StrokeRESETNCT06132399
Virtual Reality Software for Patients With Stroke
A study testing META QUEST 3 virtual reality glasses and Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan) in people with Stroke, run by Universidad de Almeria at 4 sites in Spain.
Trial summary
The goal os this clinical trial is to develop and validate a gamified, fully immersive, and stroke-specific virtual reality software to improve physical disability and quality of life in patients with stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- META QUEST 3 virtual reality glasses and Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 4 sitesSpain
- Study dates
- 15 Nov 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women and men with either an ischemic or hemorrhagic stroke
- Stroke between the last 7 to 14 days
- Functional independence before stroke (modified Rankin scale <3)
- Paresis of the lower extremity, upper extremity, or both, with a score ≤3 on the "motor arm" item of the National Institutes of Health Stroke Scale (NIHSS) scale
- Trunk control in seated and standing position
- Ability to understand basic instructions and to decide whether to sign informed consent
Who cannot join
- Moderate-severe aphasia that precludes understanding the required tasks
- Cognitive impairment that precludes cooperation with tasks
- Serious behavioral problems or mental disorders
- Lower extremity deep vein thrombosis, quadriplegia, neurodegenerative diseases, lower limb fractures, or recent myocardial infarction
- Vital organ (heart, lung, liver, kidney, etc.) failure, malignant tumor, or other unstable condition
- A history of cerebrovascular disease (if not fully resolved)
- Photosensitive epilepsy
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites, 4 recruiting
- Recruiting
University of Almería
Almería, Almería, 04120
Alberto Soriano Maldonado, PhD, asoriano@ual.es
- Recruiting
Torrecárdenas University Hospital
Almería, 04009
Patricia Martínez Sánchez, MD, patrindalo@hotmail.com
- Recruiting
San Cecilio University Hospital
Granada, 18016
Inmaculada Villegas Rodríguez, MD, adavillega@gmail.com
- Recruiting
University of Granada
Granada, 18071
Francisco J Amaro-Gahete, MD, PhD, amarof@ugr.es
About this study
Official title: Development and Validation of a Novel Virtual Reality Software for Improving Disability and Quality of Life in Patients With Stroke
The goal os this clinical trial is to develop and validate a gamified, fully immersive, and stroke-specific virtual reality software to improve physical disability and quality of life in patients with stroke.
The main questions it aims to answer are:
- To assess the effects of a gamified, fully immersive and stroke-specific virtual reality 10-week intervention combined with usual care rehabilitation, compared to usual care rehabilitation alone and in combination with a commercially available VR system, on disability in patients with stroke.
- To assess the effects of a gamified, fully immersive and stroke-specific virtual reality intervention combined with usual care rehabilitation, compared to usual care rehabilitation alone and in combination with a commercially available virtual reality system, on quality of life, upper-body motor function, gross manual dexterity, handgrip strength, static and dynamic balance, and cognitive function in patients with stroke
Read the detailed description
Stroke is the leading cause of long-term disability and ranks as the second most prevalent cause of mortality worldwide. According to data from the World Health Organization, since 2005, the global probability of a person experiencing a stroke has increased by 50 percent. It is expected that 1 in 4 individuals will face the risk of having a stroke in their lifetime. A stroke can result in significant loss of motor functions, communications abilities, weakness, or hemiparesis, leading to a diminished quality of life. Therefore, improving the rehabilitation process is evidently of paramount significance. Virtual reality has emerged as a novel strategy to improve neurological diseases; however, there is an absence of an immersive software designed specifically for stroke patients within a gamified environment. Therefore, the aim of RESET randomized controlled trial is to evaluate the effect of a gamified, fully immersive, and stroke-specific virtual reality software on disability in stroke patients.
- Conditions
- Stroke
- Being tested
- META QUEST 3 virtual reality glasses, Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan), Usual care
- Keywords
- stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
META QUEST 3 virtual reality glassesDevice
The RESET virtual reality software will be integrated into META QUEST 3 glasses (Meta Platforms, San Francisco, CA, US) by DYNAMICS.
Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan)Device
This group will use the Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan) gaming system with the Sports package games.
Usual careOther
The UC intervention consists of 3 sessions/week of 90' of physical therapy and occupational therapy conducted by a physiotherapist and an occupational therapist.
| Study group | Role | What they receive |
|---|---|---|
| Commercial non-immersive virtual reality group (CVR) | Active comparator | Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan). Receives: Device: Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan) |
| Gamified, fully immersive and stroke-specific virtual reality group (RESET) | Experimental | The RESET virtual reality software will be integrated in the META QUEST 3 glasses (Meta Platforms, San Francisco, CA, US). Receives: Device: META QUEST 3 virtual reality glasses |
| Usual care (UC) | Active comparator | 3 session/week of 90 minutes of physical therapy and occupational therapy. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability (The Barthel index)
An ordinal scale used to measure performance in activities of daily living. It consists of 10 common activities, with eight of them representing activities related to personal care and 2 related to mobility. These are assessed for independence/dependence and scored via an arbitrary weighting system- the index yields a total score out of 100 - the higher the score, the lower degree of disability.
