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

NCT06843746 | Completed

• 1 other identifier: MU-CIRB 2022/027.1002
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Usability Satisfaction

Keywords

Splinting Materials; Low temperature thermoplastic; Hand splint; Occupational Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

Device: Newly developed low-cost thermoplastic

Control group

ACTIVE COMPARATOR

Device: Commercial thermoplastic

Interventions

Commercial thermoplastic DEVICE

The participants received a commercial thermoplastic splint material for splint fabrication.

Control group

Newly developed low-cost thermoplastic DEVICE

The participants received a newly developed low-cost thermoplastic splint material for splint fabrication.

Experimental group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof.Dr.

Model Details: There are 2 groups: newly developed low-cost thermoplastic splint and commercial thermoplastic splint.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: February 4, 2022
• Primary Completion: April 30, 2024
• Study Completion: May 31, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

TH (1)