Clinical trial NCT05351060: Novel Splinting Technique Using 3D Models
Official title: Implementing a Novel Splinting Technique Using 3D Models for Patients With Scleroderma and Arthritis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthritis
Osteoarthritis Hand
Scleroderma, Systemic
Scleroderma, Diffuse
Rheumatoid Arthritis
Keywords: Splints
Occupational Therapy, Hand
Printing, Three-Dimensional
Contracture
Rheumatology
Ulcer
Orthotic Devices
Range of Motion, Articular
Lead sponsor: Russell Sage College
Sponsor class: OTHER
Collaborators: name: Precision Valve Automation
name: St Peters Health Partners
name: Ann Steffens Scleroderma Foundation
name: Russell Sage College
First posted: 2022-04-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will include up to 10 patients with autoimmune diseases, including either scleroderma, rheumatoid arthritis, or osteoarthritis, which may include the elderly. The study will compare pre and post-evaluation measures for each individual participant through a multiple time series design.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in range of motion of the hand (measured with a goniometer)
timeFrame: During the initial visit (two weeks before the intervention begins) and again during the second clinical visit (the day before the intervention begins)
measure: Change in range of motion of the hand (measured with a goniometer)
timeFrame: Every other week throughout the intervention period, a total of three times during the intervention which is six weeks long.
Secondary outcomes:
measure: Change of reported comfort level (in hand) measured through a survey
timeFrame: During the initial visit (two weeks before the intervention begins) and again during the second clinical visit (the day before the intervention begins)
measure: Change of reported comfort level (in hand) measured through a survey
timeFrame: Daily throughout the six week intervention period
measure: Change in hours of sleep measured through a survey
timeFrame: During the initial visit (two weeks before the intervention begins) and during the second clinical visit (the day before the intervention begins)
measure: Change in hours of sleep measured through a survey
timeFrame: Daily throughout the six week intervention period
measure: Disability of the Arm, Shoulder, and Hand Questionnaire
timeFrame: One time before the intervention begins (During the initial visit)
measure: Disability of the Arm, Shoulder, and Hand Questionnaire
timeFrame: One time within a week of completing the six week intervention
measure: Number of patients with intact skin integrity of the hands through photographs
timeFrame: Photographs of the hand will be taken one day before the six week intervention begins
measure: Change in the number of patients with intact skin integrity of the hands through photographs
timeFrame: Every other week throughout the intervention period, a total of three times during the intervention which is six weeks long.
measure: Patient satisfaction with splinting process - Individual Interview
timeFrame: Half way through the six week intervention period the participants will be interviewed (at week three)
measure: Patient satisfaction with splinting process - Individual Interview
timeFrame: Within a week of completing the six week intervention, the participants will be interviewed
Other outcomes:
Locations:
city: Troy
country: United States
facility: Russell Sage College
state: New York
Study officials:
References: