Acquired Brain InjuryBALANCE-DCANCT07696663
Balance Dimensions-Based Rehabilitation Program in People With Acquired Brain Injury
A study testing Multimodal Balance Rehabilitation Program and Conventional Physiotherapy in people with Acquired Brain Injury and Balance Disorders, run by University of Castilla-La Mancha at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acquired Brain Injury, Balance Disorders
- What is being tested?
- Multimodal Balance Rehabilitation Program and Conventional Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC)
Madrid, Madrid, 28031
Marta Fernández Hontoria, MSc, +34914785000, Marta.Fdez13@alu.uclm.es
Marta Fernández Hontoria, MSc
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Acquired Brain Injury, Balance Disorders
- Being tested
- Multimodal Balance Rehabilitation Program, Conventional Physiotherapy
- Keywords
- Acquired Brain Injury, Balance Rehabilitation, Balance Training, Postural Control, Physiotherapy, Neurorehabilitation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Balance Rehabilitation ProgramBehavioural
A multimodal rehabilitation program based on balance dimensions designed to improve balance performance in people with acquired brain injury.
Conventional PhysiotherapyOther
Conventional physiotherapy routinely provided at CEADAC according to standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks (end of intervention)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks
Number of falls
Number of falls reported during the intervention and follow-up period.
Measured: During the 12-week intervention and 12-week follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Referencia Estatal de Atención Al Daño Cerebral
- Responsible party
- Sponsor
- Investigators
- Marta Fernández Hontoria, MSc, Principal investigator, Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC), IMSERSO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696663
- Sponsor's protocol ID
- MFernandez01
- Acronym
- BALANCE-DCA
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 41453610
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eficacia de un Programa de rehabilitación Basado en Las Dimensiones Del Equilibrio en Personas Con daño Cerebral Adquirido: Ensayo clínico Aleatorizado
- ClinicalTrials.gov ID
- NCT07696663
- Acronym / sponsor ID
- BALANCE-DCA / MFernandez01
- Conditions
- Acquired Brain Injury, Balance Disorders
- Keywords
- Acquired Brain Injury, Balance Rehabilitation, Balance Training, Postural Control, Physiotherapy, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Centro de Referencia Estatal de Atención Al Daño Cerebral
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Multimodal Balance Rehabilitation ProgramParticipants 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. |
| Control Group | Active comparator | Other: Conventional PhysiotherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Balance Rehabilitation ProgramA multimodal rehabilitation program based on balance dimensions designed to improve balance performance in people with acquired brain injury. | Behavioural | Experimental Group |
| Conventional PhysiotherapyConventional physiotherapy routinely provided at CEADAC according to standard clinical practice. | Other | Control Group |
Primary outcome
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.
4 secondary outcomes
Mobility assessed with the Timed Up and Go test (TUG)
Time frame: Baseline, 12 weeks, 6-week follow-up and 12-week follow-up
Walking speed assessed with the 10-Meter Walk Test (10MWT)
Time frame: Baseline, 12 weeks, 6-week follow-up and 12-week follow-up
Quality of life assessed with the CAVIDACE scale
Time frame: Baseline and 12 weeks
Number of falls
Time frame: During the 12-week intervention and 12-week follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 41453610Fernandez-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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Fernández Hontoria, MSc principal investigator
Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC), IMSERSO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Balance Rehabilitation Program and Conventional Physiotherapy in people with Acquired Brain Injury and Balance Disorders, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Fernández Hontoria, MSc (+34 917 355 190, Marta.Fdez13@alu.uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07696663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.