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Virtual Reality Software for Patients With Stroke

NCT ID: NCT06132399

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2025-11-30

Brief Summary

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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

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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

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Commercial non-immersive virtual reality group (CVR)

Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan).

Group Type ACTIVE_COMPARATOR

Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan)

Intervention Type DEVICE

This group will use the Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan) gaming system with the Sports package games.

Gamified, fully immersive and stroke-specific virtual reality group (RESET)

The RESET virtual reality software will be integrated in the META QUEST 3 glasses (Meta Platforms, San Francisco, CA, US).

Group Type EXPERIMENTAL

META QUEST 3 virtual reality glasses

Intervention Type DEVICE

The RESET virtual reality software will be integrated into META QUEST 3 glasses (Meta Platforms, San Francisco, CA, US) by DYNAMICS.

Usual care (UC)

3 session/week of 90 minutes of physical therapy and occupational therapy.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

The UC intervention consists of 3 sessions/week of 90' of physical therapy and occupational therapy conducted by a physiotherapist and an occupational therapist.

Interventions

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META QUEST 3 virtual reality glasses

The RESET virtual reality software will be integrated into META QUEST 3 glasses (Meta Platforms, San Francisco, CA, US) by DYNAMICS.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Usual care

The UC intervention consists of 3 sessions/week of 90' of physical therapy and occupational therapy conducted by a physiotherapist and an occupational therapist.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministerio de Ciencia e Innovación, Spain

OTHER_GOV

Sponsor Role collaborator

European Union

OTHER

Sponsor Role collaborator

Universidad de Almeria

OTHER

Sponsor Role lead

Responsible Party

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Alberto Soriano-Maldonado

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alberto Soriano-Maldonado, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Almeria

Locations

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University of Almería

Almería, Almería, Spain

Site Status RECRUITING

Torrecárdenas University Hospital

Almería, , Spain

Site Status RECRUITING

San Cecilio University Hospital

Granada, , Spain

Site Status RECRUITING

University of Granada

Granada, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Alberto Soriano-Maldonado, PhD

Role: CONTACT

[email protected]
950 01 55 50

Facility Contacts

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Alberto Soriano Maldonado, PhD

Role: primary

[email protected]

Patricia Martínez Sánchez, MD

Role: primary

[email protected]

Inmaculada Villegas Rodríguez, MD

Role: primary

[email protected]

Francisco J Amaro-Gahete, MD, PhD

Role: primary

[email protected]

References

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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.

Reference Type DERIVED
PMID: 39161559 (View on PubMed)

Other Identifiers

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CPP2021-008497

Identifier Type: -

Identifier Source: org_study_id