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

26. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

28

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Control
Conventional occupational therapy
Annen: 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.
Eksperimentell: Experimental
Combined virtual reality-based exercises and conventional occupational therapy
Annen: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Berg Balance Scale
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Functional Reaches Test
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hospitales Nisa

Samarbeidspartnere

Universitat Politècnica de València

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. februar 2023

Primær fullføring (Faktiske)

9. oktober 2025

Studiet fullført (Faktiske)

9. oktober 2025

Datoer for studieregistrering

Først innsendt

18. juni 2026

Først innsendt som oppfylte QC-kriteriene

26. juni 2026

Først lagt ut (Faktiske)

2. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

IPD available upon reasonable request

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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