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- Ensayo clínico NCT07717593
Assessment Tactile Sensory Function (Tactile Sense)
16 de julio de 2026 actualizado por: Secil OZKURT, Istanbul Arel University
Assessment of Tactile Sensory Function in the Lower Extremity of Healthy Young Individuals
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
121
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Istanbul, Turquía (Türkiye), 34280
- Istanbul Arel University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra de probabilidad
Población de estudio
8-25 years healthy young adults university students.excluded
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.
Descripción
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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Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Young adults
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Tactile Sensation normative values
Periodo de tiempo: 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
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june 2022-January 2023
|
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the normative data of the monofilament test of the lower extremity in the healthy, young Turkish population.
Periodo de tiempo: 01 June 2022- 15 Jan 2023
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the normative data of the monofilament test of the lower extremity in the healthy, young Turkish population.
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01 June 2022- 15 Jan 2023
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gender
Periodo de tiempo: June 2022-January 2023
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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.
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June 2022-January 2023
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2022
Finalización primaria (Actual)
15 de enero de 2023
Finalización del estudio (Actual)
20 de enero de 2023
Fechas de registro del estudio
Enviado por primera vez
16 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
16 de julio de 2026
Publicado por primera vez (Actual)
21 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- IstanbulArelUniversity
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .