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J Cent Nerv Syst Dis. 2020 Jan 21;12:1179573519899471. doi: 10.1177/1179573519899471. eCollection 2020.

The Impact of Rehabilitation-oriented Virtual Reality Device in Patients With Ischemic Stroke in the Early Subacute Recovery Phase: Study Protocol for a Phase III, Single-Blinded, Randomized, Controlled Clinical Trial.

Author information

1
Neurology Department, Hamad Medical Corporation, Doha, Qatar.
2
Hematology Department, ABC Medical School, Santo André, Brazil.
3
Occupational Health Department, Alexander von Humboldt School, Lima, Peru.
4
Department of Anesthesia and Critical Care, Harvard Medical School Teaching Hospital, Beth Israel Deaconess Medical Center, Boston, MA, USA.
5
Regional University Hospital Jose Maria Cabral y Baez (HRUJMCB), Biomedical and Clinical Research Center (CINBIOCLI), Santiago, Dominican Republic.
6
Health Systems and Policy Department, University of Basel, Swiss TPH, Basel, Switzerland.
7
Department of Pediatric Neurosurgery, SAMIC Pediatric Hospital "Prof. Dr. Juan Pedro Garrahan," Buenos Aires, Argentina.
8
Dentistry Department, Faculty of Health Sciences, University of Brasilia, Brasilia, Brazil.
9
Harvard Medical School, Spaulding Rehabilitation Hospital, Boston, MA, USA.
10
Translational Research & Development, TESARO, Inc., Waltham, MA, USA.
11
Department of Pathology, School of Medicine, Umm Al-Qura University, Mecca, Saudi Arabia.
12
Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.
13
General Hospital Roberto Santos, Salvador, Brazil.
14
Lusíada University Centre's Medical School, Santos, Brazil.
15
Jawaharlal Nehru Medical College, Belgaum, India.
16
Department of Pharmacology & Therapeutics, Hamdard University, Karachi, Pakistan.
17
Peritoneal Oncology Surgery Group, Hospital Marcelino Champagnat, Curitiba, Brazil.
18
Clinical Pharmacy Department, Hamad Medical Corporation, Doha, Qatar.
19
Country Clinic, Andes University, Bogota, Colombia.
20
Onofre Lopes University Hospital, Petropolis, Brazil.
21
Department of Public Health, Montreal University, Montreal, QC, Canada.
22
Minas Gerais Ophthalmology Hospital, Minas Gerais, Brazil.
23
School of Public Health, Department of Health Informatics, Kyoto University, Kyoto, Japan.
24
ABC Medical School, Santo André, Brazil.
25
Internal Medicine Department, Beaumont Hospital, Royal Oak, MI, USA.
26
Oakland University William Beaumont School of Medicine, Rochester, MI, USA.

Abstract

Background and rationale:

Stroke is considered the most common cause of adult disability. Intensive rehabilitation protocols outperform nonintensive counterparts. The subacute stroke phase represents a potential window to recovery. Virtual reality (VR) has been shown to provide a more stimulating environment, allowing for increased patient compliance. However, the quality of current literature comparing VR with standard therapies is limited. Our aim is to measure the impact of VR versus standard therapy on the recovery of the upper limb motor function in patients with stroke in the early subacute recovery phase.

Method:

This is a randomized, controlled trial that will assign 262 patients to tailor-made standard rehabilitation (TMSR) or TMSR plus immersive VR device. The trial will be conducted in an urban rehabilitation clinic in the United States with expertise in the management of poststroke patients. Patients will be 18 to 70 years of age and in the early subacute period (30-90 days post ischemic stroke). The primary outcome will be the change of Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score, measured at baseline and 13 weeks after randomization. The secondary outcome will be the change in the UK Functional Independence Measure and Functional Assessment Measure (UK FIM-FAM) score at the same time points.

Discussion:

If the use of VR in the rehabilitation of patients with stroke proves to have a significant impact on their motor recovery, it will constitute an extremely important step into decreasing the functional impairment associated with stroke and the related health care expense burden.

KEYWORDS:

Fugl-Meyer score; Stroke; motor recovery; rehabilitation; virtual reality

Conflict of interest statement

Declaration of conflicting interests:The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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