- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06657989
Intensidad óptima del entrenamiento del equilibrio reactivo para adultos mayores sanos
Falls in daily life are a serious risk for older adults. A new type of balance training, called reactive balance training (RBT) involves people losing balance many times so that they can practice fast balance reactions, like stepping reactions. Differences in training program features might explain differences in the results of previous RBT studies. Training intensity is the difficulty or challenge of the training program. It would be valuable to know if high-intensity RBT improves balance reactions quickly. The main goal of this study is to see if more intense RBT improves balance reactions faster than less intense RBT. The investigators will compare how quickly people improve balance reactions between high- and moderate-intensity RBT, and between RBT and a control program that does not include RBT. The investigators will also test if the improvements in balance reactions last after the training program is over. The secondary goals are to understand exactly how balance reactions improve with training, and to determine if people who complete RBT improve their general balance skills, and falls efficacy more than people who do not complete RBT.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Avril Mansfield, PhD
- Número de teléfono: 7831 416-597-3422
- Correo electrónico: avril.mansfield@uhn.ca
Copia de seguridad de contactos de estudio
- Nombre: David Jagroop
- Número de teléfono: 7614 416-597-3422
- Correo electrónico: david.jagroop@uhn.ca
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5G 2A2
- Reclutamiento
- University Health Network
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Contacto:
- David Jagroop
- Número de teléfono: 7614 416-597-3422
- Correo electrónico: david.jagroop@uhn.ca
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Community-dwelling older adults (65-80 years old)
Exclusion Criteria:
- Unable to stand independently without upper-limb support for >30 seconds and/or walk independently (without a gait aid) for ≥10 metres;
- Diagnosed neurological condition that could affect balance control (e.g., stroke, Parkinson's disease);
- Score below normative values on the Montreal Cognitive Assessment;
- Score below age-matched normative values for sensory and motor function, as assessed using the FallScreen battery;
- Have insufficient English language comprehension such that they cannot understand instructions;
- Have contraindications to reactive balance training such as severe osteoporosis; and/or
- Are currently attending physiotherapy or supervised exercise.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: High intensity reactive balance training
Participants will complete 5 1-hour training sessions over 11 days. During each training session, participants will complete 36 multi-directional (left-, right-, and forward-fall) perturbations. Participants assigned to high-intensity RBT will experience perturbations at 150% of the multi-step threshold; for example, for a multi-step threshold of 2 m/s^2 the high intensity perturbation will be 3 m/s^2. |
Reactive balance training involves clients experiencing repeated balance perturbations so that they can practice and improve control of reactions to avoid falling after a loss of balance.
Otros nombres:
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Comparador activo: Moderate intensity reactive balance training
Participants will complete 5 1-hour training sessions over 11 days. During each training session, participants will complete 36 multi-directional (left-, right-, and forward-fall) perturbations. Participants assigned to moderate-intensity RBT will experience perturbations at 100% of the multi-step threshold; for example, for a multi-step threshold of 2 m/s^2 the high intensity perturbation will be 2 m/s^2. |
Reactive balance training involves clients experiencing repeated balance perturbations so that they can practice and improve control of reactions to avoid falling after a loss of balance.
Otros nombres:
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Comparador falso: Walking control group
Participants assigned to the walking control group will complete 36 trials of unperturbed walking in each training session. |
Overground walking |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of reactive steps
Periodo de tiempo: Two weeks
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Learning rate for number of steps to recover from 'backward fall' balance perturbations |
Two weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Step initiation time
Periodo de tiempo: One week and 12 weeks post-training
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Time from perturbation onset time to foot off time |
One week and 12 weeks post-training
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Step execution time
Periodo de tiempo: One week and 12 weeks post-training
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Time from foot off to foot contact of the first step |
One week and 12 weeks post-training
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Step length
Periodo de tiempo: One week and 12 weeks post-training
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Difference in foot position from foot off to foot contact |
One week and 12 weeks post-training
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Braking impulse
Periodo de tiempo: One week and 12 weeks post-training
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Antero-posterior shear force generated over time on step contact |
One week and 12 weeks post-training
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Mechanical margin of stability
Periodo de tiempo: One week and 12 weeks post-training
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Distance between the extrapolated centre of mass (incorporating centre of mass position and velocity) and the edge of the base of support |
One week and 12 weeks post-training
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Balance evaluation systems test
Periodo de tiempo: One week and 12 weeks post-training
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Scale ranges from 0-100, with higher scores indicating better outcome |
One week and 12 weeks post-training
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Falls efficacy scale - International
Periodo de tiempo: One week, 12 weeks, and 12 months post-training
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Scale range: 10-100; higher values indicate worse outcome |
One week, 12 weeks, and 12 months post-training
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidencia de caídas perjudiciales
Periodo de tiempo: 12 meses post-entrenamiento
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12 meses post-entrenamiento
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Número de participantes con miedo a caerse
Periodo de tiempo: Una semana, 12 semanas y 12 meses después del entrenamiento.
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Una semana, 12 semanas y 12 meses después del entrenamiento.
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Número de participantes con restricción de actividad por miedo a caerse
Periodo de tiempo: Una semana, 12 semanas y 12 meses después del entrenamiento.
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Una semana, 12 semanas y 12 meses después del entrenamiento.
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Fall incidence
Periodo de tiempo: 12 months post-training
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Falls in daily life |
12 months post-training
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5-level EuroQoL health status measure (EQ-5D-5L)
Periodo de tiempo: One week, 12 weeks, and 12 months post-training
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Scale range for descriptive component: 5-25, higher values indicate worse outcome; Scale range for visual analogue scale: 0-100, higher values indicate better outcome |
One week, 12 weeks, and 12 months post-training
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Avril Mansfield, PhD, University Health Network, Toronto
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 24-5665
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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