Novel Splinting Technique Using 3D Models

NCT ID: NCT05351060

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2022-08-19

Brief Summary

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.

Detailed Description

Arthritis is an inflammatory disease that occurs in the joints of the body. Scleroderma is a disease of the autoimmune system in which the body produces excess collagen in the skin and organs. Depending upon a patient's needs, occupational therapists (OTs) make custom hand splints to support individual goals and promote independence. Conventional splinting methods involve molding low-temperature thermoplastic material directly on a patients' skin; however, many chronic diseases including arthritis and scleroderma carry a predisposition for skin sensitivity or compromised skin integrity, leaving these populations with no alternative. The study will recruit 10 male or female patients with either a diagnosis of arthritis or scleroderma for a 14-week study. Researchers will use a scanner and 3D printer to create a model of a patient's hand prior to splinting, which will allow therapists to custom-fit the 105-degree splinting material on the model. Traditional splinting is substituted by avoiding fabricating the splint directly on the patient's hand and providing the opportunity for patients with hypersensitive skin to benefit from a custom-made splint. Implementing this technique creates opportunities by expanding splinting options for patients with chronic diseases. The goals of this study are to evaluate effectiveness, support positive engagement in daily activities, improve patient outcomes, and promote best practice. The research will also establish a foundation for future studies with custom splinting using 3D printed material.

Conditions

Arthritis; Osteoarthritis Hand; Scleroderma, Systemic; Scleroderma, Diffuse; Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

3D model splinting intervention group

The researcher will scan the participant's forearm, wrist, and hand with an iPhone camera through the Comb O\&P Scan App. Scans will be completed individually to maintain privacy. The entire Comb O\&P platform is HIPAA compliant. The data is de-identified encrypted when it moves from the iPhone app to the computer through the cloud. Precision Valve Automation (PVA) will use the de-identified scans to print the 3D models which are a precise replica of the participant's hand. Once the researcher obtains the 3D models, resting hand splints will be fabricated on the 3D models to provide custom-made hand splint(s) to each participant. The participants will receive the splint(s) to wear during the hours of sleep for six weeks.

Group Type: EXPERIMENTAL

Custom Fabricated Splint

Intervention Type: OTHER

Participants will wear a customized splint on their affected hand(s)during the hours of sleep for the duration of the study.

Interventions

Custom Fabricated Splint

Participants will wear a customized splint on their affected hand(s)during the hours of sleep for the duration of the study.

Intervention Type: OTHER

Other Intervention Names

Orthotic

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Precision Valve Automation

UNKNOWN

Sponsor Role: collaborator

St Peters Health Partners

UNKNOWN

Sponsor Role: collaborator

Ann Steffens Scleroderma Foundation

UNKNOWN

Sponsor Role: collaborator

Russell Sage College

OTHER

Sponsor Role: collaborator

Giovanna Fichera

OTHER

Sponsor Role: lead

Responsible Party

Giovanna Fichera

Co-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Russell Sage College

Troy, New York, United States

Countries

United States

Central Contacts

Christine Mulligan, OTD

Role: CONTACT

mullic@sage.edu

518-244-2266

Debra Collette, OTD

Role: CONTACT

colled@sage.edu

518-244-4591

Facility Contacts

Christine Mulligan, Doctorate

Role: primary

mullic@sage.edu

518-244-4591

Debra Collette, Doctorate

Role: backup

colled@sage.edu

518-244-4591

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

21-1019-1

Identifier Type: -

Identifier Source: org_study_id