Ehlers-Danlos Syndrome Hypermobility Type (hEDS)NCT07565636
3D Printed Orthosis for Wrist Instability for Ehlers-Danlos Syndrome Patient
An observational study of Ehlers-Danlos Syndrome Hypermobility Type (hEDS), run by ELewis at 1 site in United States.
Trial summary
This study will determine if using 3D scanning and 3D printing technology to create an orthosis to improve the quality of life for people with Ehlers Danlos Syndrome (EDS) compared to existing prefabricated orthoses. Orthoses are often used by people with EDS to stabilize and support joints with hypermobile tissues. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ehlers-Danlos Syndrome Hypermobility Type (hEDS)
- What is being tested?
- 3D scanned and 3D printed wrist hand orthosis
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2025to 6 Aug 2026
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with hypermobile Ehlers-Danlos Syndrome with history of wrist pain and subluxations
Who may be able to join
- English-speaking
- 21 or older
- Ehlers-Danlos syndrome
- wrist hypermobility
Who cannot join
- Under 21
- pregnant women
- prisoners
- non-English-speaking
- skin sensitivity
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Lowell, Expanded Media Fabrication Lab
Lowell, Massachusetts, 01854
About this study
Official title: Custom Orthotic Using 3D Printed and 3D Scanned Method
This study will determine if using 3D scanning and 3D printing technology to create an orthosis to improve the quality of life for people with Ehlers Danlos Syndrome (EDS) compared to existing prefabricated orthoses. Orthoses are often used by people with EDS to stabilize and support joints with hypermobile tissues. Improving the quality of life will mean that people can participate in daily self-care and/or recreational activities that they enjoy, such as gardening and cooking. The investigators also seek to find if this orthosis will decrease pain and reduce the number of dislocations and subluxations. All these changes could lead to better mental health, decreasing the fear and anxiety related to dislocations and pain.
Read the detailed description
The purpose of this study is to examine the impact that a 3D-scanned and 3D-printed forearm wrist and hand orthosis has on function, pain and quality of life for people with Ehlers-Danlos Syndrome.
The goal of this research is to create a more supportive wrist hand orthosis for people with Ehlers-Danlos Syndrome (EDS) to prevent wrist dislocation using 3D scanning and 3D printing technologies with a biomedically safe material and address concerns for an underserved medical population. The investigators' goal is to create an orthosis that works better than the traditional ones by providing more support and decreasing pain for the participants with EDS. The investigators will create a custom 3D scanned and 3D printed wrist-hand orthotic for the participant and evaluate if there is a change on number of subluxation/dislocation due to Ehlers- Danlos syndrome as it relates to pain, activity participation and patient satisfaction. To assess this, the investigators will use patient-rated outcome measures, such as: the 0-100 Pain Scale, daily # of subluxation/dislocation occurrences, activity level via Health Assessment Questionnaire HAQ-D1, and the OPUS Satisfaction with Device and Services survey.
Aim 1: Develop a custom 3D-printed wrist-hand orthosis for participants with Ehlers-Danlos Syndrome (EDS) using 3D scanning and printing technologies.
The investigators will design and fabricate a custom orthosis tailored to each participant's unique anatomical needs using biomedically safe materials. The aim is to create an orthotic device that provides enhanced support to the wrist and hand, preventing subluxation and dislocation while minimizing pain compared to pre-fabricated orthoses.
Aim 2: Evaluate the effectiveness of the custom 3D-printed orthosis in changing the number of wrist subluxation/dislocation and changing the pain levels in participants with EDS.
The investigators will assess the effectiveness of the wrist-hand orthosis by measuring the frequency of subluxation/dislocation events and evaluating pain levels before and after wearing the device. The 0-100 Pain Scale will be used to quantify pain relief, and the occurrence of wrist subluxation/dislocation will be recorded to determine the device's impact on joint stability.
Aim 3: Assess the impact of the custom 3D-printed orthosis on activity participation and overall functional status in individuals with EDS.
The investigators will measure changes in activity levels and functional status using patient-reported outcome measures, including the Health Assessment Questionnaire HAQ-DI, and OPUS Satisfaction with Device and Services. These metrics will provide insight into the orthosis's ability to enhance participation in daily activities and improve overall quality of life for individuals with EDS.
Aim 4: Measure participant satisfaction with the custom 3D-printed orthosis. The investigators will use the OPUS Satisfaction with Device and Services survey to evaluate patient satisfaction with the orthosis. This will help determine whether the 3D-printed orthosis meets the unique needs and preferences of individuals with EDS in terms of comfort, functionality, and usability.