Measured: Changes from baseline to weeks 13 and 26
Secondary outcomes (15)
Quality of life (NEWSQOL)
The Newcastle Stroke-Specific Quality of Life Measure assess the specific health-related quality of life measure of 56 items grouped into 11 domains: feelings; ADL/self-care; cognition; mobility; emotion; sleep; interpersonal relationships; communication; pain/sensation; vision; and fatigue. Each item is rated in range 0 to 3, and they are not significant individually. The results of each domain are obtained by the sum of the scores of the items, and higher values indicate greater impact on quality of life.
Measured: Changes from baseline to weeks 13 and 26
Upper extremity motor function (Fugl-Meyer assessment of Upper Extremity)
The test consists of 33 items that evaluate the movement, coordination and reflex action of the shoulder, elbow, forearm, wrist and hand. Each item is scored on a 3-point scale (0=cannot perform, 1=performs partially, 2=performs fully) and the total score ranges from a minimum of 0 (hemiplegia) to a maximum of 66 points.
Measured: Changes from baseline to weeks 13 and 26
Gross manual dexterity (The Box and Block Test)
The participant is seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition. A total of 150 colored, wooden cubes or blocks (2.5 cm) are placed in one compartment. The participant is instructed to move as many blocks as possible, one at a time, from one compartment to the other for 60 seconds. The score is the number of blocks moved from one compartment to the other during the trial time. The patient's hand must cross over the partition in order for a point to be given, and blocks that drop or bounce out of the second compartment onto the floor are still rewarded with a point. Multiple blocks carried over at the same time, count as a single point. Higher scores on the test indicate better gross manual dexterity.
Measured: Changes from baseline to weeks 13 and 26
Handgrip strength
Digital dynamometry will be used to assess the muscular strength in kilograms of both the affected and non-affected upper extremities.Participants will execute the test three times with each hand and the best score will be used to calculate the average of the three repetitions. The non-paretic side will be used as a reference for the paretic side.
Measured: Changes from baseline to weeks 13 and 26
Lower extremity function (Berg Balance Scale)
The Berg Balance Scale is a quantitative assessment of balance in older adults. The scale consists of 14 items requiring subjects to maintain positions or complete movement tasks (common to everyday life) of varying levels of difficulty. Items receive a score of 0-4 based on ability to meet the specific time and distance requirements of the test. 0 represents inability to complete the item and a 4 represents the ability to complete it independently.
Measured: Changes from baseline to weeks 13 and 26
Lower extremity function (Time Up and Go test)
The Time Up and Go assesses the ability to perform sequential motor tasks relative to walking and turning. The test requires participants to stand up from a chair, walk a distance of 3 meters, turn around, walk back to the chair and seat by themselves in the minimum timeframe possible. The time taken to complete the test is registered.
Measured: Changes from baseline to weeks 13 and 26
Cognitive function
The Montreal cognitive assessment, MoCA, consists of 10 simple questions or tasks related to cognitive function. Typically, these are grouped into the following cognitive domains: short term memory, visuospatial abilities, executive functions, attention, concentration, working memory, language, and orientation to time and place. The total score ranges 0-30. Higher scores indicating better cognitive performance.
Measured: Changes from baseline to weeks 13 and 26
Cognitive function
The Trail-Making Test will be used to assess the executive function. Successful performance of this test requires letter and number recognition, mental flexibility, visual scanning, and motor function. The Part A consists of 25 circles with the numbers 1-25 written randomly in the circles. The participant is required to connect the circles with a pencil as quickly as possible (i.e. number one to number two, etc). The Part B of the test consists of 25 circles, 13 of them numbered 1 to 13 and, and 12 lettered A to L, randomly distributed over a page of paper. The participant is required to connect the circles with a pencil as quickly as possible, alternating between numbers and letters and taking both series in ascending sequence (i.e. 1, A, 2, B, 3, C…). The time taken to complete the task and the number of errors are recorded in seconds. Greater time indicates greater impairment.
