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

8. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

68

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Spanien
    • Madrid
      • Madrid, Madrid, Spanien, 28031
        • Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC)
        • Kontakt:
        • Hauptermittler:
          • Marta Fernández Hontoria, MSc
        • Unterermittler:
          • Cristina Lirio Romero, PhD
        • Unterermittler:
          • MªTeresa Agulló Ortuño, PhD
        • Unterermittler:
          • Susana Pajares García, Dra
        • Unterermittler:
          • Rocío Palomo Carrión, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: Multimodal Balance Rehabilitation Program
A multimodal rehabilitation program based on balance dimensions designed to improve balance performance in people with acquired brain injury.
Aktiver Komparator: 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.
Sonstiges: Conventional Physiotherapy
Conventional physiotherapy routinely provided at CEADAC according to standard clinical practice.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Balance performance assessed using the Spanish adaptation of the Balance Evaluation Systems Test validated in people with acquired brain injury (BESTest_DCA).
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mobility assessed with the Timed Up and Go test (TUG)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Castilla-La Mancha

Mitarbeiter

Centro de Referencia Estatal de Atención Al Daño Cerebral

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. Juni 2028

Studienabschluss (Geschätzt)

1. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

17. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juli 2026

Zuerst gepostet (Tatsächlich)

10. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juli 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MFernandez01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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).

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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