- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06584968
Improving the Application Skill of the Semmes-Weinstein Monofilament Test
October 18, 2024 updated by: Ozge Buket Arslan, Hacettepe University
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ankara, Turkey
- Hacettepe University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Training with visual feedback
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.
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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.
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Active Comparator: Classical learning
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.
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Study of the test with practical applications on the researcher who plays the role of the patient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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just before the intervention and just after completion of the intervention
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The applied force of the Semmes-Weinstein Monofilament Test
Time Frame: just before the intervention and just after completion of the intervention
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The applied force of the Semmes-Weinstein Monofilament Test will be recorded in grams.
|
just before the intervention and just after completion of the intervention
|
|
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.
|
just before the intervention and just after completion of the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2024
Primary Completion (Actual)
October 15, 2024
Study Completion (Actual)
October 15, 2024
Study Registration Dates
First Submitted
August 21, 2024
First Submitted That Met QC Criteria
September 3, 2024
First Posted (Actual)
September 5, 2024
Study Record Updates
Last Update Posted (Actual)
October 22, 2024
Last Update Submitted That Met QC Criteria
October 18, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- SWMTeaching
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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