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Effect of Physical Activity on the Course of Parkinson's Disease in Patients With Bilateral DBS-STN Stimulation. (EPA-DBS)

1 de octubre de 2026 actualizado por: Medical University of Warsaw

Effect of Physical Activity on the Course of Parkinson's Disease in Patients With Bilateral DBS-STN Stimulation - a Randomized Controlled Trial.

Parkinson's disease is a common, progressive neurodegenerative disorder. The degeneration of dopaminergic neurons is associated with characteristic clinical symptoms such as tremor, rigidity, slowness of movement (bradykinesia) and postural instability. Subthalamic nucleus deep brain stimulation (DBS-STN) is a recognized and widely used method of treating advanced stages of Parkinson's disease. It improves clinical symptoms such as tremor, rigidity and slowness of movement (bradykinesia). This method has limited application for late motor and non-motor symptoms such as: akinesia, postural instability, gait, including the phenomenon of "freezing", recurrent falls, balance and dysarthria. These symptoms reduce the quality of life of patients and make them dependent on their caregivers. There is a clear need to develop additional forms of therapy that complement deep brain stimulation in controlling late motor and non-motor symptoms.

Physical activity is a commonly used and recommended form of therapy for patients with Parkinson's disease and a complement to pharmacological therapy, improving gait, balance and quality of life. However, there are no clear recommendations including patients after implantation of DBS-STN stimulators to the group undergoing physiotherapy. To this day, only one clinical trial has been registered assessing the effect of physiotherapy on balance and gait in patients with DBS-STN.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

102

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Warsaw, Polonia, 03-242
        • Reclutamiento
        • Department of Neurology, Faculty of Health Sciences, Bródnowski Mazovian Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

50 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients diagnosed with idiopathic Parkinson's disease (ICD-10:G20).
  • Patients qualified for advanced therapies using DBS-STN.
  • Grade II-IV on the Hoehn & Yahr scale.
  • Age 50-70.
  • Consent to participate in the study.

Exclusion Criteria:

  • Patients diagnosed with atypical parkinsonism.
  • Patients not eligible for advanced therapies with DBS-STN.
  • Hoehn & Yahr Grade I and V.
  • Age <50 and >70
  • Patients diagnosed with dementia syndrome (MMSE < 24/30).
  • Diseases of the osteoarticular system and muscles that make it impossible to undergo rehabilitation.
  • Severe kidney, liver and heart failure.
  • Active malignancy or malignancy diagnosed and treated within 3 years prior to the study.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador falso: Grupo de control

Direct education of the patient in the field of self-care, counseling and instruction on independent exercise, use of medical equipment or devices, also at home.

Experimental: Grupo de investigación

Assessment of the patient's functional status: 10 Meter Walk (10 MW) Test, Tinetti Test, New Freezing of Gait Questionnaire (NFOG-Q), History of Falling Questionaire, Timed up and go (TUG), TUG - countdown from 100 to 80, TUG - cup half-filled with water carried in the right and left hand, TST - 10 s standing in a tandem position, 180 Tandem Pivot Test, TWT - Tandem Walking Test, Functional Reach test, Functional strength test, TEST Six Minute Walk (6MWT), Berg Balance Scale, Treadmill Gait Analysis, Platform Stabilometry Test.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III: Motor Examination
Periodo de tiempo: 2 years

Change in the full Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III: Motor Examination, score in the full ON medication/DBS state from baseline to study completion, comparing the control and study groups, with subsequent study time points also reported. Part III assesses the severity of motor signs of Parkinson's disease. The total score ranges from 0 to 132, with 0 indicating no motor impairment and higher scores indicating greater motor impairment (i.e., a worse outcome).

2 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Tinetti Performance-Oriented Mobility Assessment (POMA)
Periodo de tiempo: 2 years

Change in the full Tinetti Performance-Oriented Mobility Assessment (POMA), also known as the Tinetti Mobility Test, total score in the ON medication/DBS state before and after study completion, comparing the control and research groups, with subsequent study time points also reported. The POMA assesses balance and gait/mobility. The total score ranges from 0 to 28 points (balance: 0-16; gait: 0-12), with higher scores indicating better mobility, gait, and balance function (i.e., a better outcome).

2 years
New Freezing of Gait Questionnaire (NFOG-Q)
Periodo de tiempo: 2 years

Change in the full New Freezing of Gait Questionnaire (NFOG-Q) total score in the ON medication/DBS state before and after study completion, comparing the control and research groups, with subsequent study time points also reported. The NFOG-Q is a patient-reported measure assessing the severity of freezing of gait and its impact on daily life in people with Parkinson's disease. The total score ranges from 0 to 28 points, with 0 indicating no freezing of gait and higher scores indicating greater severity and impact of freezing of gait (i.e., a worse outcome).

2 years
Berg Balance Scale (BBS)
Periodo de tiempo: 2 years

Change in the full Berg Balance Scale (BBS) total score in the ON medication/DBS state before and after study completion, comparing the control and research groups, with subsequent study time points also reported. The BBS is a 14-item performance-based measure of functional balance. Each item is scored from 0 to 4, giving a total score ranging from 0 to 56 points, with higher scores indicating better balance and functional performance (i.e., a better outcome).

2 years
Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: 2 years

Change in the full Montreal Cognitive Assessment (MoCA) total score in the ON medication/DBS state before and after study completion, comparing the control and research groups, with subsequent study time points also reported. The MoCA is a cognitive screening assessment of multiple cognitive domains, including executive function, visuospatial abilities, attention, memory, language, and orientation. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance (i.e., a better outcome).

2 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de septiembre de 2024

Finalización primaria (Estimado)

5 de septiembre de 2027

Finalización del estudio (Estimado)

5 de septiembre de 2028

Fechas de registro del estudio

Enviado por primera vez

17 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de septiembre de 2026

Publicado por primera vez (Actual)

24 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de octubre de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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