3D Hand Orthosis Trial

June 5, 2026 updated by: Merel Brehm, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Amsterdam UMC, location AMC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D-printed hand orthosis (intervention)
Device: Conventional hand orthosis (control)
3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional hand orthoses (control)
Active Comparator: Conventional hand orthosis (control)
Device: 3D-printed hand orthosis (intervention)
3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional orthoses (control)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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)
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.
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)
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.
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)
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.
At 1 month after delivery of the orthosis.
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.
At 1, 4, 8 and 12 months follow-up.
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.
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)
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.
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)
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.
From the date of fitting of the hand orthosis until the date of delivery of the orthosis, assessed up to 1 month.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months post intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Merel-Anne Brehm, PhD, Amsterdam UMC, location AMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

June 1, 2026

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10310012410005
  • 2025.1123 (Other Identifier: METC Amsterdam UMC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual participant data (IPD) and meta data will be made available to third parties via SURF Data Archive. Other anonymized IPD and documents will be made available on request including data analysis codes such as SPSS syntaxes or R scripts.

IPD Sharing Time Frame

IPD and supporting information will be available medio 2030, after the study is finished. Data will be available for 10 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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