Measured: Changes from baseline to weeks 13 and 26
Plasma concentrations of inflammatory markers
Interleukin 2, 4, 6, 8, 10 (ng/mL)
Measured: Changes from baseline to weeks 13 and 26
BDNF quantification in blood
Change in Brain-derived neurotrophic factor (ng/mL)
Measured: Changes from baseline to weeks 13 and 26
GDNF quantification in blood
Change in Glial cell line-derived neurotrophic factor (ng/mL)
Measured: Changes from baseline to weeks 13 and 26
PACAP-38 quantification in blood
Change in Pituitary Adenylate Cyclase-Activating Polypeptide-38 (ng/mL)
Measured: Changes from baseline to weeks 13 and 26
Plasma concentrations of inflammatory markers, quantification in blood
Change in Tumor necrosis factor (TNF-alpha) (ng/mL)
Measured: Changes from baseline to weeks 13 and 26
IGF-1 quantification in blood
Change in Insulin-Like Growth Factor-1 (ng/mL)
Measured: Changes from baseline to weeks 13 and 26
NGF quantification in blood
Change in Nerve Growth Factor (ng/mL)
Measured: Changes from baseline to weeks 13 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start15 Nov 2024
- Primary completionAug 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain, European Union
- Responsible party
- Principal investigator, Alberto Soriano-Maldonado, Universidad de Almeria
- Investigators
- Alberto Soriano-Maldonado, PhD, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132399
- Sponsor's protocol ID
- CPP2021-008497
- Acronym
- RESET
- Status last verified
- Nov 2024
- First submitted
- 26 Oct 2023
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data will be shared once the study is finalised and the main results are published. IPD can be obtained by contacting the responsible party.
Publications
Hernandez-Martinez A, Fernandez-Escabias M, Amaya-Pascasio L, Carrilho-Candeias S, Ramos-Teodoro M, Gil-Rodriguez M, Orellana-Jaen A, Martinez-Rosales E, Ruiz-Gonzalez D, Esteban-Simon A, Castro-Ropero B, Del-Olmo-Iruela L, Lopez-Lopez MI, Ramos-Herrera AI, Fajardo-Rodriguez MF, Gomez-Garcia S, Rodriguez-Camacho M, Conde-Negri E, Rodriguez-Perez M, Marcos-Pardo PJ, Ruiz JR, Villegas-Rodriguez I, Amaro-Gahete FJ, Martinez-Sanchez P, Soriano-Maldonado A. Evaluation of the effects of a gamified, fully immersive and stroke-specific virtual reality intervention for improving disability and quality of life in patients with stroke in the subacute phase: study protocol of the RESET randomised trial. BMJ Open Sport Exerc Med. 2024 Aug 7;10(3):e002123. doi: 10.1136/bmjsem-2024-002123. eCollection 2024.
PubMed 39161559
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Novel Virtual Reality Software for Improving Disability and Quality of Life in Patients With Stroke
- ClinicalTrials.gov ID
- NCT06132399
- Acronym / sponsor ID
- RESET / CPP2021-008497
- Conditions
- Stroke
- Keywords
- stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain, European Union
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 15 Nov 2023 (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.
The goal os this clinical trial is to develop and validate a gamified, fully immersive, and stroke-specific virtual reality software to improve physical disability and quality of life in patients with stroke.
The main questions it aims to answer are:
- To assess the effects of a gamified, fully immersive and stroke-specific virtual reality 10-week intervention combined with usual care rehabilitation, compared to usual care rehabilitation alone and in combination with a commercially available VR system, on disability in patients with stroke.
- To assess the effects of a gamified, fully immersive and stroke-specific virtual reality intervention combined with usual care rehabilitation, compared to usual care rehabilitation alone and in combination with a commercially available virtual reality system, on quality of life, upper-body motor function, gross manual dexterity, handgrip strength, static and dynamic balance, and cognitive function in patients with stroke
Detailed description
Stroke is the leading cause of long-term disability and ranks as the second most prevalent cause of mortality worldwide. According to data from the World Health Organization, since 2005, the global probability of a person experiencing a stroke has increased by 50 percent. It is expected that 1 in 4 individuals will face the risk of having a stroke in their lifetime. A stroke can result in significant loss of motor functions, communications abilities, weakness, or hemiparesis, leading to a diminished quality of life. Therefore, improving the rehabilitation process is evidently of paramount significance. Virtual reality has emerged as a novel strategy to improve neurological diseases; however, there is an absence of an immersive software designed specifically for stroke patients within a gamified environment. Therefore, the aim of RESET randomized controlled trial is to evaluate the effect of a gamified, fully immersive, and stroke-specific virtual reality software on disability in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Commercial non-immersive virtual reality group (CVR) | Active comparator | Device: Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan)Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan). |
| Gamified, fully immersive and stroke-specific virtual reality group (RESET) | Experimental | Device: META QUEST 3 virtual reality glassesThe RESET virtual reality software will be integrated in the META QUEST 3 glasses (Meta Platforms, San Francisco, CA, US). |
