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3D model splinting intervention group for Arthritis

N/A
Waitlist Available
Research Sponsored by Giovanna Fichera
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every other week throughout the intervention period, a total of three times during the intervention which is six weeks long.
Awards & highlights

Study 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.

Eligible Conditions
  • Arthritis
  • Scleroderma
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Systemic Scleroderma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~photographs of the hand will be taken one day before the six week intervention begins
This trial's timeline: 3 weeks for screening, Varies for treatment, and photographs of the hand will be taken one day before the six week intervention begins for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in range of motion of the hand (measured with a goniometer)
Secondary outcome measures
Change in hours of sleep measured through a survey
Change in the number of patients with intact skin integrity of the hands through photographs
Change of reported comfort level (in hand) measured through a survey
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: 3D model splinting intervention groupExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Giovanna FicheraLead Sponsor
Precision Valve AutomationUNKNOWN
St Peters Health PartnersUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Novel Splinting Technique Using 3D Models
Giovanna Fichera 2022. "Novel Splinting Technique Using 3D Models". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05351060.
~3 spots leftby Apr 2025
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