Comparison of Usability Satisfaction of the Newly Developed Low-cost Thermoplastic Splint and Commercial Thermoplastic Splint

Comparison of Usability Satisfaction of the Newly Developed Low-cost Thermoplastic Splint and Commercial Thermoplastic Splint in Orthopedic Patients.

Low-temperature thermoplastic has been commonly used in the fabrication of hand splints. However, its high cost and limited accessibility pose challenges for both clinicians and clients. There is a need for innovative and cost-effective splinting materials that are convenient to use. This study aimed to investigate the satisfaction and opinions of patients regarding a newly developed low-cost thermoplastic material.

Study Overview

• Status: Completed
• Conditions: Usability Satisfaction
• Intervention / Treatment: Device: Newly developed low-cost thermoplastic; Device: Commercial thermoplastic

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Nakhon Pathom
    • Salaya, Nakhon Pathom, Thailand, 73170
      • Faculty of Physical Therapy, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient with musculoskeletal disorder
• Need to receive the splint from occupational therapist

Exclusion Criteria:

• History of neurological disorder
• Have the cognitive impairment
• Receive the splint already
• Have clinical diagnosis of the disease or symptoms that cannot use the splint

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Device: Commercial thermoplastic; The participants received a commercial thermoplastic splint material for splint fabrication.
Experimental: Experimental group	Device: Newly developed low-cost thermoplastic; The participants received a newly developed low-cost thermoplastic splint material for splint fabrication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction and opinions	An online questionnaire and Zoom Interview were utilized to collect the data on the satisfaction and opinions of orthopedic patients regarding the use of thermoplastic.	After using the thermoplastic splint for 3 days

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Occupational Therapy; Splinting Materials; Low temperature thermoplastic; Hand splint
• Other Study ID Numbers: MU-CIRB 2022/027.1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No