- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07828392
Isolated Gastrocnemius Tightness and Tactile Sensitivity
Plantar Tactile Sensitivity Individuals With Isolated Gastrocnemius Tightness
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Niğde, Turquía (Türkiye)
- Nigde Omer Halisdemir University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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 |
|
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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Ankle Dorsiflexion Index
Periodo de tiempo: 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
|
|
Assessment of postural control
Periodo de tiempo: 6 months
|
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.
|
6 months
|
|
Plantar tactile sensitivity
Periodo de tiempo: 6 months
|
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.
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rabia ZORLULAR, Nigde Omer Halisdemir University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Isolated Gastrocnemius
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .