Three-dimensional Printed Hand Orthoses

NCT05320211 | Completed

• 1 other identifier: 10310012110002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Injuries and Disorders

Keywords

feasibility; hand; orthotic device; printing; three-dimensional; activities, daily living; satisfaction; production time; costs

Outcome Measures

Primary Outcomes (1)

• 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.

  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, which is a standardized score, with 50 representing the average score of the US general population and 10 being its standard deviation (SD). Note. For this study, the reliability of the DF-PROMIS-UE in persons with chronic hand conditions will be determined.

  2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention

Secondary Outcomes (10)

• 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.

  2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention

• 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.

  2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention

• 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

  Baseline; 1 month post-intervention; 4 months post-intervention

• Change in quality of life on the 5-dimension 5-level EuroQol (EQ-5D-5L) at 4 months post-intervention.

  Baseline; 1 month post-intervention, 4 months post-intervention

• Production time of the orthosis (in minutes).

  From start of the intervention up to delivery of the orthosis

Other Outcomes (1)

• Adverse events

  up to 4 months post intervention

Study Arms (1)

3D-printed hand orthoses

EXPERIMENTAL

Device: 3D-printed hand orthosis

Interventions

3D-printed hand orthosis DEVICE

3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional orthoses (control condition at baseline)

3D-printed hand orthoses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Department of rehabilitation medicine Amsterdam UMC, location AMC

Amsterdam, 1105AZ, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 34793566 BACKGROUND

• 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.

  PMID: 33884150 BACKGROUND

• Oud 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.

  PMID: 37605151 DERIVED

• Oud 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.

  PMID: 37024252 DERIVED

MeSH Terms

Conditions

Hand Injuries; Disease; Motor Activity; Personal Satisfaction

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Prof. dr. Frans Nollet, MD PhD

  Amsterdam UMC, location AMC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: within-subjects design

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 11, 2022
• Study Start: April 12, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)