- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07575425
Effects of Mobilized Balance Platform Exercises on Balance Parameters in Patients With Knee Osteoarthritis
Effects of Mobilized Balance Platform Exercises on Balance Parameters, Functional Status, and Pain in Patients With Knee Osteoarthritis: A Randomized Controlled Trial
This prospective single-blind randomized controlled study aims to investigate the effects of mobilized balance platform exercises on balance parameters, pain, functional status, fear of falling, and kinesiophobia in patients with knee osteoarthritis. A total of 36 patients diagnosed with knee osteoarthritis will be recruited from the outpatient clinic of Gaziler Physical Medicine and Rehabilitation Training and Research Hospital.
Participants will be randomly assigned to one of two groups. The control group will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program consisting of knee strengthening, balance, range of motion, proprioceptive, and stretching exercises. The intervention group will receive the same conventional treatment in addition to mobilized balance platform exercises using the Huber 360 system.
Pain severity, functional status, balance parameters, fear of falling, and kinesiophobia will be evaluated before and after treatment by an assessor blinded to treatment allocation.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sefa Gumruk Aslan
- Número de teléfono: +903122911503
- Correo electrónico: sefagumrukk@gmail.com
Ubicaciones de estudio
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Ankara, Turquía (Türkiye)
- Reclutamiento
- Gaziler physical therapy and rehabilitation
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Contacto:
- Sefa Gumruk Aslan
- Número de teléfono: +903122911503
- Correo electrónico: sefagumrukk@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients aged between 45 and 65 years
- Diagnosis of knee osteoarthritis classified as Kellgren-Lawrence grade 2 or 3
- Willingness to participate voluntarily in the study
Exclusion Criteria:
- Presence of orthopedic knee implants
- Kellgren-Lawrence grade 1 or grade 4 knee osteoarthritis
- Sensory impairment
- Diagnosis of malignancy
- Unhealed fractures
- Circulatory disorders
- Infection around the knee joint
- Severe hearing loss or visual impairment
- Cognitive impairment
- Uncontrolled hypertension or diabetes mellitus
- Vestibular disorders causing balance problems, such as vertigo
- Use of walking assistive devices such as canes or walkers
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 |
|---|---|
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Comparador activo: Conventional Physical Therapy
Participants in this group will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program.
The home exercise program will include knee strengthening, balance, range of motion, proprioceptive, and stretching exercises, performed 3 days per week for 20 minutes.
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Participants will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program consisting of knee strengthening, balance, range of motion, proprioceptive, and stretching exercises performed 3 times per week for 20 minutes.
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Experimental: Mobilized Balance Platform Exercise
Participants in this group will receive conventional physical therapy including TENS in addition to mobilized balance platform exercises using the Huber 360 system.
The exercise protocol will include quadriceps and core strengthening, proprioceptive, balance, and neuromuscular exercises, performed 3 days per week for 20 minutes.
|
Participants will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program consisting of knee strengthening, balance, range of motion, proprioceptive, and stretching exercises performed 3 times per week for 20 minutes.
Participants will perform mobilized balance platform exercises using the Huber 360 system.
The exercise protocol will include quadriceps and core strengthening, proprioceptive training, balance exercises, and neuromuscular exercises specifically designed for patients with knee osteoarthritis.
Sessions will be performed 3 times per week for 20 minutes.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Static and Dynamic Balance Parameters
Periodo de tiempo: Before treatment and immediately after completion of the 8-week treatment program
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Balance performance will be assessed using the Huber 360 balance assessment system.
Measurements will include static balance with eyes open and eyes closed, single-leg balance performance, and limits of stability.
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Before treatment and immediately after completion of the 8-week treatment program
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Severity Assessed by Visual Analog Scale (VAS)
Periodo de tiempo: Before treatment and immediately after completion of the 8-week treatment program
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Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) for night pain, resting pain, and pain during movement.
Higher scores indicate greater pain severity.
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Before treatment and immediately after completion of the 8-week treatment program
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Functional Status Assessed by WOMAC
Periodo de tiempo: Before treatment and immediately after completion of the 8-week treatment program
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Functional status will be evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Higher scores indicate worse pain, stiffness, and functional limitation.
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Before treatment and immediately after completion of the 8-week treatment program
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Functional Mobility Assessed by Timed Up and Go Test
Periodo de tiempo: Before treatment and immediately after completion of the 8-week treatment program
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Functional mobility and dynamic balance will be assessed using the Timed Up and Go Test.
Shorter completion times indicate better functional mobility.
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Before treatment and immediately after completion of the 8-week treatment program
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Fear of Falling Assessed by the International Falls Efficacy Scale
Periodo de tiempo: Before treatment and immediately after completion of the 8-week treatment program
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Fear of falling during activities of daily living will be evaluated using the International Falls Efficacy Scale.
Higher scores indicate greater concern about falling.
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Before treatment and immediately after completion of the 8-week treatment program
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Kinesiophobia Assessed by Tampa Scale for Kinesiophobia
Periodo de tiempo: Before treatment and immediately after completion of the 8-week treatment program
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Fear of movement and reinjury will be evaluated using the Tampa Scale for Kinesiophobia.
Higher scores indicate greater fear of movement.
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Before treatment and immediately after completion of the 8-week treatment program
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Sefa Gümrük Aslan, gaziler physcial therapy and rehabilitation hospital
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KOA-MBP-2026
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.
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