Hand Injuries and DisordersNCT07633821
3D Hand Orthosis Trial
A study testing 3D-printed hand orthosis (intervention) in people with Hand Injuries and Disorders and Neurological Conditions, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Injuries and Disorders, Neurological Conditions, Neuromuscular Diseases (NMD)
- What is being tested?
- 3D-printed hand orthosis (intervention)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Sep 2026to Sep 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Indicated for an orthosis for a non-functional hand;
- Insufficient mastery of the Dutch language.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ
Dr. Merel-Anne Brehm, PhD, +31 (0)20 5663345, m.a.brehm@amsterdamumc.nl
About this study
Official title: 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:
- 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.
- To assess whether treatment with 3D-printed hand orthoses results in greater patient satisfaction compared to treatment with conventional hand orthoses.
- To assess the cost-effectiveness of treatment with 3D-printed hand orthoses compared to treatment with conventional hand orthoses.
- Conditions
- Hand Injuries and Disorders, Neurological Conditions, Neuromuscular Diseases (NMD), Musculoskeletal Conditions (e.g., Tendinitis, Capsulitis)
- Being tested
- 3D-printed hand orthosis (intervention), Conventional hand orthosis (control)
- Keywords
- Orthotic Devices, Cost-Effectiveness Analysis, Hand, Printing, Three-Dimensional, Activities of Daily Living, Rehabilitation, Quality of Life, Non-Inferiority Trial, Patient Satisfaction
- Medical subject headings
- Hand Injuries, Disease, Neuromuscular Diseases, Tendinopathy, Bursitis, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 3D-printed hand orthosis (intervention) | Experimental | Not described Receives: Device: Conventional hand orthosis (control) |
| Conventional hand orthosis (control) | Active comparator | Not described Receives: Device: 3D-printed hand orthosis (intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: 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 outcomes (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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: At 1 month after delivery of the orthosis.
Health care and societal costs assessed with a cost questionnaire
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.
Measured: At 1, 4, 8 and 12 months follow-up.
Production time of the orthosis (in minutes)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: From the date of fitting of the hand orthosis until the date of delivery of the orthosis, assessed up to 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start14 Sep 2026
- Primary completionMay 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hand Injuries and DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Merel Brehm, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Merel-Anne Brehm, PhD, Principal investigator, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633821
- Sponsor's protocol ID
- 10310012410005
- Other IDs
- 2025.1123
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40472141Oud 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.
PubMed 37605151Oud 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.
PubMed 33884150Oud 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.
PubMed 38742877Oud 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.
PubMed 37024252