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 — DEVICE
    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 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

Locations (1)

FacilityCityStateZIPSite coordinators
UMass Lowell, Expanded Media Fabrication LabLowellMassachusetts01854
Anna McCarthy, BFA
978-934-4294
Erika Lewis, PT, EdD (PRINCIPAL_INVESTIGATOR)
Yuko Oda, MFA, BA (PRINCIPAL_INVESTIGATOR)

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