- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07717593
Assessment Tactile Sensory Function (Tactile Sense)
16 juli 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
121
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Istanbul, Turkiet (Türkiye), 34280
- Istanbul Arel University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Testmetod
Sannolikhetsprov
Studera befolkning
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.
Beskrivning
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.
-
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Young adults
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Tactile Sensation normative values
Tidsram: 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
|
june 2022-January 2023
|
|
the normative data of the monofilament test of the lower extremity in the healthy, young Turkish population.
Tidsram: 01 June 2022- 15 Jan 2023
|
the normative data of the monofilament test of the lower extremity in the healthy, young Turkish population.
|
01 June 2022- 15 Jan 2023
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gender
Tidsram: 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.
|
June 2022-January 2023
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2022
Primärt slutförande (Faktisk)
15 januari 2023
Avslutad studie (Faktisk)
20 januari 2023
Studieregistreringsdatum
Först inskickad
16 juli 2026
Först inskickad som uppfyllde QC-kriterierna
16 juli 2026
Första postat (Faktisk)
21 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- IstanbulArelUniversity
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .