An interventional study of Multimodal Balance Rehabilitation Program and Conventional Physiotherapy in Acquired Brain Injury and Balance Disorders, sponsored by University of Castilla-La Mancha. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by University of Castilla-La Mancha · Not applicable, Interventional, and Treatment
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:
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:
The information obtained from this study may help improve rehabilitation programs and daily functioning for people with acquired brain injury.
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.
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's planned enrollment of 68 is above the median of 41 across 612 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University of Castilla-La Mancha is the lead sponsor of 107 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
A multimodal rehabilitation program based on balance dimensions designed to improve balance performance in people with acquired brain injury.
Conventional physiotherapy routinely provided at CEADAC according to standard clinical practice.
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.
Time frame: Baseline and 12 weeks (end of intervention)
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 weeks
Number of falls
Number of falls reported during the intervention and follow-up period.
Time frame: During the 12-week intervention and 12-week follow-up period
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
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).
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Castilla-La Mancha →