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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional orthoses (control)
3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional hand orthoses (control)
Amsterdam UMC, location AMC
Amsterdam, North Holland, Netherlands
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the date of fitting of the hand orthosis until the date of delivery of the orthosis, assessed up to 1 month.
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