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3D Hand Orthosis Trial

5. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

100

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Holandsko
    • North Holland
      • Amsterdam, North Holland, Holandsko, 1105 AZ
        • Amsterdam UMC, location AMC
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 3D-printed hand orthosis (intervention)
Přístroj: Conventional hand orthosis (control)
3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional hand orthoses (control)
Aktivní komparátor: Conventional hand orthosis (control)
Přístroj: 3D-printed hand orthosis (intervention)
3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional orthoses (control)

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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)
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline to 4 months follow-up in overall hand function and pain on the MHQ-DLV (Michigan Hand Questionnaire-Dutch Language version)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Adverse events
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

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

Spolupracovníci

ZonMw: The Netherlands Organisation for Health Research and Development

Vyšetřovatelé

  • Vrchní vyšetřovatel: Merel-Anne Brehm, PhD, Amsterdam UMC, location AMC

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. května 2030

Dokončení studie (Odhadovaný)

1. září 2030

Termíny zápisu do studia

První předloženo

1. června 2026

První předloženo, které splnilo kritéria kontroly kvality

5. června 2026

První zveřejněno (Aktuální)

8. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 10310012410005
  • 2025.1123 (Jiný identifikátor: METC Amsterdam UMC)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

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

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ANALYTIC_CODE
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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