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

Mahidol University

Status: Completed

Conditions: Usability Satisfaction

Treatments: Device: Newly developed low-cost thermoplastic; Device: Commercial thermoplastic

Study type: Interventional

Funder types: Other

Identifiers

NCT06843746

MU-CIRB 2022/027.1002

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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112 participants in 2 patient groups

Experimental group

Experimental group

Treatment:

Device: Newly developed low-cost thermoplastic

Control group

Active Comparator group

Treatment:

Device: Commercial thermoplastic