- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07571122
Cognitive Training for Pain , Balance and Foot Function in Plantar Fasciitis (COG-PLANT)
Effect of Cognitive Training on Pain , Foot Function, and Balance in Patients With Planter Fasciitis : A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
and impaired balance. It is characterized by degeneration of the plantar fascia due to repetitive stress, leading to pain, especially during weight-bearing activities. In addition to local tissue pathology, alterations in neuromuscular control and sensorimotor function may contribute to persistent symptoms and functional limitations.
Recent approaches in rehabilitation have highlighted the role of cognitive training in enhancing motor control, attention, and sensorimotor integration. Cognitive training, particularly when combined with movement tasks (dual-task training), may improve postural control and functional performance by optimizing central nervous system processing. However, there is limited evidence regarding its effectiveness in patients with plantar fasciitis.
This randomized controlled trial aims to investigate the effect of cognitive training on pain intensity, functional disability, and static balance in individuals with plantar fasciitis. Participants will be randomly assigned into two groups. The experimental group will receive a cognitive training program incorporating attention-demanding and dual-task exercises integrated with functional movements plus stretching and strengthing exercises . The control group will perform a conventional stretching and strengthing exercise program targeting the plantar fascia and related lower limb musculature.
Outcome measures will include pain intensity, functional disability, and static balance. Assessments will be conducted at baseline and after completion of the intervention period.
The results of this study are expected to provide evidence on the effectiveness of cognitive training as a rehabilitation approach for improving pain, functional outcomes, and balance in patients with plantar fasciitis.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sahar M Abdelmutilibe, PHD
- Número de teléfono: N/P 0021027620061
- Correo electrónico: sahar.mowad@pt.bsu.edu.eg
Ubicaciones de estudio
-
-
-
Cairo, Egipto
- Reclutamiento
- Outpatient clinics of the Faculty of Physical Therapy, Beni Suef University
-
Contacto:
- Sahar M Abdelmutilibe, PHD
- Número de teléfono: N/P 0021027620061
- Correo electrónico: sahar.mowad@pt.bsu.edu.eg
-
Contacto:
- sahar m abdelmutilibe, PHD
- Número de teléfono: N/P 0021110374341
- Correo electrónico: saharmowad04@gmail.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged 18 to 60 years. Clinically diagnosed with plantar fasciitis by a physician or physiotherapist. Experiencing heel pain for at least 4 weeks. Ability to stand and perform basic functional and balance tests. Willingness to participate and provide informed consent. Not currently receiving other structured physical therapy or cognitive training programs during the study period.
Exclusion Criteria:
- History of lower limb surgery or fractures affecting the foot or ankle. Presence of neurological disorders affecting balance or motor control (e.g., stroke, Parkinson's disease).
Systemic inflammatory or rheumatologic conditions (e.g., rheumatoid arthritis). Severe musculoskeletal deformities of the lower limb or foot. Recent corticosteroid injection in the heel region within the last 3 months. Current participation in other structured rehabilitation or exercise programs. Pregnancy (if applicable due to balance and biomechanical changes). Inability to understand or follow instructions related to the intervention.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cognitive Training Group
Participants in this group will receive a structured cognitive training program integrated with functional movement tasks.
The training will focus on improving attention, motor control, and sensorimotor integration through dual-task and task-oriented exercises designed to enhance postural control and functional stability.
Sessions will be conducted over the intervention period with progressive difficulty based on participant performance.
|
Participants will receive a structured cognitive training program incorporating dual-task and task-oriented exercises.
The intervention focuses on enhancing attention, motor planning, and sensorimotor integration during functional activities.
Exercises are progressively advanced based on participant performance to improve postural control and functional stability.
Participants will perform a standardized stretching and strengthing program targeting the plantar fascia and associated lower limb muscles.
The intervention consists of static stretching exercises aimed at improving tissue flexibility, reducing muscle tightness, and supporting pain reduction.
Exercises will be performed in a controlled and consistent manner throughout the study period.
|
|
Experimental: stretching and strengthing exercises
Participants in this group will receive a conventional stretching and strengthing exercise program targeting the plantar fascia and related lower limb muscles.
The exercises will focus on improving flexibility and reducing tissue tightness.
Stretching will be performed in a standardized manner over the intervention period.
|
Participants will perform a standardized stretching and strengthing program targeting the plantar fascia and associated lower limb muscles.
The intervention consists of static stretching exercises aimed at improving tissue flexibility, reducing muscle tightness, and supporting pain reduction.
Exercises will be performed in a controlled and consistent manner throughout the study period.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain by VAS
Periodo de tiempo: at baseline and post treatment (4 weeks)
|
Pain intensity will be assessed using the Visual Analogue Scale (VAS), a 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Participants will be asked to rate their current level of heel pain.
|
at baseline and post treatment (4 weeks)
|
|
functional disability
Periodo de tiempo: at baseline and post treatment (4 weeks)
|
Functional disability will be assessed using the Foot Function Index (FFI), which evaluates pain, disability, and activity limitation in individuals with foot disorders.
Higher scores indicate greater disability.
|
at baseline and post treatment (4 weeks)
|
|
static balance
Periodo de tiempo: at baseline and post treatment ( 4 weeks)
|
Static balance will be assessed using a standardized balance test (e.g., single-leg stance test).
Participants will be evaluated based on their ability to maintain a stable posture for a specified duration under controlled conditions.
|
at baseline and post treatment ( 4 weeks)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sahar M Abdelmutilibe, PHD, Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Enfermedades de los pies
- Fascitis
- Fascitis Plantar
- Terapéutica
- Atención al paciente
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Rehabilitación neurológica
- Entrenamiento cognitivo
Otros números de identificación del estudio
- FPTBSURE/0112/15426 (Identificador de registro: faculty of physical therapy , Beni- Suef University)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
producto fabricado y exportado desde los 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. .