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Balance Dimensions-Based Rehabilitation Program in People With Acquired Brain Injury (BALANCE-DCA)

8 luglio 2026 aggiornato da: University of Castilla-La Mancha

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

68

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Spagna
    • Madrid
      • Madrid, Madrid, Spagna, 28031
        • Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC)
        • Contatto:
        • Investigatore principale:
          • Marta Fernández Hontoria, MSc
        • Sub-investigatore:
          • Cristina Lirio Romero, PhD
        • Sub-investigatore:
          • MªTeresa Agulló Ortuño, PhD
        • Sub-investigatore:
          • Susana Pajares García, Dra
        • Sub-investigatore:
          • Rocío Palomo Carrión, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: Multimodal Balance Rehabilitation Program
A multimodal rehabilitation program based on balance dimensions designed to improve balance performance in people with acquired brain injury.
Comparatore attivo: 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.
Altro: Conventional Physiotherapy
Conventional physiotherapy routinely provided at CEADAC according to standard clinical practice.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Balance performance assessed using the Spanish adaptation of the Balance Evaluation Systems Test validated in people with acquired brain injury (BESTest_DCA).
Lasso di tempo: 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.
Baseline and 12 weeks (end of intervention)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mobility assessed with the Timed Up and Go test (TUG)
Lasso di tempo: Baseline, 12 weeks, 6-week follow-up and 12-week follow-up
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)
Lasso di tempo: Baseline, 12 weeks, 6-week follow-up and 12-week follow-up
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
Lasso di tempo: Baseline and 12 weeks
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
Lasso di tempo: During the 12-week intervention and 12-week follow-up period
Number of falls reported during the intervention and follow-up period.
During the 12-week intervention and 12-week follow-up period

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Castilla-La Mancha

Collaboratori

Centro de Referencia Estatal de Atención Al Daño Cerebral

Investigatori

  • Investigatore principale: Marta Fernández Hontoria, MSc, Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC), IMSERSO

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 giugno 2028

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

17 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

10 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MFernandez01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

Data and supporting information will become available 12 months after publication of the primary study results and will remain available for 5 years.

Criteri di accesso alla condivisione IPD

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).

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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