- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07828392
Isolated Gastrocnemius Tightness and Tactile Sensitivity
Plantar Tactile Sensitivity Individuals With Isolated Gastrocnemius Tightness
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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Niğde, Turquie (Türkiye)
- Nigde Omer Halisdemir University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Adults aged 18-65 with or without isolated gastrocnemius tightness,
- Individuals able to walk without experiencing pain
Exclusion Criteria:
- Presence of neuromuscular disease,
- Conditions affecting plantar tactile sensation, such as diabetes,
- History of prior surgical procedures distal to the knee joint,
- Any current or previous symptoms related to the foot or ankle region,
- Presence of joint hypermobility,
- Individuals who do not volunteer.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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individuals with isolated gastrocnemius tightness
The difference between the mean dorsiflexion values obtained with the knee flexed at a minimum of 20° and in full extension will be calculated as the Ankle Dorsiflexion Index (ADI): •Ankle Dorsiflexion Index = Dorsiflexion with knee at 20° flexion - Dorsiflexion with knee in full extension The threshold value of ADI ≥10°, commonly used in the literature for classifying isolated gastrocnemius tightness, will be taken into account. |
First, the participant will be asked to move their knee forward-while keeping the heel of the tested foot in full contact with the ground and the foot aligned forward-until reaching the maximum dorsiflexion position possible without the heel lifting off the ground. Ankle dorsiflexion range of motion will be measured with the knee flexed at a minimum of 20°. Subsequently, the same assessment will be repeated with the knee in full extension (0°). Under both conditions, the maximum angular change occurring during the forward movement of the tibia relative to the starting position will be recorded as the ankle dorsiflexion range of motion. The difference between the mean dorsiflexion values obtained with the knee flexed at a minimum of 20° and in full extension will be calculated as the Ankle Dorsiflexion Index |
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individuals without isolated gastrocnemius tightness
The difference between the mean dorsiflexion values obtained with the knee flexed at a minimum of 20° and in full extension will be calculated as the Ankle Dorsiflexion Index: For individuals without isolated gastrocnemius tightness, a threshold value of <10° for the Ankle Dorsiflexion Index will be considered. |
First, the participant will be asked to move their knee forward-while keeping the heel of the tested foot in full contact with the ground and the foot aligned forward-until reaching the maximum dorsiflexion position possible without the heel lifting off the ground. Ankle dorsiflexion range of motion will be measured with the knee flexed at a minimum of 20°. Subsequently, the same assessment will be repeated with the knee in full extension (0°). Under both conditions, the maximum angular change occurring during the forward movement of the tibia relative to the starting position will be recorded as the ankle dorsiflexion range of motion. The difference between the mean dorsiflexion values obtained with the knee flexed at a minimum of 20° and in full extension will be calculated as the Ankle Dorsiflexion Index |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Ankle Dorsiflexion Index
Délai: 6 months
|
First, the participant will be asked to move their knee forward-while keeping the heel of the tested foot in full contact with the ground and the foot aligned forward-until reaching the maximum dorsiflexion position possible without the heel lifting off the ground. Ankle dorsiflexion range of motion will be measured with the knee flexed at a minimum of 20°. Subsequently, the same assessment will be repeated with the knee in full extension (0°). Under both conditions, the maximum angular change occurring during the forward movement of the tibia relative to the starting position will be recorded as the ankle dorsiflexion range of motion. The difference between the mean dorsiflexion values obtained with the knee flexed at a minimum of 20° and in full extension will be calculated as the Ankle Dorsiflexion Index |
6 months
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Assessment of postural control
Délai: 6 months
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Postural control will be assessed using a force plate (KINVENT, France).
Data will be transmitted to the force plate application via a Bluetooth connection.
Prior to the actual measurements, participants will be informed about the force platform and the test conditions, and a practice trial will be conducted to familiarize them with the tests.
Static postural control will be assessed under three different conditions: (1) standing on both feet with eyes open, (2) standing on both feet with eyes closed, and (3) standing on one foot with eyes open.
In the assessment of postural control, the primary Center of Pressure parameters-mean Center of Pressure velocity, Center of Pressure path length, and sway area-were evaluated.
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6 months
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Plantar tactile sensitivity
Délai: 6 months
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Plantar tactile sensitivity will be assessed using Semmes-Weinstein monofilaments.
During the assessment, participants will be positioned prone, with their feet hanging freely off the edge of the examination table and not touching any surface.
The assessment will begin with the monofilament that applies the lowest force, and the procedure will progress to progressively thicker monofilaments until the participant perceives the stimulus.
The lowest Semmes-Weinstein monofilament value perceived in these areas will be recorded as the plantar tactile sensation threshold.
Lower perceived pressure values indicate higher tactile sensitivity in the sole of the participant's foot.
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6 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Rabia ZORLULAR, Nigde Omer Halisdemir University
Publications et liens utiles
Publications générales
- MARINACCIO L. [Frequency and clinical and histological significance of diseases of the uterus; critical and statistical observations on biopsies]. G Clin Med. 1953 Jul;34(7):788-823. No abstract available. Undetermined Language.
- DeBack V. We have a part to play in changing the world: a conversation with Dr Vivien DeBack. Int Nurs Rev. 2002 Dec;49(4):199-201. doi: 10.1046/j.1466-7657.2002.00150.x. No abstract available.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Isolated Gastrocnemius
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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