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NCT Number: NCT07696663

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

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.

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Key information

Conditions

Acquired Brain Injury Balance Disorders Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC)

Madrid, 28031, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal Balance Rehabilitation Program

Behavioral

A multimodal rehabilitation program based on balance dimensions designed to improve balance performance in people with acquired brain injury.

Conventional Physiotherapy

Other

Conventional physiotherapy routinely provided at CEADAC according to standard clinical practice.

Primary outcomes

  1. Balance performance assessed using the Spanish adaptation of the Balance Evaluation Systems Test validated in people with acquired brain injury (BESTest_DCA).

    Time frame: 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.

Secondary outcomes

  1. Mobility assessed with the Timed Up and Go test (TUG)

    Time frame: 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.

  2. Walking speed assessed with the 10-Meter Walk Test (10MWT)

    Time frame: 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.

  3. Quality of life assessed with the CAVIDACE scale

    Time frame: 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.

  4. Number of falls

    Time frame: During the 12-week intervention and 12-week follow-up period

    Number of falls reported during the intervention and follow-up period.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Collaborators

  • Centro de Referencia Estatal de Atención Al Daño Cerebral

Registry information

Official study title

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

Acronym: BALANCE-DCA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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