Novel Splinting Technique Using 3D Models

NCT05351060 | Unknown

• 1 other identifier: 21-1019-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (10)

• 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 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

  During the initial visit (two weeks before the intervention begins) and during the second clinical visit (the day before the intervention begins)

• 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 before the intervention begins (During the initial visit)

Study Arms (1)

3D model splinting intervention group

EXPERIMENTAL

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.

Other: Custom Fabricated Splint

Interventions

Custom Fabricated Splint OTHER

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

Also known as: Orthotic

3D model splinting intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Giovanna Fichera: lead
• Precision Valve Automation: collaborator
• St Peters Health Partners: collaborator
• Ann Steffens Scleroderma Foundation: collaborator
• Russell Sage College: collaborator

Study Sites (1)

Russell Sage College

Troy, New York, 12180, United States

Location

MeSH Terms

Conditions

Arthritis; Scleroderma, Systemic; Scleroderma, Diffuse; Arthritis, Rheumatoid; Contracture; Ulcer

Interventions

Orthotic Devices

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Rheumatic Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Central Study Contacts

Christine Mulligan, OTD

CONTACT

518-244-2266; mullic@sage.edu

Debra Collette, OTD

CONTACT

518-244-4591; colled@sage.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 28, 2022
• Study Start: May 16, 2022
• Primary Completion: July 15, 2022
• Study Completion: August 19, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)