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

NCT ID: NCT06843746

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-04

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Usability Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are 2 groups: newly developed low-cost thermoplastic splint and commercial thermoplastic splint.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Experimental group

Group Type EXPERIMENTAL

Newly developed low-cost thermoplastic

Intervention Type DEVICE

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

Control group

Group Type ACTIVE_COMPARATOR

Commercial thermoplastic

Intervention Type DEVICE

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

Interventions

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Commercial thermoplastic

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

Intervention Type DEVICE

Newly developed low-cost thermoplastic

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Komsak Sinsurin

Asst.Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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MU-CIRB 2022/027.1002

Identifier Type: -

Identifier Source: org_study_id

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