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| Name | Class |
|---|---|
| Centro de Referencia Estatal de Atención Al Daño Cerebral | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal Balance Rehabilitation Program | Behavioral | A multimodal rehabilitation program based on balance dimensions designed to improve balance performance in people with acquired brain injury. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta Fernández Hontoria, MSc | Contact | +34 917 355 190 | Marta.Fdez13@alu.uclm.es | |
| Cristina Lirio Romero, PhD | Contact | +34926051459 | Cristina.Lirio@uclm.es |
| Name | Affiliation | Role |
|---|---|---|
| Marta Fernández Hontoria, MSc | Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC), IMSERSO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC) | Madrid | Madrid | 28031 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41453610 | Background | 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. |
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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.
Data and supporting information will become available 12 months after publication of the primary study results and will remain available for 5 years.
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).
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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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.
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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.
| Conventional Physiotherapy | Other | Conventional physiotherapy routinely provided at CEADAC according to standard clinical practice. |
|
| 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 |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |