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Home-Based Exercise Programs for Fall Prevention in Parkinson Disease

14 de agosto de 2026 actualizado por: Selim Mahmut GÜNAY, Uludag University

Effectiveness of Fall-Preventive Home Exercise Programs in Patients With Parkinson Disease: A Randomized Controlled Trial

Falls are common in patients with Parkinson disease and may lead to reduced mobility, fear of falling, loss of independence, and injury. Exercise-based rehabilitation programs may help improve balance, gait, and physical performance in this population.

This randomized controlled trial aims to compare the effectiveness of two home-based exercise programs in patients with Parkinson disease: the Otago Exercise Program and a structured home exercise program. Participants will be randomly assigned to one of two groups. Both groups will receive exercise education and will perform their assigned home exercise program for 6 weeks.

Participants will be evaluated at baseline, at week 3, and at the end of week 6. The study will assess fall-related outcomes, freezing of gait, functional mobility, gait parameters, postural control, and physical performance. The results may help determine which home-based exercise approach is more effective for reducing fall risk and improving functional outcomes in patients with Parkinson disease.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

28

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

    • Antakya
      • Hatay, Antakya, Turquía (Türkiye)
        • Hatay Mustafa Kemal University

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Diagnosis of Parkinson disease confirmed by a neurologist
  • Hoehn and Yahr stage 3 or 4 Parkinson disease
  • Diagnosis of Parkinson disease for at least 5 years
  • Willingness to participate in the study and provide written informed consent
  • Ability to walk independently or with minimal assistance
  • Mini-Mental State Examination score >24

Exclusion Criteria:

  • Balance or gait impairment due to causes other than Parkinson disease, such as severe orthopedic problems or another neurological disease
  • Red flags suggestive of Parkinson-plus syndromes, such as symmetric onset, early falls, early-onset dementia, or gaze palsy
  • History of serious fall-related injury or surgery within the last 6 months
  • Any additional health condition that would prevent participation in the exercise program during the study period

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
Experimental: Otago Home Exercise Program
Participants in this arm will receive the Otago Home Exercise Program. The program includes home-based strengthening, static balance, and dynamic balance exercises designed to improve lower extremity muscle strength, balance, functional mobility, and fall-related outcomes. Participants will perform the exercises 3 times per week for 6 weeks, with each session lasting approximately 40 minutes. The exercise program will be reviewed and progressed at week 3 according to the participant's functional status.
nce exercises designed to improve lower extremity muscle strength, balance, functional mobility, and fall-related outcomes. Participants will perform the program 3 times per week for 6 weeks, with each session lasting approximately 40 minutes. The program will be reviewed and progressed at week 3.
Comparador activo: Structured Home Exercise Program
Participants in this arm will receive a structured home exercise program. The program includes spinal stabilization exercises and stretching and strengthening exercises targeting the ankle plantar flexor and dorsiflexor muscles, quadriceps, lumbar extensor muscles, pectoral muscles, and hamstring muscles. Participants will perform the exercises 3 times per week for 6 weeks, with each session lasting approximately 40 minutes. The exercise program will be reviewed and progressed at week 3 according to the participant's functional status.
The structured home exercise program is a home-based exercise intervention including spinal stabilization exercises and stretching and strengthening exercises targeting the ankle plantar flexor and dorsiflexor muscles, quadriceps, lumbar extensor muscles, pectoral muscles, and hamstring muscles. Participants will perform the program 3 times per week for 6 weeks, with each session lasting approximately 40 minutes. The program will be reviewed and progressed at week 3.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Freezing of Gait Questionnaire (FOGQ)
Periodo de tiempo: Baseline, week 3, and week 6
Freezing of gait will be assessed using the Freezing of Gait Questionnaire (FOGQ). The FOGQ evaluates the severity of freezing episodes and their impact on walking performance in patients with Parkinson disease. The total score ranges from 0 to 24. Higher scores indicate more severe freezing of gait and worse walking performance.
Baseline, week 3, and week 6

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Falls Efficacy Scale
Periodo de tiempo: Baseline, week 3, and week 6
Fall-related self-efficacy and fear of falling will be assessed using the Falls Efficacy Scale. The scale evaluates the participant's confidence in performing daily activities without falling. Scores range from 10 to 100, with lower scores indicating greater fear of falling and higher scores indicating lower fear of falling.
Baseline, week 3, and week 6
Timed Up and Go Test
Periodo de tiempo: Baseline, week 3, and week 6
r, walk a short distance, turn, walk back, and sit down. The time required to complete the test will be recorded in seconds, with longer times indicating poorer functional mobility.
Baseline, week 3, and week 6
Functional Reach Test
Periodo de tiempo: Baseline, week 3, and week 6
The Functional Reach Test will be used to assess dynamic balance and postural control. The maximum distance the participant can reach forward while standing without losing balance will be recorded in centimeters. Greater reach distance indicates better functional balance.
Baseline, week 3, and week 6
Sit-to-Stand Test
Periodo de tiempo: Baseline, week 3, and week 6
The sit-to-stand task will be used to assess functional lower extremity performance and postural control during transition from sitting to standing. The time required to complete the movement will be recorded in seconds using video-based analysis.
Baseline, week 3, and week 6
Gait Initiation Time
Periodo de tiempo: Baseline, week 3, and week 6
Gait initiation time will be assessed using video-based kinematic analysis. The time from the auditory cue to the initiation of the first step will be recorded in seconds. Longer times indicate impaired gait initiation.
Baseline, week 3, and week 6

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)

8 de febrero de 2026

Finalización primaria (Actual)

1 de julio de 2026

Finalización del estudio (Actual)

1 de agosto de 2026

Fechas de registro del estudio

Enviado por primera vez

10 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de mayo de 2026

Publicado por primera vez (Actual)

15 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de agosto de 2026

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

14 de agosto de 2026

Última verificación

1 de agosto 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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