- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07717593
Assessment Tactile Sensory Function (Tactile Sense)
16. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
121
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Istanbul, Tyrkia (Türkiye), 34280
- Istanbul Arel University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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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Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Tactile Sensation normative values
Tidsramme: 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.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Gender
Tidsramme: 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.
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June 2022-January 2023
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2022
Primær fullføring (Faktiske)
15. januar 2023
Studiet fullført (Faktiske)
20. januar 2023
Datoer for studieregistrering
Først innsendt
16. juli 2026
Først innsendt som oppfylte QC-kriteriene
16. juli 2026
Først lagt ut (Faktiske)
21. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- IstanbulArelUniversity
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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