- Being tested
- 3D scanned and 3D printed wrist hand orthosis
- Keywords
- 3D Printed orthosis, Ehlers-Danlos Syndrome (EDS), orthosis, 3d scanned, subluxation, dislocation, subluxation wrist
- Medical subject headings
- Ehlers-Danlos syndrome type 3, Ehlers-Danlos Syndrome, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D scanned and 3D printed wrist hand orthosisDevice
Fabricate a Custom 3D scanned and 3D printed wrist-hand orthosis for a participant with EDS to measure the change in pain, number of daily wrist subluxation and change in participation in activities such as gardening and cooking. The investigators will use participant feedback to customize the fit and design of the orthosis for maximum comfort and effectiveness. The investigators are using HD (high definition) 3D scanning and 3D printing technology for a precise fit to prevent subluxation.
| Study group | Role | What they receive |
|---|---|---|
| Ehlers-Danlos Syndrome (EDS) | Individuals with EDS with symptoms of wrist subluxation or wrist dislocation causing limitation in participation in self-care and activities and social activities Receives: Device: 3D scanned and 3D printed wrist hand orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrist Joint Stability
Change the frequency of daily wrist subluxations and dislocations over 8 weeks (0-100, lower number is better)
Measured: From enrollment to the end of intervention at 8 weeks
Change in Pain Rating in upper extremity for individuals with EDS
Change in pain as measured by the pain rating on the Health Assessment Questionnaire (HAQ-DI) (0-100 where 0=no pain and 100 = severe pain. Lower number is better)
Measured: From enrollment to the end of the intervention at 8 weeks
Change in Activity Participation for individuals with EDS
Change in participation in daily activities, as indicated by improvements in the Health Assessment Questionnaire (HAQ-DI) (The 8 scores of the 8 sections are summed and divided by 8. The result is the DI or FDI, the disability index or functional disability index. Each question can be rated 0-3 with 0 representing better functional ability.)
Measured: From enrollment to the end of intervention at 8 weeks
Satisfaction of person with EDS with 3D Scanned and 3D printed orthosis
Change in satisfaction levels as measured by the OPUS Satisfaction with Device and Services survey Satisfaction With Device Score is the sum of the scores for items 1-11 (11 - 55). We will not use the "Satisfaction With Services Score is the sum of the scores for items 12-21 (10 - 50)". The higher the score the better the outcome
Measured: From Enrollment to the end of intervention at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start21 Aug 2025
- Primary completion6 Aug 2026
- Study completion6 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ehlers-Danlos Syndrome Hypermobility Type (hEDS)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- ELewis
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Lowell
- Responsible party
- Sponsor-investigator, ELewis, University of Massachusetts, Lowell
- Investigators
- Erika S Lewis, PT, EdD, Principal investigator, University of Massachusetts, Lowell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565636
- Sponsor's protocol ID
- 23
- Status last verified
- Apr 2026
- First submitted
- 30 May 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual Participant Data Set - Pain rating, OPUS HQOL index, OPUS satisfaction with Device and Services survey (Devices only), # daily subluxations/dislocations Study Protocol Statistical Analysis Plan Informed Consent Form Data Monitoring Committee Charter - IRB Research integrity manager Clinical Study Report
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Custom Orthotic Using 3D Printed and 3D Scanned Method
- ClinicalTrials.gov ID
- NCT07565636
- Acronym / sponsor ID
- 23
- Keywords
- 3D Printed orthosis, Ehlers-Danlos Syndrome (EDS), orthosis, 3d scanned, subluxation, dislocation, subluxation wrist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- ELewisUniversity, hospital or other
- Collaborators
- University of Massachusetts, Lowell
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 6 Aug 2026 (actual)
- First posted
- 4 May 2026 (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.
This study will determine if using 3D scanning and 3D printing technology to create an orthosis to improve the quality of life for people with Ehlers Danlos Syndrome (EDS) compared to existing prefabricated orthoses. Orthoses are often used by people with EDS to stabilize and support joints with hypermobile tissues. Improving the quality of life will mean that people can participate in daily self-care and/or recreational activities that they enjoy, such as gardening and cooking. The investigators also seek to find if this orthosis will decrease pain and reduce the number of dislocations and subluxations. All these changes could lead to better mental health, decreasing the fear and anxiety related to dislocations and pain.
Detailed description
The purpose of this study is to examine the impact that a 3D-scanned and 3D-printed forearm wrist and hand orthosis has on function, pain and quality of life for people with Ehlers-Danlos Syndrome.
The goal of this research is to create a more supportive wrist hand orthosis for people with Ehlers-Danlos Syndrome (EDS) to prevent wrist dislocation using 3D scanning and 3D printing technologies with a biomedically safe material and address concerns for an underserved medical population. The investigators' goal is to create an orthosis that works better than the traditional ones by providing more support and decreasing pain for the participants with EDS. The investigators will create a custom 3D scanned and 3D printed wrist-hand orthotic for the participant and evaluate if there is a change on number of subluxation/dislocation due to Ehlers- Danlos syndrome as it relates to pain, activity participation and patient satisfaction. To assess this, the investigators will use patient-rated outcome measures, such as: the 0-100 Pain Scale, daily # of subluxation/dislocation occurrences, activity level via Health Assessment Questionnaire HAQ-D1, and the OPUS Satisfaction with Device and Services survey.
