TrainingNCT06584968
Improving the Application Skill of the Semmes-Weinstein Monofilament Test
A study testing training with visual feedback and classical learning in people with Training and Students, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The Semmes-Weinstein Monofilament Test is one of the most widely used and objective clinical tests for assessing the sense of touch. Some guides include standard instructions for the application of the Semmes-Weinstein Monofilament Test. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- training with visual feedback and classical learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2024to 15 Oct 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being third or fourth-year undergraduate students of the Occupational Therapy Department
- Completing the Hand Rehabilitation course
- Being a volunteer to participate in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving the Application Skill of Semmes-Weinstein Monofilament Test with Different Teaching Methods: a Randomized Controlled Trial
The Semmes-Weinstein Monofilament Test is one of the most widely used and objective clinical tests for assessing the sense of touch. Some guides include standard instructions for the application of the Semmes-Weinstein Monofilament Test. With monofilaments applied correctly by the instructions, patients' threshold values can be determined accurately. However, there are disagreements about the accuracy of the pressure applied by the therapist who applies the monofilament to the patient. The investigators aimed to compare the application of the Semmes-Weinstein Monofilament Test to undergraduate students of the occupational therapy department by teaching it using classical methods and visual feedback.
- Being tested
- training with visual feedback, classical learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training with visual feedbackOther
Training with visual feedback by comparing the value of the monofilament with the pressure value of the monofilament applied on the precision scale in grams.
classical learningOther
Study of the test with practical applications on the researcher who plays the role of the patient
| Study group | Role | What they receive |
|---|---|---|
| Training with visual feedback | Experimental | The students in the study group will do monofilament applications on a precision scale. They will be provided with visual feedback by comparing the value of the monofilament with the pressure value of the monofilament applied on the precision scale in grams. In this way, the students will visually experience whether they can provide the appropriate level of pressure during the application. The practice on the precision scale will continue for 15-20 minutes with the monofilaments in the Semmes-Weinstein Monofilament Test kit. Receives: Other: training with visual feedback |
| Classical learning | Active comparator | The students in the control group will do practical applications with the classical learning method, where one of the researchers plays the patient role. They will do application trials with the monofilaments in the Semmes-Weinstein Monofilament Test kit for 15-20 minutes. Receives: Other: classical learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Application duration of the Semmes-Weinstein Monofilament Test
The application duration of the Semmes-Weinstein Monofilament Test will be recorded in seconds.
Measured: just before the intervention and just after completion of the intervention
The applied force of the Semmes-Weinstein Monofilament Test
The applied force of the Semmes-Weinstein Monofilament Test will be recorded in grams.
Measured: just before the intervention and just after completion of the intervention
Intervals between the Semmes-Weinstein Monofilament Test applications
Intervals between the Semmes-Weinstein Monofilament Test applications will be recorded in seconds.
Measured: just before the intervention and just after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start10 Sep 2024
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrainingStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Çankırı Karatekin University
- Responsible party
- Principal investigator, Ozge Buket Arslan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584968
- Sponsor's protocol ID
- SWMTeaching
- Status last verified
- Sep 2024
- First submitted
- 21 Aug 2024
- Last updated
- 22 Oct 2024
- 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 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Application Skill of Semmes-Weinstein Monofilament Test with Different Teaching Methods: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06584968
- Acronym / sponsor ID
- SWMTeaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Çankırı Karatekin University
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 5 Sep 2024 (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.
The Semmes-Weinstein Monofilament Test is one of the most widely used and objective clinical tests for assessing the sense of touch. Some guides include standard instructions for the application of the Semmes-Weinstein Monofilament Test. With monofilaments applied correctly by the instructions, patients' threshold values can be determined accurately. However, there are disagreements about the accuracy of the pressure applied by the therapist who applies the monofilament to the patient. The investigators aimed to compare the application of the Semmes-Weinstein Monofilament Test to undergraduate students of the occupational therapy department by teaching it using classical methods and visual feedback.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training with visual feedback | Experimental | Other: training with visual feedbackThe students in the study group will do monofilament applications on a precision scale. They will be provided with visual feedback by comparing the value of the monofilament with the pressure value of the monofilament applied on the precision scale in grams. In this way, the students will visually experience whether they can provide the appropriate level of pressure during the application. The practice on the precision scale will continue for 15-20 minutes with the monofilaments in the Semmes-Weinstein Monofilament Test kit. |
| Classical learning | Active comparator | Other: classical learningThe students in the control group will do practical applications with the classical learning method, where one of the researchers plays the patient role. They will do application trials with the monofilaments in the Semmes-Weinstein Monofilament Test kit for 15-20 minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Being third or fourth-year undergraduate students of the Occupational Therapy Department
- Completing the Hand Rehabilitation course
- Being a volunteer to participate in the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| training with visual feedbackTraining with visual feedback by comparing the value of the monofilament with the pressure value of the monofilament applied on the precision scale in grams. | Other | Training with visual feedback |
| classical learningStudy of the test with practical applications on the researcher who plays the role of the patient | Other | Classical learning |
Primary outcome
Application duration of the Semmes-Weinstein Monofilament Test
Time frame: just before the intervention and just after completion of the intervention
The application duration of the Semmes-Weinstein Monofilament Test will be recorded in seconds.
The applied force of the Semmes-Weinstein Monofilament Test
Time frame: just before the intervention and just after completion of the intervention
The applied force of the Semmes-Weinstein Monofilament Test will be recorded in grams.
Intervals between the Semmes-Weinstein Monofilament Test applications
Time frame: just before the intervention and just after completion of the intervention
Intervals between the Semmes-Weinstein Monofilament Test applications will be recorded in seconds.
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 22 Oct 2024.
- 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 training with visual feedback and classical learning in people with Training and Students, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 0 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 22 Oct 2024. 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 Turkey (Türkiye). 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?
Application duration of the Semmes-Weinstein Monofilament Test (time frame: just before the intervention and just after completion of the intervention). The study lists 3 primary outcomes in all. 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 22 Oct 2024.