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

26 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

28

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Control
Conventional occupational therapy
Autre: 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.
Expérimental: Experimental
Combined virtual reality-based exercises and conventional occupational therapy
Autre: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Berg Balance Scale
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Functional Reaches Test
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospitales Nisa

Collaborateurs

Universitat Politècnica de València

Les enquêteurs

  • Chercheur principal: Roberto Llorens, PhD, Universitat Politecnica de Valencia

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 février 2023

Achèvement primaire (Réel)

9 octobre 2025

Achèvement de l'étude (Réel)

9 octobre 2025

Dates d'inscription aux études

Première soumission

18 juin 2026

Première soumission répondant aux critères de contrôle qualité

26 juin 2026

Première publication (Réel)

2 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

IPD available upon reasonable request

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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