RecruitingNot Applicable

3D Printed Orthosis for Wrist Instability for Ehlers-Danlos Syndrome Patient

United States4 participantsStarted 2025-08-21

Plain-language 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. 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * English-speaking * 21 or older * Ehlers-Danlos syndrome * wrist hypermobility Exclusion Criteria: * Under 21 * pregnant women * prisoners * non-English-speaking * skin sensitivity

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Wrist Joint Stability

Timeframe: From enrollment to the end of intervention at 8 weeks

Change in Pain Rating in upper extremity for individuals with EDS

Timeframe: From enrollment to the end of the intervention at 8 weeks

Change in Activity Participation for individuals with EDS

Timeframe: From enrollment to the end of intervention at 8 weeks

Satisfaction of person with EDS with 3D Scanned and 3D printed orthosis

Timeframe: From Enrollment to the end of intervention at 8 weeks

Trial details

NCT IDNCT07565636

SponsorELewis

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-08-31

Contact for this trial

Erika Lewis, PT, EdD

978-934-4405 Erika_Lewis@uml.edu

View on ClinicalTrials.gov More Ehlers-Danlos Syndrome Hypermobility Type (hEDS) trials

Plain-language summary

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Wrist Joint Stability

Timeframe: From enrollment to the end of intervention at 8 weeks

Change in Pain Rating in upper extremity for individuals with EDS

Timeframe: From enrollment to the end of the intervention at 8 weeks

Change in Activity Participation for individuals with EDS

Timeframe: From enrollment to the end of intervention at 8 weeks

Satisfaction of person with EDS with 3D Scanned and 3D printed orthosis

Timeframe: From Enrollment to the end of intervention at 8 weeks