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Effects of Ecologically Valid VR Task-Oriented Exercises on Post-Stroke Motor and Cognitive Function (RECOVER)

26. Juni 2026 aktualisiert von: Hospitales Nisa

Effectiveness of Virtual Reality-based Task-oriented Exercises in Ecologically Valid Environments on Motor and Cognitive Function in Individuals Post-stroke. A Randomized Controlled Trial

Why is this study being done?

After a stroke, many people have problems with movement, such as walking, balance, and using their arms and hands. They may also experience difficulties with thinking skills, including attention, memory, and problem-solving. These movement and thinking abilities work closely together during everyday activities, such as preparing a meal, shopping, or moving safely through the home.

Traditional rehabilitation often treats movement and thinking problems separately. However, difficulties with attention, planning, and decision-making can affect a person's ability to move safely and learn new motor skills. Because of this, rehabilitation approaches that train both movement and thinking skills at the same time may provide greater benefits.

Virtual reality (VR) technology can create realistic, interactive environments that allow people to practice everyday activities in a safe setting. However, there is limited research on VR programs that simultaneously challenge both movement and thinking skills, and little is known about whether any benefits last over time.

What is the purpose of this study?

The purpose of this study is to compare a virtual reality-based rehabilitation program that combines movement and cognitive training in realistic everyday environments with conventional occupational therapy. The study will evaluate whether the VR program leads to greater improvements in motor function and cognitive function after stroke and whether these improvements are maintained over the long term.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Stroke causes long-term disability through interconnected motor deficits (affecting balance, gait, and upper limbs) and cognitive impairments (disrupting attention, memory, and executive functions). Although these domains are traditionally treated through separate physical and neuropsychological rehabilitation pathways, post-stroke motor performance heavily depends on the cognitive processes required to plan movements and allocate attentional resources. Consequently, patients often experience cognitive-motor interference during daily activities, and cognitive deficits can actively hinder motor learning and recovery. Despite this crucial interaction, virtual reality (VR) interventions that simultaneously target both motor and cognitive demands within ecologically valid environments remain scarce, and literature regarding the long-term maintenance of their benefits is limited. Based on this gap, the study hypothesizes that an ecologically valid, dual-demand VR intervention will outperform conventional occupational therapy in improving both motor and cognitive outcomes, aiming to evaluate and compare their immediate effects and long-term therapeutic gains.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

28

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienorte

  • Spanien
      • Valencia, Spanien
        • IRENEA. Instituto de Rehabilitación Neurológica

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:

  • Diagnosis of stroke confirmed by computed tomography or magnetic resonance imaging
  • Chronicity > six months
  • Ausence of severe cognitive deficits (Mini-Mental State Examination > 23)
  • Ability to stand safely and without assistance
  • No or minimal muscle tone (Modified Ashworth Scale < 3).

Exclusion Criteria:

  • Severe visual or hearing deficits
  • Unilateral spatial neglect
  • Ataxia
  • Orthopedic abnormalities
  • Lower limb pain syndrome or peripheral nerve injury affecting the lower limbs.

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: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Control
Conventional occupational therapy
Sonstiges: Conventional occupational therapy
Each session consists of three components. The first component includes preparatory activities designed to improve function of the affected upper limb. The second component focuses on fine motor skill training through exercises targeting reaching, grasping, object manipulation, and movements across the body's midline. The third component addresses individual motor and cognitive impairments through the practice of Basic Activities of Daily Living and Instrumental Activities of Daily Living, as well as structured problem-solving tasks related to everyday situations.
Experimental: Experimental
Combined virtual reality-based exercises and conventional occupational therapy
Sonstiges: Conventional occupational therapy
Each session consists of three components. The first component includes preparatory activities designed to improve function of the affected upper limb. The second component focuses on fine motor skill training through exercises targeting reaching, grasping, object manipulation, and movements across the body's midline. The third component addresses individual motor and cognitive impairments through the practice of Basic Activities of Daily Living and Instrumental Activities of Daily Living, as well as structured problem-solving tasks related to everyday situations.
Sonstiges: Virtual reality-based exercises in ecologically valid environments

The intervention consists of interactive video games to train activities of daily living in a customizable digital version of the participant's own kitchen.

During training, participants control a sex-matched avatar that reflects their real-time movements. They interact with common kitchen objects while practicing tasks that target both motor abilities, such as balance, posture, and hand-eye coordination, and cognitive abilities, such as attention, memory, planning, and problem-solving.

