Novel Splinting Technique Using 3D Models

Status unconfirmed · Not applicable

Conditions studied: Arthritis, Osteoarthritis Hand, Scleroderma, Systemic, Scleroderma, Diffuse, Rheumatoid Arthritis

In brief

The purpose of the study is to determine the feasibility of a non-contact custom splint fabrication method for patients with chronic diseases suffering from hypersensitive skin or compromised skin integrity. Custom splinting by occupational therapists involves molding low-temperature thermoplastic material directly on patients' skin; however, skin sensitivity is a contraindication for splint fabrication. The study aims to recruit 10 male or female patients with either a diagnosis of scleroderma (SSc) or arthritis. A scan of the patient's hand and a 3D printer will be used to create a precise model of a patient's hand on which a custom splint will be fabricated. By taking this approach, traditional splinting is substituted by avoiding direct contact with the material on the surface of the patient's upper extremity. This technique creates therapeutic opportunities for underserved patients by expanding splinting options for patients with scleroderma and arthritis, and addressing the challenges associated with managing chronic diseases.

Key facts

Study ID

NCT05351060

Run by

Giovanna Fichera

People needed

10

Starts

2022-05-16

Expected to finish

2022-08-19

Last updated by the study team

2022-04-28

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of either scleroderma, osteoarthritis, or rheumatoid arthritis
• Must have the potential to benefit from wearing a resting hand splint as determined by a certified hand therapist
• Over 18 years of age
• Fluent in English

You may not qualify if…

• Patients exhibiting any open wounds on their hands or forearms
• Exhibiting impaired decision making and ability to understand splint care and wear instructions as determined by the ability to answer the questions the student researcher asks after the participant has reviewed the splint education handout
• Under 18 years of age
• Unable to secure reliable transport for the duration of the study

Where it is running

• Russell Sage College — Troy, New York, United States

Full record on ClinicalTrials.gov

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