Usability SatisfactionNCT06843746
Comparison of Usability Satisfaction of the Newly Developed Low-cost Thermoplastic Splint and Commercial Thermoplastic Splint
A study testing Commercial thermoplastic and Newly developed low-cost thermoplastic in people with Usability Satisfaction, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Usability Satisfaction
- What is being tested?
- Commercial thermoplastic and Newly developed low-cost thermoplastic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteThailand
- Study dates
- 4 Feb 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient with musculoskeletal disorder
- Need to receive the splint from occupational therapist
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Physical Therapy, Mahidol University
Salaya, Changwat Nakhon Pathom, 73170
About this study
Official title: 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.
- Conditions
- Usability Satisfaction
- Being tested
- Commercial thermoplastic, Newly developed low-cost thermoplastic
- Keywords
- Splinting Materials, Low temperature thermoplastic, Hand splint, Occupational Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial thermoplasticDevice
The participants received a commercial thermoplastic splint material for splint fabrication.
Newly developed low-cost thermoplasticDevice
The participants received a newly developed low-cost thermoplastic splint material for splint fabrication.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Device: Newly developed low-cost thermoplastic |
| Control group | Active comparator | Not described Receives: Device: Commercial thermoplastic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After using the thermoplastic splint for 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start4 Feb 2022
- Primary completion30 Apr 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Usability SatisfactionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 groups: newly developed low-cost thermoplastic splint and commercial thermoplastic splint.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Komsak Sinsurin, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843746
- Sponsor's protocol ID
- MU-CIRB 2022/027.1002
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Usability Satisfaction of the Newly Developed Low-cost Thermoplastic Splint and Commercial Thermoplastic Splint in Orthopedic Patients.
- ClinicalTrials.gov ID
- NCT06843746
- Acronym / sponsor ID
- MU-CIRB 2022/027.1002
- Conditions
- Usability Satisfaction
- Keywords
- Splinting Materials, Low temperature thermoplastic, Hand splint, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- There are 2 groups: newly developed low-cost thermoplastic splint and commercial thermoplastic splint.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Newly developed low-cost thermoplastic |
| Control group | Active comparator | Device: Commercial thermoplastic |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient with musculoskeletal disorder
- Need to receive the splint from occupational therapist
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercial thermoplasticThe participants received a commercial thermoplastic splint material for splint fabrication. | Device | Control group |
| Newly developed low-cost thermoplasticThe participants received a newly developed low-cost thermoplastic splint material for splint fabrication. | Device | Experimental group |
Primary outcome
Patient satisfaction and opinions
Time frame: After using the thermoplastic splint for 3 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercial thermoplastic and Newly developed low-cost thermoplastic in people with Usability Satisfaction, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction and opinions (time frame: After using the thermoplastic splint for 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.