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

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.

Wrist Joint Stability

Time frame: From enrollment to the end of intervention at 8 weeks

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

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 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)

Change in Activity Participation for individuals with EDS

Time frame: From enrollment to the end of intervention at 8 weeks

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.)

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

Time frame: From Enrollment to the end of intervention at 8 weeks

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

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.