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.
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.
Indicated for an orthosis for a non-functional hand;
Insufficient mastery of the Dutch language.
Parallel
3D-printed hand orthosis (intervention)
Device3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional orthoses (control)
Conventional hand orthosis (control)
Device3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional hand orthoses (control)
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.
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.
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.
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.
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.
Adverse events
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.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
