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

NCT07696663 | Not Yet Recruiting

• 1 other identifier: MFernandez01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acquired Brain Injury; Balance Disorders

Keywords

Acquired Brain Injury; Balance Rehabilitation; Balance Training; Postural Control; Physiotherapy; Neurorehabilitation

Outcome Measures

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).

  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 Outcomes (4)

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

  Baseline, 12 weeks, 6-week follow-up and 12-week follow-up

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

  Baseline, 12 weeks, 6-week follow-up and 12-week follow-up

• Quality of life assessed with the CAVIDACE scale

  Baseline and 12 weeks

• Number of falls

  During the 12-week intervention and 12-week follow-up period

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Multimodal Balance Rehabilitation Program BEHAVIORAL

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

Experimental Group

Conventional Physiotherapy OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Centro de Referencia Estatal de Atención Al Daño Cerebral: collaborator

Study Sites (1)

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

Madrid, Madrid, 28031, Spain

Location

Related Publications (1)

• 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.

  PMID: 41453610 BACKGROUND

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Marta Fernández Hontoria, MSc

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Fernández Hontoria, MSc

CONTACT

+34 917 355 190; Marta.Fdez13@alu.uclm.es

Cristina Lirio Romero, PhD

CONTACT

+34926051459; Cristina.Lirio@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation. Due to the nature of the intervention, participants and physiotherapists delivering the treatments cannot be blinded. Outcome assessments will be performed by an independent evaluator who will not have access to treatment allocation information. Statistical analyses will be conducted using anonymized data coded by group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: an experimental group receiving a multimodal balance rehabilitation program based on balance dimensions and a control group receiving conventional physiotherapy. Participants will remain in their assigned group throughout the 12-week intervention period and follow-up assessments at 6 and 12 weeks.

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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).

Locations

ES (1)