| Usual care (UC) | Active comparator | Other: Usual care3 session/week of 90 minutes of physical therapy and occupational therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women and men with either an ischemic or hemorrhagic stroke
- Stroke between the last 7 to 14 days
- Functional independence before stroke (modified Rankin scale <3)
- Paresis of the lower extremity, upper extremity, or both, with a score ≤3 on the "motor arm" item of the National Institutes of Health Stroke Scale (NIHSS) scale
- Trunk control in seated and standing position
Key exclusion criteria (7 listed)
- Moderate-severe aphasia that precludes understanding the required tasks
- Cognitive impairment that precludes cooperation with tasks
- Serious behavioral problems or mental disorders
- Lower extremity deep vein thrombosis, quadriplegia, neurodegenerative diseases, lower limb fractures, or recent myocardial infarction
- Vital organ (heart, lung, liver, kidney, etc.) failure, malignant tumor, or other unstable condition
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 |
|---|---|---|
| META QUEST 3 virtual reality glassesThe RESET virtual reality software will be integrated into META QUEST 3 glasses (Meta Platforms, San Francisco, CA, US) by DYNAMICS. | Device | Gamified, fully immersive and stroke-specific virtual reality group (RESET) |
| Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan)This group will use the Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan) gaming system with the Sports package games. | Device | Commercial non-immersive virtual reality group (CVR) |
| Usual careThe UC intervention consists of 3 sessions/week of 90' of physical therapy and occupational therapy conducted by a physiotherapist and an occupational therapist. | Other | Usual care (UC) |
Primary outcome
Disability (The Barthel index)
Time frame: Changes from baseline to weeks 13 and 26
An ordinal scale used to measure performance in activities of daily living. It consists of 10 common activities, with eight of them representing activities related to personal care and 2 related to mobility. These are assessed for independence/dependence and scored via an arbitrary weighting system- the index yields a total score out of 100 - the higher the score, the lower degree of disability.
15 secondary outcomes
Quality of life (NEWSQOL)
Time frame: Changes from baseline to weeks 13 and 26
Upper extremity motor function (Fugl-Meyer assessment of Upper Extremity)
Time frame: Changes from baseline to weeks 13 and 26
Gross manual dexterity (The Box and Block Test)
Time frame: Changes from baseline to weeks 13 and 26
Handgrip strength
Time frame: Changes from baseline to weeks 13 and 26
Lower extremity function (Berg Balance Scale)
Time frame: Changes from baseline to weeks 13 and 26
Lower extremity function (Time Up and Go test)
Time frame: Changes from baseline to weeks 13 and 26
Cognitive function
Time frame: Changes from baseline to weeks 13 and 26
Cognitive function
Time frame: Changes from baseline to weeks 13 and 26
Plasma concentrations of inflammatory markers
Time frame: Changes from baseline to weeks 13 and 26
BDNF quantification in blood
Time frame: Changes from baseline to weeks 13 and 26
GDNF quantification in blood
Time frame: Changes from baseline to weeks 13 and 26
PACAP-38 quantification in blood
Time frame: Changes from baseline to weeks 13 and 26
Plasma concentrations of inflammatory markers, quantification in blood
Time frame: Changes from baseline to weeks 13 and 26
IGF-1 quantification in blood
Time frame: Changes from baseline to weeks 13 and 26
NGF quantification in blood
Time frame: Changes from baseline to weeks 13 and 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Derived from this study: PubMed 39161559Hernandez-Martinez A, Fernandez-Escabias M, Amaya-Pascasio L, Carrilho-Candeias S, Ramos-Teodoro M, Gil-Rodriguez M, Orellana-Jaen A, Martinez-Rosales E, Ruiz-Gonzalez D, Esteban-Simon A, Castro-Ropero B, Del-Olmo-Iruela L, Lopez-Lopez MI, Ramos-Herrera AI, Fajardo-Rodriguez MF, Gomez-Garcia S, Rodriguez-Camacho M, Conde-Negri E, Rodriguez-Perez M, Marcos-Pardo PJ, Ruiz JR, Villegas-Rodriguez I, Amaro-Gahete FJ, Martinez-Sanchez P, Soriano-Maldonado A. Evaluation of the effects of a gamified, fully immersive and stroke-specific virtual reality intervention for improving disability and quality of life in patients with stroke in the subacute phase: study protocol of the RESET randomised trial. BMJ Open Sport Exerc Med. 2024 Aug 7;10(3):e002123. doi: 10.1136/bmjsem-2024-002123. eCollection 2024.
- Individual participant dataSharing planned: Yes. All individual participant data will be shared once the study is finalised and the main results are published. IPD can be obtained by contacting the responsible party.
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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.
Alberto Soriano-Maldonado, PhD principal investigator
Universidad de Almeria
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing META QUEST 3 virtual reality glasses and Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan) in people with Stroke, run by Universidad de Almeria at 4 sites 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Soriano-Maldonado, PhD (950 01 55 50, asoriano@ual.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (The Barthel index) (time frame: Changes from baseline to weeks 13 and 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06132399, which also lists 1 linked publication.
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 27 Nov 2024.