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Balance Dimensions-Based Rehabilitation Program in People With Acquired Brain Injury (BALANCE-DCA)

2026年7月8日 更新者：University of Castilla-La Mancha

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

68

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 西班牙
    • Madrid
      • Madrid、Madrid、西班牙、28031
        • Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC)
        • 接触：
        • 首席研究员：
          • Marta Fernández Hontoria, MSc
        • 副研究员：
          • Cristina Lirio Romero, PhD
        • 副研究员：
          • MªTeresa Agulló Ortuño, PhD
        • 副研究员：
          • Susana Pajares García, Dra
        • 副研究员：
          • Rocío Palomo Carrión, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
行为的：Multimodal Balance Rehabilitation Program
A multimodal rehabilitation program based on balance dimensions designed to improve balance performance in people with acquired brain injury.
有源比较器：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.
其他：Conventional Physiotherapy
Conventional physiotherapy routinely provided at CEADAC according to standard clinical practice.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Balance performance assessed using the Spanish adaptation of the Balance Evaluation Systems Test validated in people with acquired brain injury (BESTest_DCA).
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
Mobility assessed with the Timed Up and Go test (TUG)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Castilla-La Mancha

合作者

Centro de Referencia Estatal de Atención Al Daño Cerebral

调查人员

  • 首席研究员：Marta Fernández Hontoria, MSc、Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC), IMSERSO

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年6月17日

首先提交符合 QC 标准的

2026年7月8日

首次发布 (实际的)

2026年7月10日

研究记录更新

最后更新发布 (实际的)

2026年7月10日

上次提交的符合 QC 标准的更新

2026年7月8日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MFernandez01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data underlying the results reported in publications will be shared. This includes demographic variables, baseline characteristics, intervention allocation, balance assessment scores (BESTest and secondary outcome measures), and follow-up data collected during the study. All direct identifiers will be removed before data sharing to protect participant confidentiality.

IPD 共享时间框架

Data and supporting information will become available 12 months after publication of the primary study results and will remain available for 5 years.

IPD 共享访问标准

De-identified data will be available upon reasonable request from qualified researchers for scientific purposes. Requests must include a research proposal and will be reviewed by the principal investigator. Access will be granted only after approval and in accordance with the study ethical approval, Spanish legislation, and the European General Data Protection Regulation (GDPR).

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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