Custom Orthotic Using 3D Printed and 3D Scanned Method
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.
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.
Inclusion Criteria:
Exclusion Criteria:
Erika_Lewis@uml.edu978-934-4405
Yuko_Oda@uml.edu978-934-3490