3D Hand Orthosis Trial

Официальное название

Cost-effectiveness of 3D-printed Hand Orthoses for Activities of Daily Living in Chronic Hand Conditions

Обзор

In people with chronic hand conditions, hand orthoses are frequently prescribed to improve performance in activities of daily living (ADL). Conventional hand orthoses are custom-made on a plaster cast of the hand, a process that is time-consuming and labor-intensive. It has been demonstrated that the production time of manufacturing hand orthoses can be reduced by using 3-dimensional scanning and printing (i.e. 3D-printed hand orthosis), offering a promising cost-effective alternative to conventional hand orthoses. The current study builds on a previously conducted feasibility study, which demonstrated comparable effects of 3D-printed and conventional hand orthoses on ADL performance, hand function, and quality of life in people with chronic hand conditions. User satisfaction and production time favored the 3D-printed orthoses. However, to date only small and self-controlled studies have investigated the effects of 3D-printed versus conventional hand orthoses for permanent use on ADL performance and orthosis satisfaction in chronic hand conditions. Evidence from randomized controlled trials and data on the cost-effectiveness are lacking. The aims of this study are: 1. To determine whether treatment with 3D-printed hand orthoses is non-inferior compared to treatment with conventional hand orthoses in terms of ADL performance, hand function, pain, quality of life and functional status in individuals with chronic hand conditions. 2. To assess whether treatment with 3D-printed hand orthoses results in greater patient satisfaction compared to treatment with conventional hand orthoses. 3. To assess the cost-effectiveness of treatment with 3D-printed hand orthoses compared to treatment with conventional hand orthoses.

Вмешательства

• Устройство 3D-printed hand orthosis (intervention)
  3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional orthoses (control)
• Устройство Conventional hand orthosis (control)
  3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional hand orthoses (control)

Первичные конечные точки

• Change from baseline to 4 months follow-up in performance of Activities of Daily Living (ADL) with the DF-PROMIS-UE (custom short form of the Dutch-Flemish Patients-Reported Outcomes Measurement Information System - Upper Extremity) [Срок оценки: At screening and baseline (i.e. 2 weeks after the screening). And 1, 4, 8 and 12 months after delivery of the hand orthosis.]

Вторичные конечные точки (10)

• Change from baseline to 4 months follow-up in overall hand function and pain on the MHQ-DLV (Michigan Hand Questionnaire-Dutch Language version) [Срок оценки: At screening and baseline (i.e. 2 weeks after the screening). And 1, 4, 8 and 12 months after delivery of the hand orthosis.]
• Orthosis satisfaction assessed with the Dutch version of the Client Satisfaction with Device (D-CSD) module of the Orthotics and Prosthetics User's Survey (OPUS) at 4 months follow-up [Срок оценки: At screening and baseline (i.e. 2 weeks after the screening). And 1, 4, 8 and 12 months after delivery of the hand orthosis.]
• Orthosis satisfaction assessed with the Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST) at 4 months follow-up [Срок оценки: The device component of the D-QUEST will be administered at screening and baseline (i.e. 2 weeks after the screening). The device and service components will be administered at 1, 4, 8 and 12 months after delivery of the hand orthosis.]
• Change from baseline to 4 months follow-up in quality of life on the EuroQol 5-dimension 5-level (EQ-5D-5L) [Срок оценки: At screening and baseline (i.e. 2 weeks after the screening). And 1, 4, 8 and 12 months after delivery of the hand orthosis.]
• Change from baseline to 4 months follow-up in functional status assessed using the Patient Specific Complaints instrument (PSC) [Срок оценки: The activities are determined and scored at the screening. At baseline (i.e. 2 weeks after the screening), and 1, 4, 8 and 12 months after delivery of the hand orthosis, the activities are scored again on the 0-10 scale.]
• Experiences with the given interventions (patient) [Срок оценки: At 1 month after delivery of the orthosis.]
• Health care and societal costs assessed with a cost questionnaire [Срок оценки: At 1, 4, 8 and 12 months follow-up.]
• Production time of the orthosis (in minutes) [Срок оценки: From the date of fitting of the hand orthosis until the date of delivery of the orthosis, assessed up to 1 month.]
• Production costs of the orthosis (in euro) [Срок оценки: From the date of fitting of the hand orthosis until the date of delivery of the orthosis, assessed up to 1 month.]
• Experiences with development of the orthoses (orthotists from OIM Orthopedie) [Срок оценки: From the date of fitting of the hand orthosis until the date of delivery of the orthosis, assessed up to 1 month.]

Критерии участия

Критерии включения

• Diagnosed with a chronic, stable hand condition due to a neurological disorder, musculoskeletal disorder, neuromuscular disease or injury;
• Minimum age of 18 years;
• Indicated for a first or repeat prescription of a circular thumb, wrist or wrist-thumb orthosis for permanent use for improving ADL performance.

Критерии исключения

• Indicated for an orthosis for a non-functional hand;
• Insufficient mastery of the Dutch language.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Amsterdam UMC, location AMC — Amsterdam

Публикации

• Oud T, Nollet F, Brehm MA. Reliability of 2 self-report questionnaires assessing performance of activities of daily living in chronic hand orthotic users. Prosthet Orthot Int. 2026 Jun 1;50(3):321-329. doi: 10.1097/PXR.0000000000000460. Epub 2025 Jun 5. PMID 40472141
• Oud T, Tuijtelaars J, Schenk J, Nollet F, Brehm MA. Validity and reliability of the Dutch translation of the OPUS' client satisfaction with device module in chronic users of hand orthoses. Health Qual Life Outcomes. 2023 Aug 21;21(1):93. doi: 10.1186/s12955-023-02181-3. PMID 37605151
• Oud T, Kerkum Y, de Groot P, Gijsbers H, Nollet F, Brehm MA. Production Time and User Satisfaction of 3-Dimensional Printed Orthoses For Chronic Hand Conditions Compared With Conventional Orthoses: A Prospective Case Series. J Rehabil Med Clin Commun. 2021 Feb 12;4:1000048. doi: 10.2340/20030711-1000048. eCollection 2021. PMID 33884150
• Oud T, Bogaards JA, Nollet F, Brehm MA. Preliminary effectiveness and production time and costs of three-dimensional printed orthoses in chronic hand conditions: an interventional feasibility study. J Rehabil Med. 2024 May 14;56:jrm39946. doi: 10.2340/jrm.v56.39946. PMID 38742877
• Oud T, Tuijtelaars J, Bogaards H, Nollet F, Brehm MA. Preliminary effectiveness of 3D-printed orthoses in chronic hand conditions: study protocol for a non-randomised interventional feasibility study. BMJ Open. 2023 Apr 6;13(4):e069424. doi: 10.1136/bmjopen-2022-069424. PMID 37024252

Идентификаторы

NCT: NCT07633821 · 10310012410005 · 2025.1123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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