomes Measurement Information System-Upper Extremity; ADL domain Michigan Hand Outcomes Questionnaire Dutch language version (MHQ-DLV)) at 4 months follow-up. Secondary outcomes include general hand function (MHQ-DLV), satisfaction with the orthosis (Dutch Client Satisfaction with Device; Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology), usability (in-house questionnaire) and quality of life (EuroQoL 5-Dimension 5-Level). Costs and production time of the conventional and 3D-printed orthoses will be prospectively recorded. Experiences regarding the manufacturing process will be obtained from participants and orthotists (in-house questionnaire).
The Medical Ethics Committee of the Amsterdam UMC, Academic Medical Centre, has waived the requirement for ethical review of this study. Results will be disseminated through peer-reviewed journals, scientific conferences, and media aimed at a broad audience including patients.
NCT05320211.
手部矫形器常用于提高日常生活活动（ADL）的表现。然而，传统定制手部矫形器的制造过程是一个耗时且劳动密集型的过程。尽管 3D 打印矫形器是一个快速发展的领域，可以促进手部矫形器的制造过程，但在慢性手部疾病中，3D 打印矫形器的有效性、成本和生产时间的证据仍然很少。本研究旨在评估：（1）3D 打印矫形器与慢性手部疾病患者的传统定制矫形器相比的初步有效性；（2）两种矫形器的生产时间和成本；（3）参与者和矫形器技师对 3D 打印矫形器制造过程的体验。
在这项前瞻性非随机干预可行性研究中，20 名患有各种慢性手部疾病的成年人将使用传统拇指、手腕或手腕拇指矫形器，他们将获得相应类型的 3D 打印矫形器。将在干预前 2 周和基线时对传统矫形器进行评估，并在 1 个月和 4 个月时对 3D 打印矫形器进行随访。主要结果是 4 个月随访时 ADL 表现（ADL 领域密歇根手部结果问卷荷兰语版本（MHQ-DLV））的基线变化。次要结果包括一般手部功能（MHQ-DLV）、对矫形器的满意度（荷兰患者对设备满意度量表；荷兰版魁北克用户对辅助技术满意度量表）、可用性（内部问卷）和生活质量（EuroQoL 5 维度 5 水平）。将前瞻性地记录传统和 3D 打印矫形器的成本和生产时间。参与者和矫形器技师将从制造过程中获得经验（内部问卷）。
阿姆斯特丹 UMC，学术医学中心的医学伦理委员会已放弃对本研究进行伦理审查的要求。研究结果将通过同行评议的期刊、科学会议以及面向广泛受众（包括患者）的媒体进行传播。
NCT05320211。
