StrokeRECOVERNCT07682194
Effects of Ecologically Valid VR Task-Oriented Exercises on Post-Stroke Motor and Cognitive Function
A study testing Conventional occupational therapy and Virtual reality-based exercises in ecologically valid environments in people with Stroke, run by Hospitales Nisa at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Conventional occupational therapy and Virtual reality-based exercises in ecologically valid environments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 16 Feb 2023to 9 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Severe visual or hearing deficits
- Unilateral spatial neglect
- Ataxia
- Orthopedic abnormalities
- Lower limb pain syndrome or peripheral nerve injury affecting the lower limbs.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Stroke
- Being tested
- Conventional occupational therapy, Virtual reality-based exercises in ecologically valid environments
- Keywords
- virtual reality, ecollogical validity, dual-task, balance, cognition, stroke, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional occupational therapyOther
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 environmentsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Conventional occupational therapy Receives: Other: Conventional occupational therapy |
| Experimental | Experimental | Combined virtual reality-based exercises and conventional occupational therapy Receives: Other: Conventional occupational therapy; Other: Virtual reality-based exercises in ecologically valid environments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Berg Balance Scale
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
Measured: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
Secondary outcomes (7)
Change in Functional Reaches Test
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
Measured: 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
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
Measured: 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
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
Measured: 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
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.
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start16 Feb 2023
- Primary completion9 Oct 2025
- Study completion9 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitales Nisa
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Politècnica de València
- Responsible party
- Sponsor
- Investigators
- Roberto Llorens, PhD, Principal investigator, Universitat Politecnica de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682194
- Sponsor's protocol ID
- P0524032022
- Other IDs
- PID2022-141498OA-I00, RTC2019-006933-7, INREIA/2024/73, CIDEXG/2022/15, 60/2023
- Acronym
- RECOVER
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07682194
- Acronym / sponsor ID
- RECOVER / P0524032022
- Conditions
- Stroke
- Keywords
- virtual reality, ecollogical validity, dual-task, balance, cognition, stroke, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospitales NisaUniversity, hospital or other
- Collaborators
- Universitat Politècnica de València
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 9 Oct 2025 (actual)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Conventional occupational therapyConventional occupational therapy |
| Experimental | Experimental | Other: Conventional occupational therapy, Other: Virtual reality-based exercises in ecologically valid environmentsCombined virtual reality-based exercises and conventional occupational therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- Severe visual or hearing deficits
- Unilateral spatial neglect
- Ataxia
- Orthopedic abnormalities
- Lower limb pain syndrome or peripheral nerve injury affecting the lower limbs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional occupational therapyEach 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. | Other | Control, Experimental |
| Virtual reality-based exercises in ecologically valid environmentsThe 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. | Other | Experimental |
Primary outcome
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
7 secondary outcomes
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 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 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 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 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
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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Llorens, PhD principal investigator
Universitat Politecnica de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional occupational therapy and Virtual reality-based exercises in ecologically valid environments in people with Stroke, run by Hospitales Nisa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.