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Completed

NCT Number: NCT07717593

Assessment Tactile Sensory Function

A total of 121 healthy volunteers (96 females, 25 males; mean age: 20,75±2,20 years) participated in this cross-sectional study conducted in the Physiotherapy and Rehabilitation Laboratory of Istanbul Arel University. Tactile sensation was assessed using the Baseline 5-piece monofilament kit in 10 specific regions of both the dominant and non-dominant lower extremities. Measurements included the tip of the hallux, medial and lateral aspects of the leg, anterior and posterior thigh, and metatarsal regions. Data were analyzed using descriptive statistics. Between-group comparisons were made using the Mann-Whitney U test. Correlations between age, body mass index (BMI), and sensation values were analyzed using Spearman's correlation coefficient.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Arel University

Istanbul, 34280, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18-25 years healthy young adults -

Exclusion criteria

if they had a history of lower limb injuries, systemic or neurological conditions, chronic pain, or skin-related issues potentially influencing tactile sensitivity, such as burns, calluses, scars, or tattoos.

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Treatment and study plan

Tactile sensation assesment by monofilament test kit

Other

The tactile sensibility of 10 predefined regions of the lower extremity was then evaluated using the Baseline brand tactile monofilament test kit, and the results were recorded. Before starting the procedure, each participant was properly positioned on an examination table first in the supine position and then in the prone position. During the assessment, the lower extremity was placed parallel to the ground. Once the participant was in a comfortable position, they were asked to close their eyes. The same examiner performed all the measurements. To minimize measurement bias, all tests were conducted by the same trained examiner under standardized environmental and procedural conditions. However, the use of a single examiner may limit inter-rater generalizability The monofilament test was applied three times to each predetermined region. Pressure was applied until the monofilament was gentlyently bent. Participants were instructed to say "yes" as soon as they perceived the stimulus, at

Primary outcomes

  1. Tactile Sensation normative values

    Time frame: june 2022-January 2023

    The tactile sensibility of 10 predefined regions of the lower extremity was then evaluated using the Baseline brand tactile monofilament test kit, and the results were recorded. Before starting the procedure, each participant was properly positioned on an examination table first in the supine position and then in the prone position. During the assessment, the lower extremity was placed parallel to the ground. Once the participant was in a comfortable position, they were asked to close their eyes. The same examiner performed all the measurements. To minimize measurement bias, all tests were conducted by the same trained examiner under standardized environmental and procedural conditions. However, the use of a single examiner may limit inter-rater generalizability.The monofilament test was applied three times to each predetermined region. Pressure was applied until the monofilament was gentlyently bent. Participants were instructed to say "yes" as soon as they perceived the stimulus, at

  2. the normative data of the monofilament test of the lower extremity in the healthy, young Turkish population.

    Time frame: 01 June 2022- 15 Jan 2023

    the normative data of the monofilament test of the lower extremity in the healthy, young Turkish population.

Secondary outcomes

  1. Gender

    Time frame: June 2022-January 2023

    The secondary outcome was to make a comparison according to gender and laterality, whether through the dominant or non-dominant sides. Before the assessment, the laboratory environment was inspected to ensure suitability.

Sponsors and collaborators

Lead sponsor

Istanbul Arel University

Other

Registry information

Official study title

Assessment of Tactile Sensory Function in the Lower Extremity of Healthy Young Individuals

Acronym: Tactile Sense

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.