Artificial Intelligence Based Autonomous Socket Proposal Program: Socket Design Experiences

NCT05341674 | Completed

• 1 other identifier: MAC2022
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to develop an artificial intelligence-based autonomous socket recommendation program that will provide a more comfortable and easier test socket production with high time-cost efficiency and to share experiences about socket designs in these processes.

Conditions

Artificial Intelligence; Prosthetic

Outcome Measures

Primary Outcomes (1)

• Software ( Artificial Intelligence Based Autonomous Socket Proposal Program)

  The foresight of the software to be developed will be evaluated. It will be evaluated how suitable a socket design can be suggested for the stump dimensions entered into the system. Thanks to the software, the time taken for socket design will be compared with the time taken for sockets produced with classical methods. The time/cost effectiveness of the software will be evaluated.

  2 years

Study Arms (2)

Model of the stump scanned with a 3d scanner

For the artificial intelligence-based software planned to be created, the stumps of all patients were scanned with the Artec Eva Lite brand 3D scanner. The scanned patterns were saved as point clouds

Other: the stumps of all patients were scanned with the Artec Eva Lite brand 3D scanner.

Socket matched to stump

The socket parts of the prostheses used by the same patients (with other group) were also scanned with the same scanner device and recorded.

Interventions

the stumps of all patients were scanned with the Artec Eva Lite brand 3D scanner. OTHER

the stumps of all patients were scanned with the Artec Eva Lite brand 3D scanner.

Model of the stump scanned with a 3d scanner

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged between 18-45 years with amputation who came to Hasan Kalyoncu University and who met the inclusion criteria of the study.

You may qualify if:

• \- Conscious patients \>18 years old having undergone amputation surgery

You may not qualify if:

• Severe visual and perception impairment
• Surgical intervention with functional sequelae in the extremities
• Pain that does not allow tests to be done
• Patients with diseases with neurological dysfunction (stroke, multiple sclerosis, etc.)

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Şahinbey, 27000, Turkey (Türkiye)

Location

Related Publications (4)

• Ten Kate J, Smit G, Breedveld P. 3D-printed upper limb prostheses: a review. Disabil Rehabil Assist Technol. 2017 Apr;12(3):300-314. doi: 10.1080/17483107.2016.1253117. Epub 2017 Feb 2.

  PMID: 28152642 RESULT

• O'Brien L, Cho E, Khara A, Lavranos J, Lommerse L, Chen C. 3D-printed custom-designed prostheses for partial hand amputation: Mechanical challenges still exist. J Hand Ther. 2021 Oct-Dec;34(4):539-542. doi: 10.1016/j.jht.2020.04.005. Epub 2020 Jun 19.

  PMID: 32565103 RESULT

• Vujaklija I, Farina D. 3D printed upper limb prosthetics. Expert Rev Med Devices. 2018 Jul;15(7):505-512. doi: 10.1080/17434440.2018.1494568. Epub 2018 Jul 5.

  PMID: 29949397 RESULT

• Abbady HEMA, Klinkenberg ETM, de Moel L, Nicolai N, van der Stelt M, Verhulst AC, Maal TJJ, Brouwers L. 3D-printed prostheses in developing countries: A systematic review. Prosthet Orthot Int. 2022 Feb 1;46(1):19-30. doi: 10.1097/PXR.0000000000000057.

  PMID: 34772868 RESULT

Study Officials

• Murat ÇINAR, Doctor

  Hasan Kalyoncu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD,

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 22, 2022
• Study Start: January 1, 2020
• Primary Completion: June 10, 2021
• Study Completion: March 1, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)