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NCT Number: NCT07633821

3D Hand Orthosis Trial

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.

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Key information

Conditions

Hand Injuries and Disorders Behavior Bursitis Disease Hand Injuries Health Behavior Joint Diseases Muscular Diseases Musculoskeletal Conditions (e.g., Tendinitis, Capsulitis) Musculoskeletal Diseases Nervous System Diseases Neurological Conditions Neuromuscular Diseases Neuromuscular Diseases (NMD) Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Satisfaction Tendinopathy Tendon Injuries Treatment Adherence and Compliance Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

3D-printed hand orthosis (intervention)

Device

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

Conventional hand orthosis (control)

Device

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

Primary outcomes

  1. 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)

    Time frame: At screening and baseline (i.e. 2 weeks after the screening). And 1, 4, 8 and 12 months after delivery of the hand orthosis.

    The short form DF-PROMIS-UE contains 25 items from the DF-PROMIS-UE 46-item bank. Patients will rate how easily they can perform each activity on a 5-point scale, ranging from "without any difficulty" (score 4 or 5) to "unable to do" (score 1). For each activity, the question was added whether participants use their orthosis for that specific activity. The total score will be expressed as a T-score. The short form DF-PROMIS-UE has previously been established as a reliable instrument for assessing ADL performance in chronic hand orthotic users.

Secondary outcomes

  1. Change from baseline to 4 months follow-up in overall hand function and pain on the MHQ-DLV (Michigan Hand Questionnaire-Dutch Language version)

    Time frame: At screening and baseline (i.e. 2 weeks after the screening). And 1, 4, 8 and 12 months after delivery of the hand orthosis.

    This study uses two domains of the MHQ-DLV, overall hand function and pain. The domain overall hand function consists of 5 items (per hand), each scored from 1 (very good) to 5 (very bad). Domain scores are converted to a 0-100 scale, with 100 representing the best possible hand function, using the following formula: -(raw score-25)/20x100. The domain pain also consists of five items. After required recoding of item 1, domain scores are converted to a 0-100 scale, where 100 indicates no pain. If item 1 ("How often did you have pain in your hand(s)/wrist(s)?") is scored as 5 (no pain), the pain score is automatically set to 100. Otherwise, the domain score is calculated using the following formula:

    (raw score-5)/20×100.

  2. 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

    Time frame: At screening and baseline (i.e. 2 weeks after the screening). And 1, 4, 8 and 12 months after delivery of the hand orthosis.

    The D-CSD contains 10 items rated on a 5-point Likert scale ranging from 0 ('strongly disagree') to 4 ('strongly agree), with a total score ranging from 0-40. The D-CSD has sufficient content and structural validity, and good reliability.

  3. Orthosis satisfaction assessed with the Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST) at 4 months follow-up

    Time frame: 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.

    The D-QUEST assesses satisfaction with aspects related to the orthotic device and provided services. The device component of the D-QUEST consists of 8 questions about characteristics of the orthotic device, all scored on a 5-point scale (from 'not satisfied at all' to 'very satisfied'). Total scores for the device component range from 8 to 40, with higher scores indicating greater satisfaction. At follow-up assessments, the service component of the D-QUEST will also be assessed. This component consists of 4 additional questions. The scores from service component range from 4 to 20. The total scores of the complete D-QUEST range from 12 to 60.

  4. Change from baseline to 4 months follow-up in quality of life on the EuroQol 5-dimension 5-level (EQ-5D-5L)

    Time frame: At screening and baseline (i.e. 2 weeks after the screening). And 1, 4, 8 and 12 months after delivery of the hand orthosis.

    The EQ-5D-5L contains five questions about mobility, self-care, usual activities, pain/discomfort, and anxiety and depression scored on a 5-point scale indicating the degree of problems with each dimension and one question about experienced health scored on a 0-100 visual analogue scale.

  5. Change from baseline to 4 months follow-up in functional status assessed using the Patient Specific Complaints instrument (PSC)

    Time frame: 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.

    At the screening, three activities that the patient has difficulty with performing are identified and ranked according to importance. These activities are subsequently scored on a 0-10 scale, where 0 indicates no difficulty and 10 indicates that the activity is impossible to perform. Activities are scored for the situation with and without use of the hand orthosis.

  6. Experiences with the given interventions (patient)

    Time frame: At 1 month after delivery of the orthosis.

    At 1 month after delivery of the orthosis, a semi-structured interview will be conducted with the patient to discuss the experiences with the given orthosis. The interview data will be used in a qualitative analysis. Patients will be randomly selected and invited to participate in the interviews until data saturation is reached.

  7. Health care and societal costs assessed with a cost questionnaire

    Time frame: At 1, 4, 8 and 12 months follow-up.

    Patients fill out a cost questionnaire at the follow-up assessments to record health care costs related to the hand conditions after the intervention has started, as well as societal costs. These data will be used for the cost-effectiveness analysis.

  8. Production time of the orthosis (in minutes)

    Time frame: From the date of fitting of the hand orthosis until the date of delivery of the orthosis, assessed up to 1 month.

    The production time required for the manufacturing process of both types of orthoses will be recorded. These data will be used for the cost-effectiveness analysis.

  9. Production costs of the orthosis (in euro)

    Time frame: From the date of fitting of the hand orthosis until the date of delivery of the orthosis, assessed up to 1 month.

    The costs related to the manufacturing of the 3D-printed orthoses and conventional orthoses will be compared. These data will be used for the cost-effectiveness analysis.

  10. Experiences with development of the orthoses (orthotists from OIM Orthopedie)

    Time frame: From the date of fitting of the hand orthosis until the date of delivery of the orthosis, assessed up to 1 month.

    A semi-structured interview will be conducted with the orthotists from OIM Orthopedie to discuss the experiences with de developmental processes of both orthoses (3D-printed and conventional). These data will be used in a qualitative analysis.

Other outcomes

  1. Adverse events

    Time frame: Up to 12 months post intervention.

    The following adverse events reported by the participant or observed by the investigator or orthotist will be recorded; pressure sores, abrasions, pain due to the orthosis, and material damage of the orthosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Tanja Oud, PhD

CONTACT

[email protected]

31 20 5662615

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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