Custom 3D-printed wrist and hand orthosis for hypermobile Ehlers-Danlos patients
Custom Orthotic Using 3D Printed and 3D Scanned Method
This project will try a custom 3D-scanned and 3D-printed wrist/hand brace to see if it reduces pain, cuts down on dislocations and subluxations, and helps adults with hypermobile Ehlers-Danlos Syndrome do daily activities more easily.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Massachusetts, Lowell Academic / other |
| Locations | 1 site (Lowell, Massachusetts) |
| Trial ID | NCT07565636 on ClinicalTrials.gov |
What this trial studies
Participants will receive a custom wrist-hand orthosis created from a 3D scan and printed in a biomedically safe material, tailored to their anatomy. This observational protocol will track pain (0-100 scale), daily counts of subluxations/dislocations, activity level via the HAQ-D1, and device satisfaction via the OPUS survey. The team will compare these patient-reported outcomes to participants' prior experience with prefabricated orthoses. Recruitment is limited to adult English-speaking participants with wrist hypermobility and Ehlers-Danlos Syndrome at UMass Lowell.
Who should consider this trial
Good fit: Adults (21+) who have hypermobile Ehlers-Danlos Syndrome with wrist hypermobility, can read English, and can attend visits at the UMass Lowell fabrication lab are ideal candidates.
Not a fit: People who are under 21, pregnant, incarcerated, non-English-speaking, or who have skin sensitivity to the device materials are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, a custom 3D-printed orthosis could reduce wrist pain and instability, enabling people with hEDS to participate more in self-care and recreational activities with less fear.
How similar studies have performed: Custom 3D-printed orthoses have shown promise in small studies for other joint conditions, but using 3D scanning and printing specifically for wrist instability in hEDS is relatively novel and not yet proven in large trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * English-speaking * 21 or older * Ehlers-Danlos syndrome * wrist hypermobility Exclusion Criteria: * Under 21 * pregnant women * prisoners * non-English-speaking * skin sensitivity
Where this trial is running
Lowell, Massachusetts
- UMass Lowell, Expanded Media Fabrication Lab — Lowell, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Erika S Lewis, PT, EdD — University of Massachusetts, Lowell
- Study coordinator: Erika Lewis, PT, EdD
- Email: Erika_Lewis@uml.edu
- Phone: 978-934-4405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.