Novel Splinting Technique Using 3D Models

Rheumatoid Arthritis Clinical Trial

Official title:

Implementing a Novel Splinting Technique Using 3D Models for Patients With Scleroderma and Arthritis: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05351060
• Other study ID #: 21-1019-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: August 19, 2022

Study information

• Verified date: April 2022
• Source: Russell Sage College
• Contact: Christine Mulligan, OTD
• Phone: 518-244-2266
• Email: mullic[@]sage.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: August 19, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Osteoarthritis Hand
• Rheumatoid Arthritis
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Russell Sage College	Troy	New York

Sponsors (5)

Lead Sponsor	Collaborator
Giovanna Fichera	Ann Steffens Scleroderma Foundation, Precision Valve Automation, Russell Sage College, St Peters Health Partners

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in range of motion of the hand (measured with a goniometer)	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).	During the initial visit (two weeks before the intervention begins) and again during the second clinical visit (the day before the intervention begins)
Primary	Change in range of motion of the hand (measured with a goniometer)	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 the six week intervention period will be assessed.	Every other week throughout the intervention period, a total of three times during the intervention which is six weeks long.
Secondary	Change of reported comfort level (in hand) measured through a survey	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.	During the initial visit (two weeks before the intervention begins) and again during the second clinical visit (the day before the intervention begins)
Secondary	Change of reported comfort level (in hand) measured through a survey	Patients will report their perceived comfort level in their hand each morning after wearing the splint in an online or hard copy questionnaire. The scale is 0-10. 0 being least uncomfortable to 10 being very comfortable. The change in comfort in the hand across the six week intervention period is being assessed.	Daily throughout the six week intervention period
Secondary	Change in hours of sleep measured through a survey	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.	During the initial visit (two weeks before the intervention begins) and during the second clinical visit (the day before the intervention begins)
Secondary	Change in hours of sleep measured through a survey	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 the six-week intervention period will be assessed.	Daily throughout the six week intervention period
Secondary	Disability of the Arm, Shoulder, and Hand Questionnaire	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.	One time before the intervention begins (During the initial visit)
Secondary	Disability of the Arm, Shoulder, and Hand Questionnaire	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.	One time within a week of completing the six week intervention
Secondary	Number of patients with intact skin integrity of the hands through photographs	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.	Photographs of the hand will be taken one day before the six week intervention begins
Secondary	Change in the number of patients with intact skin integrity of the hands through photographs	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.	Every other week throughout the intervention period, a total of three times during the intervention which is six weeks long.
Secondary	Patient satisfaction with splinting process - Individual Interview	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: How do you feel the scanning process went?; 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?); How do you feel the splint intervention is going?; Do you have any questions or concerns?	Half way through the six week intervention period the participants will be interviewed (at week three)
Secondary	Patient satisfaction with splinting process - Individual Interview	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: How do you feel the splint intervention went? 2. What would you have wished would have been different throughout this process? 3. Do you feel as though this process was beneficial for you?	Within a week of completing the six week intervention, the participants will be interviewed