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Completed

NCT Number: NCT07682194

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRENEA. Instituto de Rehabilitación Neurológica

Valencia, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

conventional occupational therapy

Other

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.

Virtual reality-based exercises in ecologically valid environments

Other

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.

Primary outcomes

  1. Change in Berg Balance Scale

    Time frame: 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

Secondary outcomes

  1. Change in Functional Reaches Test

    Time frame: 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

  2. Change in Four Square Step Test

    Time frame: 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

  3. Change in the 10-meters walk Test

    Time frame: 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

  4. Change in the Activities-Specific Balance Confidence Scale

    Time frame: 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.

  5. Change in the Conner's Continuous Performance Test III

    Time frame: 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

  6. Changes in the Spatial Span Test

    Time frame: 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

  7. Changes in the Trail Making Test

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospitales Nisa

Other

Collaborators

  • Universitat Politècnica de València

Registry information

Official study title

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

Acronym: RECOVER

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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