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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acquired Brain Injury; Balance Disorders
• Intervention / Treatment: Behavioral: Multimodal Balance Rehabilitation Program; Other: Conventional Physiotherapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marta Fernández Hontoria, MSc; Phone Number: +34 917 355 190; Email: Marta.Fdez13@alu.uclm.es
• Study Contact Backup: Name: Cristina Lirio Romero, PhD; Phone Number: +34926051459; Email: Cristina.Lirio@uclm.es

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28031
      • Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC)
      • Contact: Marta Fernández Hontoria, MSc; Phone Number: +34914785000; Email: Marta.Fdez13@alu.uclm.es
      • Principal Investigator: Marta Fernández Hontoria, MSc
      • Sub-Investigator: Cristina Lirio Romero, PhD
      • Sub-Investigator: MªTeresa Agulló Ortuño, PhD
      • Sub-Investigator: Susana Pajares García, Dra
      • Sub-Investigator: Rocío Palomo Carrión, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Multimodal Balance Rehabilitation Program; A multimodal rehabilitation program based on balance dimensions designed to improve balance performance in people with acquired brain injury.
Active Comparator: 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.	Other: Conventional Physiotherapy; Conventional physiotherapy routinely provided at CEADAC according to standard clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance performance assessed using the Spanish adaptation of the Balance Evaluation Systems Test validated in people with acquired brain injury (BESTest_DCA).	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobility assessed with the Timed Up and Go test (TUG)	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)	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	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	Number of falls reported during the intervention and follow-up period.	During the 12-week intervention and 12-week follow-up period

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Collaborators: Centro de Referencia Estatal de Atención Al Daño Cerebral
• Investigators: Principal Investigator: Marta Fernández Hontoria, MSc, Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC), IMSERSO

Publications and helpful links

General Publications

• 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. Epub 2025 Dec 24.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Physiotherapy; Neurorehabilitation; Balance Training; Acquired Brain Injury; Postural Control; Balance Rehabilitation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: MFernandez01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: Data and supporting information will become available 12 months after publication of the primary study results and will remain available for 5 years.
• IPD Sharing Access Criteria: 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 Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No