Preliminary effectiveness of 3D-printed orthoses in chronic hand conditions: study protocol for a non-randomised interventional feasibility study
Bibliographic record
Abstract
INTRODUCTION: 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. METHODS AND ANALYSIS: 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). ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT05320211.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.042 | 0.039 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.010 | 0.005 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.008 | 0.005 |
| Insufficient payload (model declined to judge) | 0.053 | 0.012 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".