Virtual Reality Software for Patients With Stroke

NCT06132399 | Recruiting DMC

• 1 other identifier: CPP2021-008497
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 4

Brief 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. 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

Conditions

Stroke

Keywords

stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  Changes from baseline to weeks 13 and 26

Secondary Outcomes (15)

• Quality of life (NEWSQOL)

  Changes from baseline to weeks 13 and 26

• Upper extremity motor function (Fugl-Meyer assessment of Upper Extremity)

  Changes from baseline to weeks 13 and 26

• Gross manual dexterity (The Box and Block Test)

  Changes from baseline to weeks 13 and 26

• Handgrip strength

  Changes from baseline to weeks 13 and 26

• Lower extremity function (Berg Balance Scale)

  Changes from baseline to weeks 13 and 26

Study Arms (3)

Commercial non-immersive virtual reality group (CVR)

ACTIVE COMPARATOR

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

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).

Device: META QUEST 3 virtual reality glasses

Usual care (UC)

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

META QUEST 3 virtual reality glasses DEVICE

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

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

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.

Commercial non-immersive virtual reality group (CVR)

Usual care 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.

Usual care (UC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Almeria: lead
• Ministerio de Ciencia e Innovación, Spain: collaborator
• European Union: collaborator

Study Sites (4)

University of Almería

Almería, Almería, 04120, Spain

RECRUITING

Torrecárdenas University Hospital

Almería, 04009, Spain

RECRUITING

San Cecilio University Hospital

Granada, 18016, Spain

RECRUITING

University of Granada

Granada, 18071, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 39161559 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Alberto Soriano-Maldonado, PhD

  Universidad de Almeria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Soriano-Maldonado, PhD

CONTACT

950 01 55 50; asoriano@ual.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 15, 2023
• Study Start: November 15, 2024
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Two years (24 months) after the study completion.
• Access Criteria: The PI must be contacted and a minimum number of co-authors from the research team must be included in any publication.

Locations

ES (4)