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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Marta Fernández Hontoria, MSc
- Номер телефона: +34 917 355 190
- Электронная почта: Marta.Fdez13@alu.uclm.es
Учебное резервное копирование контактов
- Имя: Cristina Lirio Romero, PhD
- Номер телефона: +34926051459
- Электронная почта: Cristina.Lirio@uclm.es
Места учебы
-
-
Madrid
-
Madrid, Madrid, Испания, 28031
- Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC)
-
Контакт:
- Marta Fernández Hontoria, MSc
- Номер телефона: +34914785000
- Электронная почта: Marta.Fdez13@alu.uclm.es
-
Главный следователь:
- Marta Fernández Hontoria, MSc
-
Младший исследователь:
- Cristina Lirio Romero, PhD
-
Младший исследователь:
- MªTeresa Agulló Ortuño, PhD
-
Младший исследователь:
- Susana Pajares García, Dra
-
Младший исследователь:
- Rocío Palomo Carrión, PhD
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
|
Активный компаратор: 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.
|
Conventional physiotherapy routinely provided at CEADAC according to standard clinical practice.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Balance performance assessed using the Spanish adaptation of the Balance Evaluation Systems Test validated in people with acquired brain injury (BESTest_DCA).
Временное ограничение: Baseline and 12 weeks (end of intervention)
|
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)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Mobility assessed with the Timed Up and Go test (TUG)
Временное ограничение: 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)
Временное ограничение: Baseline, 12 weeks, 6-week follow-up and 12-week follow-up
|
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
Временное ограничение: Baseline and 12 weeks
|
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.
|
Baseline and 12 weeks
|
|
Number of falls
Временное ограничение: During the 12-week intervention and 12-week follow-up period
|
Number of falls reported during the intervention and follow-up period.
|
During the 12-week intervention and 12-week follow-up period
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Marta Fernández Hontoria, MSc, Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC), IMSERSO
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- MFernandez01
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .