Hand Injuries and DisordersNCT05320211
Three-dimensional Printed Hand Orthoses
A study testing 3D-printed hand orthosis in people with Hand Injuries and Disorders, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Injuries and Disorders
- What is being tested?
- 3D-printed hand orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Apr 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of rehabilitation medicine Amsterdam UMC, location AMC
Amsterdam, 1105AZ
About this study
Official title: 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.
- Conditions
- Hand Injuries and Disorders
- Being tested
- 3D-printed hand orthosis
- Keywords
- feasibility, hand, orthotic device, printing; three-dimensional, activities, daily living, satisfaction, production time, costs
- Medical subject headings
- Hand Injuries, Disease, Motor Activity, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed hand orthosisDevice
3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional orthoses (control condition at baseline)
| Study group | Role | What they receive |
|---|---|---|
| 3D-printed hand orthoses | Experimental | Not described Receives: Device: 3D-printed hand orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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
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).
Measured: 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.
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.
Measured: Baseline; 1 month post-intervention, 4 months post-intervention
Production time of the orthosis (in minutes).
For each step in manufacturing the orthosis until final delivery, time will be recorded (with a stopwatch).
Measured: From start of the intervention up to delivery of the orthosis
Production costs of the orthosis (in euro).
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.
Measured: From start of the intervention up to delivery of the orthosis
Change from baseline in personal goals at 4 month 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).
Measured: Baseline; 1 month post-intervention, 4 months post-intervention
Change from baseline in orthosis use at 4 month 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.
Measured: Baseline; 1 month post-intervention, 4 months post-intervention
Patient and therapist experiences with the 3D orthosis
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.
Measured: 1 month post-treatment
Number of visits for fabrication of the 3D orthosis
The total number of visits for fabricating the 3D orthosis will be obtained from the administration records of OIM
Measured: From start of the intervention up to delivery of the orthosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start12 Apr 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hand Injuries and DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- within-subjects design
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Merel Brehm, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Prof. dr. Frans Nollet, MD PhD, Study director, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320211
- Sponsor's protocol ID
- 10310012110002
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34793566Oud 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.
PubMed 33884150Oud 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.
PubMed 37605151Oud 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.
PubMed 37024252
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Printed Orthoses for Improving Daily Functioning in Chronic Hand Conditions
- ClinicalTrials.gov ID
- NCT05320211
- Acronym / sponsor ID
- 10310012110002
- Conditions
- Hand Injuries and Disorders
- Keywords
- feasibility, hand, orthotic device, printing; three-dimensional, activities, daily living, satisfaction, production time, costs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- within-subjects design
| Arm | Type | Receives |
|---|---|---|
| 3D-printed hand orthoses | Experimental | Device: 3D-printed hand orthosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-printed hand orthosis3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional orthoses (control condition at baseline) | Device | 3D-printed hand orthoses |
Primary outcome
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.
10 secondary outcomes
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
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
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
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
Production time of the orthosis (in minutes).
Time frame: 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
Change from baseline in personal goals at 4 month post-intervention.
Time frame: 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
Patient and therapist experiences with the 3D orthosis
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 34793566Oud 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.
- Background: PubMed 33884150Oud 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.
- Derived from this study: PubMed 37605151Oud 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.
- Derived from this study: PubMed 37024252Oud 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. dr. Frans Nollet, MD PhD study director
Amsterdam UMC, location AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-printed hand orthosis in people with Hand Injuries and Disorders, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05320211, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.