NCT06584968

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 5, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

September 10, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

October 22, 2024

Status Verified

September 1, 2024

Enrollment Period

1 month

First QC Date

August 21, 2024

Last Update Submit

October 18, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Application duration of the Semmes-Weinstein Monofilament Test

    The application duration of the Semmes-Weinstein Monofilament Test will be recorded in seconds.

    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.

    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.

    just before the intervention and just after completion of the intervention

Study Arms (2)

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.

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.

Other: classical learning

Interventions

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.

Training with visual feedback

Study of the test with practical applications on the researcher who plays the role of the patient

Classical learning

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Feedback, Sensory

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalFeedback, PhysiologicalHomeostasisPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2024

First Posted

September 5, 2024

Study Start

September 10, 2024

Primary Completion

October 15, 2024

Study Completion

October 15, 2024

Last Updated

October 22, 2024

Record last verified: 2024-09

Locations