Balance Dimensions-Based Rehabilitation Program in People With Acquired Brain Injury

Официальное название

Eficacia de un Programa de rehabilitación Basado en Las Dimensiones Del Equilibrio en Personas Con daño Cerebral Adquirido: Ensayo clínico Aleatorizado

Обзор

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.

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.

Вмешательства

• Поведенческое Multimodal Balance Rehabilitation Program
  A multimodal rehabilitation program based on balance dimensions designed to improve balance performance in people with acquired brain injury.
• Другое Conventional Physiotherapy
  Conventional physiotherapy routinely provided at CEADAC according to standard clinical practice.

Первичные конечные точки

• Balance performance assessed using the Spanish adaptation of the Balance Evaluation Systems Test validated in people with acquired brain injury (BESTest_DCA). [Срок оценки: Baseline and 12 weeks (end of intervention)]

Вторичные конечные точки (4)

• Mobility assessed with the Timed Up and Go test (TUG) [Срок оценки: Baseline, 12 weeks, 6-week follow-up and 12-week follow-up]
• Walking speed assessed with the 10-Meter Walk Test (10MWT) [Срок оценки: Baseline, 12 weeks, 6-week follow-up and 12-week follow-up]
• Quality of life assessed with the CAVIDACE scale [Срок оценки: Baseline and 12 weeks]
• Number of falls [Срок оценки: During the 12-week intervention and 12-week follow-up period]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC) — Madrid

Публикации

• Fernandez-Hontoria M, Romero-Galisteo RP, Torres-Lacomba M, Gonzalez-Alted C, Megia-Garcia-Carpintero A, Lirio-Romero C. Transcultural adaptation and validity to Spanish population with acquired brain injury of the Balance Evaluation Systems Test (BESTest) and their reduced versions (Mini-BESTest and Brief-BESTest). Neurologia (Engl Ed). 2026 Mar;41(2):501929. doi: 10.1016/j.nrleng.2025.501929. Ep PMID 41453610

Идентификаторы

NCT: NCT07696663 · MFernandez01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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