3D Printed Orthosis for Wrist Instability for Ehlers-Danlos Syndrome Patient
Part of paid clinical trials in Lowell, Massachusetts.
- Sponsor
- ELewis
- Study ID
- NCT07565636
- Status
- Recruiting
Conditions
- Ehlers-Danlos Syndrome Hypermobility Type (hEDS)
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 3D scanned and 3D printed wrist hand orthosis — DEVICEFabricate 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 Details
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.
Key Dates
- Start date
- Aug 21, 2025
- Status verified
- Apr 2026
- Primary completion
- Aug 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 4 participants (estimated)
Arms
- Arm: 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
Primary Outcome Measure
Wrist Joint Stability [ Time Frame: From enrollment to the end of intervention at 8 weeks ]
Central Contacts
- Erika Lewis, PT, EdD978-934-4405
- Yuko Oda, MFA, BA978-934-3490
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UMass Lowell, Expanded Media Fabrication Lab | Lowell | Massachusetts | 01854 | Erika Lewis, PT, EdD (PRINCIPAL_INVESTIGATOR) Yuko Oda, MFA, BA (PRINCIPAL_INVESTIGATOR) |