The system can use photographs of the participant's home kitchen to create a familiar and realistic virtual environment. This approach is intended to support the transfer of skills practiced during therapy to the participant's everyday activities at home.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Berg Balance Scale
Zeitfenster: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention

Change in the balance of the Berg Balance Scale from baseline to the end of the intervention and from the end of the intervention to follow-up.

The Berg Balance Scale is a clinical tool that assesses a person's static and dynamic balance to determine their risk of falling. It is primarily used for older adults and patients with neurological or motor disorders. Score range 0-54
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Functional Reaches Test
Zeitfenster: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention

Change in the Functional Reaches Test from baseline to the end of the intervention and from the end of the intervention to follow-up.

The Functional Reach Test measures a person's dynamic balance and stability limits while standing. It specifically assesses the maximum distance a patient can reach forward with an outstretched arm without taking a step or losing balance. Score range: NA
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
Change in Four Square Step Test
Zeitfenster: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
Change in the seconds of the Four Square Step Test from baseline to the end of the intervention and from the end of the intervention to follow-up. The Four Square Step Test (FSST) is a performance-based assessment that evaluates dynamic balance, mobility, and the ability to change direction while walking. During the test, participants step as quickly as possible in a specific sequence through four squares formed by low obstacles on the floor, moving forward, backward, and sideways. The test measures the time required to complete the sequence and assesses balance control, coordination, agility, and the ability to safely negotiate obstacles during movement. It is commonly used to identify mobility limitations and fall risk in individuals with neurological conditions, including stroke. Score range: NA
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
Change in the 10-meters walk Test
Zeitfenster: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
Change in the 10-meters walk Test from baseline to the end of the intervention and from the end of the intervention to follow-up. The 10-Meter Walk Test measures walking speed in meters per second (m/s). It assesses functional mobility, independence, and frailty by recording the time it takes a patient to walk a short distance (typically the central 6- or 8-meter section of a 10- to 14-meter corridor). Score range: NA
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
Change in the Activities-Specific Balance Confidence Scale
Zeitfenster: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
Change in the Activities-Specific Balance Confidence Scale from baseline to the end of the intervention and from the end of the intervention to follow-up. The Activities-Specific Balance Confidence Scale is a questionnaire that assesses a person's confidence in maintaining balance and avoiding falls while performing 16 everyday activities. Score range: 0-100.
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
Change in the Conner's Continuous Performance Test III
Zeitfenster: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
Change in the Conner's Continuous Performance Test III from baseline to the end of the intervention and from the end of the intervention to follow-up. The Conners Continuous Performance Test is a computerized neuropsychological test that assesses sustained attention, vigilance, inhibitory control (impulsivity), and selective attention. Score range: NA
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
Changes in the Spatial Span Test
Zeitfenster: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
Changes in the Spatial Span Test from baseline to the end of the intervention and from the end of the intervention to follow-up. The Spatial Span Test measures visuospatial short-term memory and visual working memory capacity. Score ranges: 0-9
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
Changes in the Trail Making Test
Zeitfenster: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
Changes in the seconds of part A and part B for Trail Making Test from baseline to the end of the intervention and from the end of the intervention to follow-up. The Trail Making Test is designed to assess attention, processing speed, cognitive flexibility, and executive functions. It consists of two parts (A and B) in which the patient must connect numbered or lettered circles as quickly as posible. Score Range: 0-300 s
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention

Mitarbeiter und Ermittler

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

Sponsor

Hospitales Nisa

Mitarbeiter

Universitat Politècnica de València

Ermittler

  • Hauptermittler: Roberto Llorens, PhD, Universitat Politecnica de Valencia

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.

Nützliche Links

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 (Tatsächlich)

16. Februar 2023

Primärer Abschluss (Tatsächlich)

9. Oktober 2025

Studienabschluss (Tatsächlich)

9. Oktober 2025

Studienanmeldedaten

Zuerst eingereicht

18. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Juni 2026

Zuerst gepostet (Tatsächlich)

2. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • P0524032022
  • PID2022-141498OA-I00 (Andere Zuschuss-/Finanzierungsnummer: Ministerio de Ciencia e Innovación)
  • RTC2019-006933-7 (Andere Zuschuss-/Finanzierungsnummer: Ministerio de Ciencia e Innovación)
  • INREIA/2024/73 (Andere Zuschuss-/Finanzierungsnummer: Conselleria d'Innovació, Indústria, Comerç i Turisme)
  • CIDEXG/2022/15 (Andere Zuschuss-/Finanzierungsnummer: Conselleria d'Innovació, Universitats, Ciència i Societat Digital of Generalitat Valenciana)
  • 60/2023 (Andere Zuschuss-/Finanzierungsnummer: Fundació la Marató de la TV3)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

IPD available upon reasonable request

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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