Aim 1: Develop a custom 3D-printed wrist-hand orthosis for participants with Ehlers-Danlos Syndrome (EDS) using 3D scanning and printing technologies.
The investigators will design and fabricate a custom orthosis tailored to each participant's unique anatomical needs using biomedically safe materials. The aim is to create an orthotic device that provides enhanced support to the wrist and hand, preventing subluxation and dislocation while minimizing pain compared to pre-fabricated orthoses.
Aim 2: Evaluate the effectiveness of the custom 3D-printed orthosis in changing the number of wrist subluxation/dislocation and changing the pain levels in participants with EDS.
The investigators will assess the effectiveness of the wrist-hand orthosis by measuring the frequency of subluxation/dislocation events and evaluating pain levels before and after wearing the device. The 0-100 Pain Scale will be used to quantify pain relief, and the occurrence of wrist subluxation/dislocation will be recorded to determine the device's impact on joint stability.
Aim 3: Assess the impact of the custom 3D-printed orthosis on activity participation and overall functional status in individuals with EDS.
The investigators will measure changes in activity levels and functional status using patient-reported outcome measures, including the Health Assessment Questionnaire HAQ-DI, and OPUS Satisfaction with Device and Services. These metrics will provide insight into the orthosis's ability to enhance participation in daily activities and improve overall quality of life for individuals with EDS.
Aim 4: Measure participant satisfaction with the custom 3D-printed orthosis. The investigators will use the OPUS Satisfaction with Device and Services survey to evaluate patient satisfaction with the orthosis. This will help determine whether the 3D-printed orthosis meets the unique needs and preferences of individuals with EDS in terms of comfort, functionality, and usability.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ehlers-Danlos Syndrome (EDS) | – | Device: 3D scanned and 3D printed wrist hand orthosisIndividuals with EDS with symptoms of wrist subluxation or wrist dislocation causing limitation in participation in self-care and activities and social activities |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with hypermobile Ehlers-Danlos Syndrome with history of wrist pain and subluxations
Key inclusion criteria (4 listed)
- English-speaking
- 21 or older
- Ehlers-Danlos syndrome
- wrist hypermobility
Key exclusion criteria (5 listed)
- Under 21
- pregnant women
- prisoners
- non-English-speaking
- skin sensitivity
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 scanned and 3D printed wrist hand orthosisFabricate a Custom 3D scanned and 3D printed wrist-hand orthosis for a participant with EDS to measure the change in pain, number of daily wrist subluxation and change in participation in activities such as gardening and cooking. The investigators will use participant feedback to customize the fit and design of the orthosis for maximum comfort and effectiveness. The investigators are using HD (high definition) 3D scanning and 3D printing technology for a precise fit to prevent subluxation. | Device | Ehlers-Danlos Syndrome (EDS) |
Primary outcome
Wrist Joint Stability
Time frame: From enrollment to the end of intervention at 8 weeks
Change the frequency of daily wrist subluxations and dislocations over 8 weeks (0-100, lower number is better)
Change in Pain Rating in upper extremity for individuals with EDS
Time frame: From enrollment to the end of the intervention at 8 weeks
Change in pain as measured by the pain rating on the Health Assessment Questionnaire (HAQ-DI) (0-100 where 0=no pain and 100 = severe pain. Lower number is better)
Change in Activity Participation for individuals with EDS
Time frame: From enrollment to the end of intervention at 8 weeks
Change in participation in daily activities, as indicated by improvements in the Health Assessment Questionnaire (HAQ-DI) (The 8 scores of the 8 sections are summed and divided by 8. The result is the DI or FDI, the disability index or functional disability index. Each question can be rated 0-3 with 0 representing better functional ability.)
Satisfaction of person with EDS with 3D Scanned and 3D printed orthosis
Time frame: From Enrollment to the end of intervention at 8 weeks
Change in satisfaction levels as measured by the OPUS Satisfaction with Device and Services survey Satisfaction With Device Score is the sum of the scores for items 1-11 (11 - 55). We will not use the "Satisfaction With Services Score is the sum of the scores for items 12-21 (10 - 50)". The higher the score the better the outcome
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 14 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual Participant Data Set - Pain rating, OPUS HQOL index, OPUS satisfaction with Device and Services survey (Devices only), # daily subluxations/dislocations Study Protocol Statistical Analysis Plan Informed Consent Form Data Monitoring Committee Charter - IRB Research integrity manager Clinical Study Report
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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.
Erika S Lewis, PT, EdD principal investigator
University of Massachusetts, Lowell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ehlers-Danlos Syndrome Hypermobility Type (hEDS), run by ELewis at 1 site in United States.
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 5 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 14 Sep 2026. 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 United States. 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?
Wrist Joint Stability (time frame: From enrollment to the end of intervention at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.