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El ensayo clínico NCT07493525 para Distrofia miotónica tipo 1, Caídas está activo, no reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Fall Frequency and Factors Affecting Dynamic Balance in Patients With Myotonic Dystrophy Type 1 41 Observacional
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07493525 es un estudio observacional para Distrofia miotónica tipo 1, Caídas. Su estado actual es: activo, no reclutando. El estudio se inició el 20 de junio de 2025, con el objetivo de reclutar a 41 participantes. Dirigido por Antalya Training and Research Hospital, se espera que finalice el 15 de junio de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 25 de marzo de 2026.
Resumen
This cross-sectional observational study aims to determine the frequency of falls in patients with myotonic dystrophy type 1 and to identify factors affecting dynamic balance. The study will also evaluate fear of falling, selected lower extremity muscle strength, and the relationship between muscle strength and fall frequency. The findings may contribute to a better understanding of fall risk and balance impairment i...Mostrar más
Descripción detallada
Myotonic dystrophy type 1 is a multisystem neuromuscular disorder characterized by myotonia, progressive muscle weakness, and functional limitations. Distal muscle weakness, impaired postural control, and gait dysfunction may increase the risk of falls and negatively affect daily activities and quality of life. Although falls and balance impairment are clinically important in patients with myotonic dystrophy type 1, ...Mostrar más
Título oficial
Determination of Fall Frequency and Factors Affecting Dynamic Balance in Patients With Myotonic Dystrophy Type 1: A Cross-Sectional Observational Single-Center Study
Condiciones médicas
Distrofia miotónica tipo 1CaídasPublicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:Otros ID del estudio
- 2025-217
Número del NCT
Inicio del estudio (real)
2025-06-20
Última actualización
2026-03-25
Fecha de finalización (estimada)
2026-06-15
Inscripción (prevista)
41
Tipo de estudio
Observacional
Estado general
Activo, no reclutando
Palabras clave
dynamic balance
falls
fall frequency
fear of falling
muscle strenght
neuromuscular disease
postural control
gait
balance impairment
rehabilitation
falls
fall frequency
fear of falling
muscle strenght
neuromuscular disease
postural control
gait
balance impairment
rehabilitation
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
Myotonic Dystrophy Type 1 Group Patients with myotonic dystrophy type 1 who are evaluated for fall frequency, dynamic balance, fear of falling, and lower extremity muscle strength. | N/A |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Fall frequency | Fall frequency will be assessed using semi-structured questions regarding the number of falls experienced by patients with myotonic dystrophy type 1. | At baseline |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Fear of falling | Fear of falling will be assessed using semi-structured questions regarding the fear of falling experienced by patients with myotonic dystrophy type 1. | At baseline |
Muscular Impairment Rating Scale score | Disease-related muscle involvement severity will be assessed using the Muscular Impairment Rating Scale (MIRS). | At baseline |
Dynamic balance performance by Timed Up and Go test | Dynamic balance performance will be assessed using the Timed Up and Go (TUG) test. | At baseline |
Walking performance by 10-Meter Walk Test at maximum safe speed | Walking performance and dynamic mobility will be assessed using the 10-Meter Walk Test at maximum safe speed. | At baseline |
Isometric muscle strength | Isometric muscle strength of selected muscle groups will be measured to evaluate the relationship between muscle strength and fall frequency. | At baseline |
Hand grip strength | Hand grip strength will be measured using a hand grip strength assessment. | At baseline |
Balance performance by Berg Balance Scale | Balance performance will be evaluated using the Berg Balance Scale. | At baseline |
Functional Ambulation Scale score | Ambulation level will be recorded using the Functional Ambulation Scale (FAS). | At baseline |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto
Edad mínima
18 Years
Criterios de sexo
Todos
- Adults aged between 18 and 60 years old
- Diagnosis of myotonic dystrophy type 1
- Ability to understand and follow study instructions
- Ability to ambulate, with or without an assistive device, sufficiently to perform the study assessments
- Willingness to participate and provide written informed consent
- Severe cognitive impairment interfering with understanding or completion of the study assessments
- Severe visual impairment interfering with balance and mobility testing
- Severe sensory impairment, including markedly impaired vibration sensation, that may affect balance assessment
- Any additional neurological, musculoskeletal, vestibular, or other medical condition that could substantially affect gait, balance, or fall risk independently of myotonic dystrophy type 1
- Acute medical condition or unstable clinical status at the time of assessment
- Inability to complete the study evaluations
Parte responsable del estudio
Ceren Arslan, Investigador principal, Resident Physician, Antalya Training and Research Hospital
No hay datos de contacto.
1 Centros del estudio en 1 países
Antalya
Antalya Training and Research Hospital, Antalya, Antalya, 07100, Turkey (Türkiye)