Implementing a Novel Splinting Technique Using 3D Models for Patients With Scleroderma and Arthritis: A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in range of motion of the hand (measured with a goniometer)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Custom Fabricated Splint (Other)
结局指标
主要结局
Change in range of motion of the hand (measured with a goniometer)
时间窗: Every other week throughout the intervention period, a total of three times during the intervention which is six weeks long.
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.
Change in range of motion of the hand (measured with a goniometer)
时间窗: 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).
次要结局
- Change of reported comfort level (in hand) measured through a survey(Daily throughout the six week intervention period)
- Change in hours of sleep measured through a survey(Daily throughout the six week intervention period)
- Disability of the Arm, Shoulder, and Hand Questionnaire(One time within a week of completing the six week intervention)
- 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)
- Patient satisfaction with splinting process - Individual Interview(Within a week of completing the six week intervention, the participants will be interviewed)
- 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.)
- 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))
- 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))
- Disability of the Arm, Shoulder, and Hand Questionnaire(One time before the intervention begins (During the initial visit))
- Patient satisfaction with splinting process - Individual Interview(Half way through the six week intervention period the participants will be interviewed (at week three))
研究者
Giovanna Fichera
Co-Investigator
Russell Sage College