Dual Task Training in Parkinson's Disease
15 de noviembre de 2019 actualizado por: Çağrı Gülşen, Gazi University
Effect of Dual Task Training on Balance, Gait, Cognition and Neurotrophic Factors in Parkinson's Disease
The aim of study is to analyze the effects of dual task training on balance, gait, cognition and neurotrophic factors in Parkinson's disease.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
20 patients diagnosed with Parkinson's disease will be randomly assigned to either intervention or control group.
And 10 healty subjects will be included to study in order to determine the reference values.The intervention group will be recieved cognitive and motor dual task training consisting of balance and walking activities 3 days a week for 8 weeks.
Control group will be recieved same balance and walking activities in single task condition 3 days a week for 8 weeks.
In order to evaluate the effects of the training, evaluations will be performed before and after the training period.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
20
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.
Ubicaciones de estudio
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Ankara, Pavo, 06560
- Reclutamiento
- Gazi University, Faculty of Health Sciences
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Contacto:
- Çağrı Gülşen
- Número de teléfono: 05555874415
- Correo electrónico: fztcagri@gmail.com
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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
40 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- at least 40 years of age
- neurologist-diagnosed Parkinson's Disease
- Hoehn & Yahr (H&Y) stages 1 to 3
- 24 or more mini mental status examination score.
Exclusion Criteria:
- other neurologic disorder
- cardiovascular, inflammatory,vestibular or musculoskeletal problems that could prevent them to participate in an exercise program
- had deep brain stimulation history
- visual, auditory, orientational problems that could affect study results
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Grupo de Intervención
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45 minutes of dual task training consisting of motor activities (walking, balance... etc.) with combination of cognitive activities (spelling words, image description, nomination, word generation, counting... etc.) at sime time.
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Comparador activo: Grupo de control
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45 minutes of single task training consisting of same motor activities (walking, balance... etc.)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Balance-Postural Stability
Periodo de tiempo: 8 weeks
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Postural Stability will be evaluated with Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).. Postural Stability test will performed on both feet and on the left and right foot separately.
Total stability index score will obtained as the test result.
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8 weeks
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Balance- Limits of Stability
Periodo de tiempo: 8 weeks
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Limits of Stability will be evaluated with Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).
Limits of Stability test assesses how much the center of gravity is displaced on the support surface without losing balance during the standing position.
Total direction control score will obtained as the test result.
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8 weeks
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Balance- Modified Sensory Organization Tests
Periodo de tiempo: 8 weeks
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Modified Sensory Organization Tests will be evaluated Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).
MSOT assesses the effects of somatosensory, visual and vestibular senses on postural control during the standing position.
It evaluates the sensory component of balance in two different visual conditions and on two different support surfaces; condition 1: eyes open-firm surface, condition 2: eyes closed-firm surface, condition 3: eyes open-foam surface and condition 4: eyes closed-foam surface.
Stability index scores will obtained as the test result.
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8 weeks
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Gait Speed
Periodo de tiempo: 8 weeks
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Gait speed will be evaluated by using the BTS-G Walk system and recorded as m/min.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Cadence
Periodo de tiempo: 8 weeks
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Cadence will be evaluated by using the BTS-G Walk system and recorded as strides/min.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Stride width
Periodo de tiempo: 8 weeks
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Stride width will be evaluated by using the BTS-G Walk system and recorded as meters.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Stride length
Periodo de tiempo: 8 weeks
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Stride length will be evaluated by using the BTS-G Walk system and recorded as meters.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: 8 weeks
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Montreal Cognitive Assessment (MoCA) will be used in order to evaluate cognition.
It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.It' score ranged from 0 to 30 and higher points indicates better cognitive outcomes.
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8 weeks
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Change in brain derived neurotrophic factor (BDNF) levels of serum
Periodo de tiempo: 8 weeks
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Brain derived neurotrophic factor (BDNF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
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8 weeks
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Change in vascular endothelial growth factor (VEGF) levels of serum
Periodo de tiempo: 8 weeks
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Vascular endothelial growth factor (VEGF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
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8 weeks
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Change in insulin like growth factor 1 (IGF-1) levels of serum
Periodo de tiempo: 8 weeks
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Insulin like growth factor 1 (IGF-1) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
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8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Hoehn and Yahr Scale for level of physical disability in Parkinson's disease.
Periodo de tiempo: 8 weeks
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Hoehn and Yahr Scale is measures level of physical disability in Parkinson's disease and stages patients between level 1 level 5. Higher level indicates worse physical condition.
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8 weeks
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Unified Parkinson's Disease Rating Scale (UPDRS)
Periodo de tiempo: 8 weeks
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The Unified Parkinson's Disease Rating Scale (UPDRS) is a widely used measure of impairment and disability associated with Parkinson's Disease (PD) consisting of four sections: (1) Mentation, behavior, and mood; (2) Activities of daily living (ADLs); (3) Motor; and (4) Complications.Sections I through III are scored using a 5-point Likert-type scale (0 = no impairment; 4 = marked impairment).
Although individual sections are scored and reported independently, scores from sections I through III are also summed to provide a UPDRS Total score.
The UPDRS total score ranges between 0 and 199 points.
Higher points indicates worse outcome.
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8 weeks
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Berg Balance Scale (BBS)
Periodo de tiempo: 8 weeks
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Berg Balance Scale (BBS) is a scale that using for assess postural stability.
It ranges 0-56 with higher score indicates better stability.
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8 weeks
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One-legged Stance Test
Periodo de tiempo: 8 weeks
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The duration participant is able to maintain their balance on one leg up to will be recorded.
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8 weeks
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Timed Up and Go (TUG) test
Periodo de tiempo: 8 weeks
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Time in seconds a person needs to stand up from a chair, walk a distance of 3 meters, turn around a flag, come back and sit down again.
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8 weeks
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Activities-Specific Balance Confidence (ABC) Scale
Periodo de tiempo: 8 weeks
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Activities-specific Balance Confidence scale (ABC), to quantify the level of confidence in performing a specific task without losing balance or becoming unsteady.
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8 weeks
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Stroop Test
Periodo de tiempo: 8 weeks
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Stroop test will be used to test cognitive function.
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8 weeks
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Trail Making Test (TMT) Part A and B
Periodo de tiempo: 8 weeks
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The Trail Making Test is a measure of attention, speed and mental flexibility.
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8 weeks
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Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8)
Periodo de tiempo: 8 weeks
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The short-form 8-item Parkinson's disease Questionnaire (PDQ-8) is the most commonly used scale measuring health related quality of life (HRQoL) in PD patients.
It includes 8 items, and each item has five options (never, occasionally, sometimes, often, always or cannot do at all).
The total score ranges from 0 to 32.
Higher scores indicates poorer quality of life.
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8 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
16 de octubre de 2019
Finalización primaria (Anticipado)
30 de marzo de 2021
Finalización del estudio (Anticipado)
30 de junio de 2021
Fechas de registro del estudio
Enviado por primera vez
30 de septiembre de 2019
Primero enviado que cumplió con los criterios de control de calidad
2 de octubre de 2019
Publicado por primera vez (Actual)
4 de octubre de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de noviembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
15 de noviembre de 2019
Última verificación
1 de noviembre de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 14.01.2019/35
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. .