Arthritis, Osteoarthritis Hand, Rheumatoid Arthritis, Scleroderma, Diffuse, Scleroderma, Systemic
Conditions
Keywords
Splints, Occupational Therapy, Hand, Printing, Three-Dimensional, Contracture, Rheumatology, Ulcer, Orthotic Devices, Range of Motion, Articular
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.
Interventions
OTHERCustom Fabricated Splint
Participants will wear a customized splint on their affected hand(s)during the hours of sleep for the duration of the study.
Sponsors
Precision Valve Automation
St Peters Health Partners
Ann Steffens Scleroderma Foundation
Russell Sage College
Giovanna Fichera
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in range of motion of the hand (measured with a goniometer) | During the initial visit (two weeks before the intervention begins) and again during the second clinical visit (the day before the intervention begins) | The active range of motion of the participant's affected forearm, wrist, and fingers will be assessed with a goniometer. A change in range of motion across two weeks is being assessed (before the intervention begins). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hours of sleep measured through a survey | During the initial visit (two weeks before the intervention begins) and during the second clinical visit (the day before the intervention begins) | Participants will log their hours of sleep and hours they wear their splint each night to determine if they are able to sleep longer when wearing the splint compared to before they wore the splint. This data will be tracked to ensure the intervention is not decreasing hours of sleep significantly. The change in hours of sleep across two weeks (before the intervention begins) will be assessed. |
| Disability of the Arm, Shoulder, and Hand Questionnaire | One time before the intervention begins (During the initial visit) | Self-administered outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. This will be used to assess the participant's ability to complete occupation based tasks with their affected hand. |
| Change of reported comfort level (in hand) measured through a survey | During the initial visit (two weeks before the intervention begins) and again during the second clinical visit (the day before the intervention begins) | Patients will document their perceived comfort level in their affected hand in a questionnaire twice, across two weeks, before the study intervention begins. The scale is 0-10. 0 being least uncomfortable to 10 being very comfortable. The change in comfort across two weeks is being assessed before the intervention begins. |
| Change in the number of patients with intact skin integrity of the hands through photographs | Every other week throughout the intervention period, a total of three times during the intervention which is six weeks long. | Photographs of the wrist and hand will be taken to assess the skin integrity of the hand that is wearing the splint. Intact skin integrity is indicated by the absence of ulcers, sores, and redness. |
| Patient satisfaction with splinting process - Individual Interview | Half way through the six week intervention period the participants will be interviewed (at week three) | The participants will complete a brief 15 minute interview to assess their overall satisfaction with the novel splinting method and splinting intervention. The interview will occur via Zoom or phone call. The participant will answer the following questions: 1. How do you feel the scanning process went? 2. Were you uncomfortable at all throughout the scanning process? (ie. Did your arm feel discomfort at any point? If so on a scale from 0-10 what was the discomfort level?) 3. How do you feel the splint intervention is going? 4. Do you have any questions or concerns? |
| Number of patients with intact skin integrity of the hands through photographs | Photographs of the hand will be taken one day before the six week intervention begins | Photographs of the wrist and hand will be taken to assess the skin integrity of the hand that is wearing the splint. Intact skin integrity is indicated by the absence of ulcers, sores, and redness. |
Countries
United States
Contacts
Primary ContactChristine Mulligan, OTD
Backup ContactDebra Collette, OTD
Outcome results
None listed