Three-dimensional Printed Hand Orthoses

March 30, 2023 updated by: Merel Brehm, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Three-dimensional Printed Orthoses for Improving Daily Functioning in Chronic Hand Conditions

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
        • Department of rehabilitation medicine Amsterdam UMC, location AMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 3D-printed hand orthoses
Device: 3D-printed hand orthosis
3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional orthoses (control condition at baseline)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 2 weeks pre-intervention; baseline; 1 month post-intervention; 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention
MHQ-DVL domain items are scored from 0 - 100, in which 100 is the best possible ability, while for pain a score of 0 indicates no pain. The total MHQ-DLV score is calculated as the mean of all 6 domains (after converting pain from a "best score of 0" scale to a "best score of 100" scale). Note. For this study, the reliability of the MHQ-DLV in persons with chronic hand conditions will be determined.
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
Time Frame: Baseline; 1 month post-intervention; 4 months post-intervention
The D-QUEST assesses satisfaction with aspects related to the device and provided services. For this study, only the device-part of the D-QUEST will be used, which comprises 8 questions about certain characteristics of the orthotic device, all scored on a 5-point scale (from 'not satisfied at all' to 'very satisfied'), with a total score ranging from 8-40 (with 40 being the best possible satisfaction score).
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.
Time Frame: Baseline; 1 month post-intervention, 4 months post-intervention
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.
Baseline; 1 month post-intervention, 4 months post-intervention
Production time of the orthosis (in minutes).
Time Frame: From start of the intervention up to delivery of the orthosis
For each step in manufacturing the orthosis until final delivery, time will be recorded (with a stopwatch).
From start of the intervention up to delivery of the orthosis
Production costs of the orthosis (in euro).
Time Frame: From start of the intervention up to delivery of the orthosis
Costs of the conventional orthoses will be retrospectively inventoried from the administration records of OIM. Costs related to the manufacturing of the 3D-printed orthoses will be prospectively assessed.
From start of the intervention up to delivery of the orthosis
Change from baseline in personal goals at 4 month post-intervention.
Time Frame: Baseline; 1 month post-intervention, 4 months post-intervention
An in-house usability questionnaire will be used to inventory information on personal goals of the orthosis, and whether this goal has been achieved (scored on a 10-point-scale, ranging from 1: not achieved at all to 10: very well achieved).
Baseline; 1 month post-intervention, 4 months post-intervention
Change from baseline in orthosis use at 4 month post-intervention.
Time Frame: Baseline; 1 month post-intervention, 4 months post-intervention
An in-house usability questionnaire will be used to inventory how often the orthosis is used, classified in 5 categories; ranging from never until 6-7 days a week.
Baseline; 1 month post-intervention, 4 months post-intervention
Patient and therapist experiences with the 3D orthosis
Time Frame: 1 month post-treatment
Experiences of patients and health care providers with respect to the time window of the 3D intervention and satisfaction with the treatment process will be assessed with an in-house questionnaire, with items scored on a 5-point Likert scale.
1 month post-treatment
Number of visits for fabrication of the 3D orthosis
Time Frame: From start of the intervention up to delivery of the orthosis
The total number of visits for fabricating the 3D orthosis will be obtained from the administration records of OIM
From start of the intervention up to delivery of the orthosis
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.
Time Frame: 2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention
The CSD contains 9 items rated on a 5-point Likert scale ranging from 0 ('strongly disagree') to 4 ('strongly agree), with a total score ranging from 0-36. Since the CSD is not yet available in Dutch, the investigators will translate it into the Dutch language and assess its content validity, structural validity, and reliability in Dutch orthotic users.
2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: up to 4 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 4 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Prof. dr. Frans Nollet, MD PhD, Amsterdam UMC, location AMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10310012110002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual participant data (IPD) and meta data will be made available to third parties via Figshare. Other anonymized IPD and documents will be made available on request including data analysis codes such as SPSS syntaxes or R scripts.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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