- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07594405
Immediate Effects of Visual and Auditory Feedback Modalities on Dynamic Balance
Comparison of the Immediate Effects of Different Visual and/or Auditory Feedback Modalities on Dynamic Balance: A Randomized Controlled Trial
The goal of this randomized controlled trial is to compare the immediate effects of visual, auditory, and combined feedback modalities on dynamic balance in healthy young adults. It also aims to explore whether auditory stimulation (Mozart music) can influence postural control and whether combining visual and auditory feedback provides additional benefits.
The main questions it aims to answer are:
- Does visual feedback (mirror) improve dynamic balance performance measured by the SEBT?
- Does auditory feedback (Mozart music) improve dynamic balance performance?
- Does combined visual and auditory feedback lead to greater improvements compared to single modalities?
Researchers will compare three feedback conditions: visual feedback using a mirror, auditory feedback using Mozart music, and a combined visual-auditory condition.
Participants will:
- Be 60 healthy young adults aged 18-25 years
- Be randomly assigned to one of three groups (visual, auditory, combined)
- Perform the Star Excursion Balance Test (SEBT) in 8 directions
- Perform the test with and without feedback modalities
- Have their reach distances recorded and normalized according to their height
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Perla Mjaess, Dr
- Número de teléfono: +96178907792
- Correo electrónico: perla.mjaess1@usj.edu.lb
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Aged between 18 and 25 years
- Normal or corrected-to-normal vision (glasses or contact lenses allowed)
- No musculoskeletal disorders of the lower limbs
- No neurological disorders
- No history of prior surgery involving the spine or lower limbs
- No ear infections
- No vestibular, oculomotor, or balance disorders
Exclusion Criteria:
- Onset of dizziness or balance disturbances during the experiment
- Occurrence of a musculoskeletal injury during the experimental protocol preventing continuation of testing or sessions
- Use of medications affecting postural control during the study period
- Alcohol consumption within 12 hours prior to an assessment or training session
- Non-compliance with the protocol or repeated absence from scheduled sessions
Plan de estudios
¿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 |
|---|---|
|
Experimental: Visual Feedback (Mirror)
Participants perform the dynamic balance task using a mirror as a visual feedback tool.
The mirror provides real-time visual information about body alignment and movement during the Star Excursion Balance Test (SEBT).
|
Participants undergo three different sensory feedback conditions during the Star Excursion Balance Test (SEBT) to evaluate dynamic balance performance.
The interventions include: (1) visual feedback using a mirror to provide real-time information on body alignment and movement, (2) auditory feedback using Mozart music as an external acoustic stimulus during task execution, and (3) combined visual and auditory feedback integrating both modalities simultaneously.
Each condition is applied immediately during balance assessment in a randomized order, and reach distances in eight directions are recorded and normalized to participants' height.
|
|
Comparador activo: Auditory Feedback (Mozart Music)
Participants perform the dynamic balance task while being exposed to auditory feedback in the form of Mozart music.
The music is used as an external auditory stimulus during the execution of the Star Excursion Balance Test (SEBT) to assess its effect on postural control and balance performance.
|
Participants undergo three different sensory feedback conditions during the Star Excursion Balance Test (SEBT) to evaluate dynamic balance performance.
The interventions include: (1) visual feedback using a mirror to provide real-time information on body alignment and movement, (2) auditory feedback using Mozart music as an external acoustic stimulus during task execution, and (3) combined visual and auditory feedback integrating both modalities simultaneously.
Each condition is applied immediately during balance assessment in a randomized order, and reach distances in eight directions are recorded and normalized to participants' height.
|
|
Comparador activo: Combined Visual and Auditory Feedback
Participants perform the dynamic balance task while receiving both visual feedback through a mirror and auditory feedback through Mozart music.
The Star Excursion Balance Test (SEBT) is performed under simultaneous multimodal sensory stimulation to evaluate the combined effect on postural control and balance performance.
|
Participants undergo three different sensory feedback conditions during the Star Excursion Balance Test (SEBT) to evaluate dynamic balance performance.
The interventions include: (1) visual feedback using a mirror to provide real-time information on body alignment and movement, (2) auditory feedback using Mozart music as an external acoustic stimulus during task execution, and (3) combined visual and auditory feedback integrating both modalities simultaneously.
Each condition is applied immediately during balance assessment in a randomized order, and reach distances in eight directions are recorded and normalized to participants' height.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Dynamic balance performance measured by the Star Excursion Balance Test (SEBT)
Periodo de tiempo: Immediately after completion of each feedback condition during the single experimental session
|
Reach distance in 8 directions Normalized reach distance (% of leg length)
|
Immediately after completion of each feedback condition during the single experimental session
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- 2025-365
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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