Recruiting

3D Printing

Sponsor:

ELewis

Code:

NCT07565636

Conditions

Ehlers-Danlos Syndrome Hypermobility Type (hEDS)

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

3D scanned and 3D printed wrist hand orthosis

Study Details

Brief 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.

Conditions

Ehlers-Danlos Syndrome Hypermobility Type (hEDS)

Study ID

NCT07565636

Start date

Aug 21, 2025

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • English-speaking
  • 21 or older
  • Ehlers-Danlos syndrome
  • wrist hypermobility

Exclusion Criteria:

  • Under 21
  • pregnant women
  • prisoners
  • non-English-speaking
  • skin sensitivity

Study Design

Enrollment

4 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

3D scanned and 3D printed wrist hand orthosis

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.

Primary outcome measure

  • Wrist Joint Stability [ Time Frame: From enrollment to the end of intervention at 8 weeks ]
  • 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 Activity Participation for individuals with EDS [ Time Frame: From enrollment to the end of intervention at 8 weeks ]
  • Satisfaction of person with EDS with 3D Scanned and 3D printed orthosis [ Time Frame: From Enrollment to the end of intervention at 8 weeks ]

Central Contacts and Locations

Central contacts

Erika Lewis, PT, EdD

978-934-4405Erika_Lewis@uml.edu

Yuko Oda, MFA, BA

978-934-3490Yuko_Oda@uml.edu

Locations

UMass Lowell, Expanded Media Fabrication Lab

Recruiting

Lowell, Massachusetts, United States, 01854

Contacts

Anna McCarthy, BFA

978-934-4294Anna_McCarthy@uml.edu

Principal Investigator:

Erika Lewis, PT, EdD

More Information

Sponsor

ELewis

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • 3D Printed orthosis
  • Ehlers-Danlos Syndrome (EDS)
  • orthosis
  • 3d scanned
  • subluxation
  • dislocation
  • subluxation wrist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ELewis on 2026-05-04.