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- Ensayo clínico NCT07709130
Rhythmic Auditory Stimulation and Dual-task Gait Training in Chronic Stroke
11 de julio de 2026 actualizado por: Seda Karaca, Recep Tayyip Erdogan University
Combined Rhythmic Auditory Stimulation and Dual-task Gait Training in Individuals With Chronic Stroke: a Pre-post Study With Exploratory Age-stratified Analyses
Rhythmic auditory stimulation and dual-task gait training may improve post-stroke mobility, but evidence regarding integrated programmes and age-related differences in treatment response remains limited.
The aim of the study is to evaluate changes in mobility, balance, motor dual-task performance, concern about falling, and health-related quality of life after a six-week combined programme, and to explore whether responses differed across age strata.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This prospective single-group pre-post study included individuals with chronic stroke.
Participants completed supervised rhythmic auditory stimulation and progressively intensified motor dual-task gait training three times weekly for six weeks.
Outcomes included motor dual-task performance, Timed Up and Go, bilateral single-leg stance, Mini-BESTest, Falls Efficacy Scale-International, and SF-36.
An independent assessor, unaware of previous scores and age-stratum allocation, conducted baseline and post-intervention assessments.
Prespecified exploratory analyses compared changes across age strata.
Tipo de estudio
Intervencionista
Inscripción (Actual)
46
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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-
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Rize, Turquía (Türkiye)
- Recep Tayyip Erdogan University
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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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- age ≥45 years
- stroke ≥6 months previously
- ability to walk at least 10 m independently or with minimal assistance
- sufficient hearing to follow rhythmic auditory cues
Exclusion Criteria:
- advanced aphasia
- severe neglect, cognitive impairment,
- marked visual impairment,
- severe spasticity (Modified Ashworth Scale score15 ≥3)
- severe cardiopulmonary disease
- vestibular dysfunction
- an orthopaedic condition limiting walking
- progressive neurological disease
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: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Stroke Group
Participants completed a supervised six-week programme comprising three 30-minute sessions per week (18 sessions; planned dose, 540 minutes).
During each session, they synchronized their steps with a metronome while performing tandem walking with progressively demanding object-carrying tasks.
Participants maintained their usual walking speed and were instructed to give equal attention to gait and the concurrent motor task.
Progression was designed by the research team in accordance with general motor-learning principles and involved predefined weekly increases in metronome tempo and concurrent motor-task complexity.
|
The intervention combined RAS with progressively intensified motor dual-task gait training.6
Participants completed a supervised six-week programme comprising three 30-minute sessions per week (18 sessions; planned dose, 540 minutes).
During each session, they synchronized their steps with a metronome while performing tandem walking with progressively demanding object-carrying tasks.
Participants maintained their usual walking speed and were instructed to give equal attention to gait and the concurrent motor task.
Progression was designed by the research team in accordance with general motor-learning principles and involved predefined weekly increases in metronome tempo and concurrent motor-task complexity.
provided that the preceding stage had been completed safely.
All sessions were delivered individually by the same licensed physiotherapist experienced in neurology.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Motor dual-task performance
Periodo de tiempo: at baseline and after the six-week programme
|
Participants completed a 10-m walk at their comfortable speed under single-task and motor dual-task conditions.
In the dual-task condition, they carried a ball while walking and were instructed to give equal attention to both tasks.
Three trials were performed under each condition, and mean completion time was used in the analysis.
Positive values indicated greater dual-task interference.
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at baseline and after the six-week programme
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Functional mobility
Periodo de tiempo: at baseline and after the six-week programme
|
Functional mobility was assessed using the Timed Up and Go test, with shorter completion times indicating better performance.
One familiarization trial preceded the timed assessment.
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at baseline and after the six-week programme
|
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Balance
Periodo de tiempo: at baseline and after the six-week programme
|
Dynamic balance was assessed using the 14-item Mini-BESTest, which evaluates anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait.
Total scores range from 0 to 28, with higher scores indicating better balance.
Static balance was assessed bilaterally using the Single-Leg Stance Test.
Two trials were performed on each side, and the longest duration before foot contact, stance-foot movement, or loss of balance was recorded.
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at baseline and after the six-week programme
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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)
15 de enero de 2026
Finalización primaria (Actual)
15 de mayo de 2026
Finalización del estudio (Actual)
15 de mayo de 2026
Fechas de registro del estudio
Enviado por primera vez
11 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de julio de 2026
Publicado por primera vez (Actual)
16 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026/01-1781
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
I do not prefer.
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. .