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

Custom Orthotic Using 3D Printed and 3D Scanned Method

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.

Study Overview

• Status: Recruiting
• Conditions: Ehlers-Danlos Syndrome Hypermobility Type (hEDS)
• Intervention / Treatment: Device: 3D scanned and 3D printed wrist hand orthosis

Detailed Description

The purpose of this study is to examine the impact that a 3D-scanned and 3D-printed forearm wrist and hand orthosis has on function, pain and quality of life for people with Ehlers-Danlos Syndrome.

The goal of this research is to create a more supportive wrist hand orthosis for people with Ehlers-Danlos Syndrome (EDS) to prevent wrist dislocation using 3D scanning and 3D printing technologies with a biomedically safe material and address concerns for an underserved medical population. The investigators' goal is to create an orthosis that works better than the traditional ones by providing more support and decreasing pain for the participants with EDS. The investigators will create a custom 3D scanned and 3D printed wrist-hand orthotic for the participant and evaluate if there is a change on number of subluxation/dislocation due to Ehlers- Danlos syndrome as it relates to pain, activity participation and patient satisfaction. To assess this, the investigators will use patient-rated outcome measures, such as: the 0-100 Pain Scale, daily # of subluxation/dislocation occurrences, activity level via Health Assessment Questionnaire HAQ-D1, and the OPUS Satisfaction with Device and Services survey.

Aim 1: Develop a custom 3D-printed wrist-hand orthosis for participants with Ehlers-Danlos Syndrome (EDS) using 3D scanning and printing technologies.

The investigators will design and fabricate a custom orthosis tailored to each participant's unique anatomical needs using biomedically safe materials. The aim is to create an orthotic device that provides enhanced support to the wrist and hand, preventing subluxation and dislocation while minimizing pain compared to pre-fabricated orthoses.

Aim 2: Evaluate the effectiveness of the custom 3D-printed orthosis in changing the number of wrist subluxation/dislocation and changing the pain levels in participants with EDS.

The investigators will assess the effectiveness of the wrist-hand orthosis by measuring the frequency of subluxation/dislocation events and evaluating pain levels before and after wearing the device. The 0-100 Pain Scale will be used to quantify pain relief, and the occurrence of wrist subluxation/dislocation will be recorded to determine the device's impact on joint stability.

Aim 3: Assess the impact of the custom 3D-printed orthosis on activity participation and overall functional status in individuals with EDS.

The investigators will measure changes in activity levels and functional status using patient-reported outcome measures, including the Health Assessment Questionnaire HAQ-DI, and OPUS Satisfaction with Device and Services. These metrics will provide insight into the orthosis's ability to enhance participation in daily activities and improve overall quality of life for individuals with EDS.

Aim 4: Measure participant satisfaction with the custom 3D-printed orthosis. The investigators will use the OPUS Satisfaction with Device and Services survey to evaluate patient satisfaction with the orthosis. This will help determine whether the 3D-printed orthosis meets the unique needs and preferences of individuals with EDS in terms of comfort, functionality, and usability.

• Study Type: Observational
• Enrollment (Estimated): 4

Contacts and Locations

• Study Contact: Name: Erika Lewis, PT, EdD; Phone Number: 978-934-4405; Email: Erika_Lewis@uml.edu
• Study Contact Backup: Name: Yuko Oda, MFA, BA; Phone Number: 978-934-3490; Email: Yuko_Oda@uml.edu

Study Locations

• United States
  • Massachusetts
    • Lowell, Massachusetts, United States, 01854
      • Recruiting
      • UMass Lowell, Expanded Media Fabrication Lab
      • Contact: Anna McCarthy, BFA; Phone Number: 978-934-4294; Email: Anna_McCarthy@uml.edu
      • Principal Investigator: Erika Lewis, PT, EdD
      • Principal Investigator: Yuko Oda, MFA, BA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ELewis
• Collaborators: University of Massachusetts, Lowell
• Investigators: Principal Investigator: Erika S Lewis, PT, EdD, University of Massachusetts, Lowell

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 30, 2025
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: orthosis; dislocation; subluxation; 3D Printed orthosis; Ehlers-Danlos Syndrome (EDS); 3d scanned; subluxation wrist
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Joint Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Hematologic Diseases; Skin Diseases; Congenital Abnormalities; Hemostatic Disorders; Hemorrhagic Disorders; Skin Diseases, Genetic; Skin Abnormalities; Collagen Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Joint Dislocations; Ehlers-Danlos Syndrome; Ehlers-Danlos syndrome type 3
• Other Study ID Numbers: 23 (SIME)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual Participant Data Set - Pain rating, OPUS HQOL index, OPUS satisfaction with Device and Services survey (Devices only), # daily subluxations/dislocations Study Protocol Statistical Analysis Plan Informed Consent Form Data Monitoring Committee Charter - IRB Research integrity manager Clinical Study Report
• IPD Sharing Time Frame: June 2026 - June 2029
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No