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

NCT07565636 | Recruiting FDA Device

• 1 other identifier: 23
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Wrist Joint Stability

  Change the frequency of daily wrist subluxations and dislocations over 8 weeks (0-100, lower number is better)

  From enrollment to the end of intervention at 8 weeks

• Change in Pain Rating in upper extremity for individuals with EDS

  Change in pain as measured by the pain rating on the Health Assessment Questionnaire (HAQ-DI) (0-100 where 0=no pain and 100 = severe pain. Lower number is better)

  From enrollment to the end of the intervention at 8 weeks

• Change in Activity Participation for individuals with EDS

  Change in participation in daily activities, as indicated by improvements in the Health Assessment Questionnaire (HAQ-DI) (The 8 scores of the 8 sections are summed and divided by 8. The result is the DI or FDI, the disability index or functional disability index. Each question can be rated 0-3 with 0 representing better functional ability.)

  From enrollment to the end of intervention at 8 weeks

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

  Change in satisfaction levels as measured by the OPUS Satisfaction with Device and Services survey Satisfaction With Device Score is the sum of the scores for items 1-11 (11 - 55). We will not use the "Satisfaction With Services Score is the sum of the scores for items 12-21 (10 - 50)". The higher the score the better the outcome

  From Enrollment to the end of intervention at 8 weeks

Study Arms (1)

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

Device: 3D scanned and 3D printed wrist hand orthosis

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.

Ehlers-Danlos Syndrome (EDS)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with hypermobile Ehlers-Danlos Syndrome with history of wrist pain and subluxations

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• ELewis: lead
• University of Massachusetts, Lowell: collaborator

Study Sites (1)

UMass Lowell, Expanded Media Fabrication Lab

Lowell, Massachusetts, 01854, United States

RECRUITING

MeSH Terms

Conditions

Ehlers-Danlos syndrome type 3; Ehlers-Danlos Syndrome; Joint Dislocations

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Officials

• Erika S Lewis, PT, EdD

  University of Massachusetts, Lowell

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erika Lewis, PT, EdD

CONTACT

978-934-4405; Erika_Lewis@uml.edu

Yuko Oda, MFA, BA

CONTACT

978-934-3490; Yuko_Oda@uml.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Physical Therapy & Kinesiology

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: May 4, 2026
• Study Start: August 21, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: June 2026 - June 2029
• Access Criteria: Other researchers in the field researching EDS or 3D scanning and 3D printed orthoses. We will share Pain rating, OPUS HQOL index, OPUS satisfaction with Device and Services survey. The researchers can contact us via email to access the information.

Locations

US (1)