3D Hand Orthosis Trial

Starting soon · Not applicable

Conditions studied: Hand Injuries and Disorders, Neurological Conditions, Neuromuscular Diseases (NMD), Musculoskeletal Conditions (e.g., Tendinitis, Capsulitis)

In brief

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.

Key facts

Study ID

NCT07633821

Run by

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

People needed

100

Starts

2026-06-01

Expected to finish

2030-09-01

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Amsterdam UMC, location AMC — Amsterdam, North Holland, Netherlands

Full record on ClinicalTrials.gov

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