Clinical trial NCT05320211: Three-dimensional Printed Hand Orthoses
Official title: Three-dimensional Printed Orthoses for Improving Daily Functioning in Chronic Hand Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Injuries and Disorders
Keywords: feasibility
hand
orthotic device
printing; three-dimensional
activities, daily living
satisfaction
production time
costs
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-04-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: within-subjects design
Primary purpose: TREATMENT

Brief summary: In persons with chronic hand conditions, orthoses are often prescribed to improve daily-life functioning. In most cases, orthoses are custom manufactured based on a plaster hand model, which is a time-consuming and labor-intensive process. It has been demonstrated that the production time to custom manufacture hand orthoses can be greatly reduced by using three-dimensional (3D) scanning and printing, offering a promising cost-effective alternative to conventional costum manufactured hand orthoses. However, before setting up a cost-effectiveness study in persons with chronic hand conditions, insight into the effectiveness of 3D-printed orthoses on performance of activities of daily living (ADL) is needed, as well as insight into potential cost reductions. To date, this information is largely unknown. The aims of this feasibility study are 1) to collect data on the preliminary effectiveness of 3D-printed orthoses on performance of ADL, satisfaction with the orthosis and quality of life compared to conventional orthoses in persons with chronic hand conditions, and 2) to compare the production time and costs of 3D-printed orthoses with conventional orthoses.


Eligibility criteria: Inclusion Criteria:

1. Having a chronic hand-wrist condition due to an injury, or a musculoskeletal disorder, neuromuscular disorder, or neurological disorder;
2. Minimum age of 18 years;
3. Currently wearing a conventional custom manufactured hand orthosis (including a wrist-orthosis, wrist/thumb orthosis or thumb orthosis) for permanent use;
4. Indicated for a new hand orthosis.

Exclusion Criteria:

1. Already wearing a 3D-printed orthosis
2. Wearing a silver wrist-orthosis, wrist/thumb orthosis or thumb orthosis
3. Wearing an orthosis prescribed for a dysfunctional hand;
4. Wearing a broken orthosis;
5. Wearing the orthosis only at night;
6. Worsening of disease;
7. Insufficient mastery of the Dutch language.

Primary outcomes:
measure: Change from baseline in performance of ADL on the custom short form of the Dutch-Flemish Patient-Reported Outcomes Measurement Information System - Upper extremity (DF-PROMIS-UE) at 4 months post-intervention.
timeFrame: 2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention
Secondary outcomes:
measure: Change from baseline in performance of ADL, overall hand function, pain, work, performance, aesthetics, and satisfaction on the Michigan Hand Questionnaire-Dutch Language version (MHQ-DLV) at 4 months post-intervention.
timeFrame: 2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention
measure: Change from baseline in satisfaction assessed with the Dutch version of the Client Satisfaction with Device (CSD) module of the Orthotics and Prosthetics User's Survey (OPUS) at 4 months post-intervention.
timeFrame: 2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention
measure: Change from baseline in satisfaction assessed with the Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST) at 4 months post-intervention
timeFrame: Baseline; 1 month post-intervention; 4 months post-intervention
measure: Change in quality of life on the 5-dimension 5-level EuroQol (EQ-5D-5L) at 4 months post-intervention.
timeFrame: Baseline; 1 month post-intervention, 4 months post-intervention
measure: Production time of the orthosis (in minutes).
timeFrame: From start of the intervention up to delivery of the orthosis
measure: Production costs of the orthosis (in euro).
timeFrame: From start of the intervention up to delivery of the orthosis
measure: Change from baseline in personal goals at 4 month post-intervention.
timeFrame: Baseline; 1 month post-intervention, 4 months post-intervention
measure: Change from baseline in orthosis use at 4 month post-intervention.
timeFrame: Baseline; 1 month post-intervention, 4 months post-intervention
measure: Patient and therapist experiences with the 3D orthosis
timeFrame: 1 month post-treatment
measure: Number of visits for fabrication of the 3D orthosis
timeFrame: From start of the intervention up to delivery of the orthosis
Other outcomes:
measure: Adverse events
timeFrame: up to 4 months post intervention
Locations:
city: Amsterdam
country: Netherlands
facility: Department of rehabilitation medicine Amsterdam UMC, location AMC
Study officials:
affiliation: Amsterdam UMC, location AMC
name: Prof. dr. Frans Nollet, MD PhD
role: STUDY_DIRECTOR
References:
citation: Oud TAM, Lazzari E, Gijsbers HJH, Gobbo M, Nollet F, Brehm MA. Effectiveness of 3D-printed orthoses for traumatic and chronic hand conditions: A scoping review. PLoS One. 2021 Nov 18;16(11):e0260271. doi: 10.1371/journal.pone.0260271. eCollection 2021.
citation: Oud 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.