Balance Dimensions-Based Rehabilitation Program in People With Acquired Brain Injury (BALANCE-DCA)
Eficacia de un Programa de rehabilitación Basado en Las Dimensiones Del Equilibrio en Personas Con daño Cerebral Adquirido: Ensayo clínico Aleatorizado
The purpose of this clinical trial is to find out whether a rehabilitation program based on different dimensions of balance can improve balance, mobility, walking ability, and quality of life in people with acquired brain injury.
The main questions this study aims to answer are:
- Does this rehabilitation program improve balance?
- Does it improve mobility and walking ability?
- Does it reduce the risk of falls?
- Does it improve quality of life?
Researchers will compare a specific balance rehabilitation program with conventional physiotherapy to determine whether the balance program provides additional benefits.
Participants with acquired brain injury who meet the eligibility criteria will be randomly assigned to one of two groups. Both groups will receive treatment for 12 weeks.
Participants will:
- Complete balance and mobility assessments before starting treatment.
- Receive either the balance rehabilitation program or conventional physiotherapy five times per week.
- Complete assessments immediately after treatment and again 6 and 12 weeks later.
The information obtained from this study may help improve rehabilitation programs and daily functioning for people with acquired brain injury.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Acquired brain injury (ABI) is a major cause of disability in adults. It can affect balance, walking, mobility, independence in daily activities, and quality of life. Balance problems are common after ABI and may increase the risk of falls.
This study will evaluate a rehabilitation program based on different dimensions of balance in people with ABI. The program is designed to work on proprioception, biomechanical constraints, limits of stability, anticipatory postural adjustments, reactive postural responses, sensory orientation, and dynamic gait stability.
This is a prospective, longitudinal, randomized controlled trial with assessor blinding. The study will include 68 adults with ABI who are receiving active rehabilitation at the State Reference Centre for Brain Injury Care (CEADAC) in Madrid, Spain. Participants will be randomly assigned to one of two groups.
The experimental group will receive a structured multimodal balance rehabilitation program. The control group will receive conventional physiotherapy according to the usual clinical protocols at CEADAC. Both groups will receive treatment for 12 weeks, with five 60-minute sessions per week.
The main outcome will be balance performance, assessed with the Balance Evaluation Systems Test adapted for Acquired Brain Injury (BESTest_DCA). Secondary outcomes will include mobility, walking speed, fall risk, and quality of life, assessed with the Timed Up and Go Test, the 10-Meter Walk Test, and the CAVIDACE questionnaire (Spanish Quality of Life Questionnaire for People with Acquired Brain Injury).
Assessments will be performed at baseline, after 6 weeks of treatment, after 12 weeks of treatment, and at 6 and 12 weeks after the end of the intervention. Data will be analyzed to compare changes between the experimental and control groups over time.
This study may help determine whether a balance-specific rehabilitation program provides additional benefits compared with conventional physiotherapy in people with acquired brain injury.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Marta Fernández Hontoria, MSc
- Número de teléfono: +34 917 355 190
- Correo electrónico: Marta.Fdez13@alu.uclm.es
Copia de seguridad de contactos de estudio
- Nombre: Cristina Lirio Romero, PhD
- Número de teléfono: +34926051459
- Correo electrónico: Cristina.Lirio@uclm.es
Ubicaciones de estudio
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Madrid
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Madrid, Madrid, España, 28031
- Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC)
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Contacto:
- Marta Fernández Hontoria, MSc
- Número de teléfono: +34914785000
- Correo electrónico: Marta.Fdez13@alu.uclm.es
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Investigador principal:
- Marta Fernández Hontoria, MSc
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Sub-Investigador:
- Cristina Lirio Romero, PhD
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Sub-Investigador:
- MªTeresa Agulló Ortuño, PhD
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Sub-Investigador:
- Susana Pajares García, Dra
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Sub-Investigador:
- Rocío Palomo Carrión, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged 18 to 65 years.
- Diagnosis of acquired brain injury (stroke, traumatic brain injury, anoxic brain injury, brain tumor, or encephalitis).
- At least 2 months since the brain injury.
- Mini-Mental State Examination (MMSE) score greater than 24.
- Modified Rankin Scale (mRS) score of 3 or lower.
- Ability to walk independently or with an assistive device.
- Clinical stability and ability to participate in a rehabilitation program.
- Written informed consent signed by the participant.
Exclusion Criteria:
- Severe cognitive impairment (MMSE score of 24 or lower).
- Severe functional dependence (mRS score greater than 3).
- Unstable medical conditions that may interfere with participation.
- Severe musculoskeletal, cardiovascular, or other conditions that prevent safe participation in the intervention.
- Severe communication disorders that prevent understanding of study procedures.
- Participation in another clinical trial that may interfere with the study results.
Plan de estudios
¿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: Experimental Group
Participants will receive a multimodal balance rehabilitation program based on the dimensions of balance.
The intervention will be delivered 5 days per week, 60 minutes per session, for 12 weeks, and will include exercises targeting anticipatory postural adjustments, reactive postural control, sensory orientation, stability in gait and dynamic balance activities.
|
A multimodal rehabilitation program based on balance dimensions designed to improve balance performance in people with acquired brain injury.
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Comparador activo: Control Group
Participants will receive conventional physiotherapy routinely provided at CEADAC.
Treatment will be delivered 5 days per week, 60 minutes per session, for 12 weeks, following standard rehabilitation procedures.
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Conventional physiotherapy routinely provided at CEADAC according to standard clinical practice.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Balance performance assessed using the Spanish adaptation of the Balance Evaluation Systems Test validated in people with acquired brain injury (BESTest_DCA).
Periodo de tiempo: Baseline and 12 weeks (end of intervention)
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Change in balance performance measured using the Spanish adaptation of the Balance Evaluation Systems Test (BESTest_DCA), previously validated in people with acquired brain injury.
The test evaluates six balance control systems and provides a total score ranging from 0 to 108 points.
Higher scores indicate better balance performance.
|
Baseline and 12 weeks (end of intervention)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mobility assessed with the Timed Up and Go test (TUG)
Periodo de tiempo: Baseline, 12 weeks, 6-week follow-up and 12-week follow-up
|
Change in functional mobility measured using the Timed Up and Go (TUG) test.
The test records the time required to stand up from a chair, walk 3 meters, turn, walk back, and sit down.
Scores are measured in seconds.
Lower scores indicate better functional mobility.
|
Baseline, 12 weeks, 6-week follow-up and 12-week follow-up
|
|
Walking speed assessed with the 10-Meter Walk Test (10MWT)
Periodo de tiempo: Baseline, 12 weeks, 6-week follow-up and 12-week follow-up
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Change in walking speed measured using the 10-Meter Walk Test (10MWT).
Walking speed is calculated in meters per second (m/s).
Higher walking speed indicates better walking performance.
|
Baseline, 12 weeks, 6-week follow-up and 12-week follow-up
|
|
Quality of life assessed with the CAVIDACE scale
Periodo de tiempo: Baseline and 12 weeks
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Change in quality of life measured using the CAVIDACE Scale (proxy version).
The scale consists of 64 items scored from 0 to 3, with a total score ranging from 0 to 192 points.
Higher scores indicate better perceived quality of life.
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Baseline and 12 weeks
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Number of falls
Periodo de tiempo: During the 12-week intervention and 12-week follow-up period
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Number of falls reported during the intervention and follow-up period.
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During the 12-week intervention and 12-week follow-up period
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marta Fernández Hontoria, MSc, Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC), IMSERSO
Publicaciones y 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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MFernandez01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
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