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Virtual Reality Training Affects on Motor Functions and Mental Health in Stroke Patients

NCT ID: NCT04681235

Last Updated: 2020-12-23

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

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-07-27

Brief Summary

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In our study, we tested the hypothesis of the safe effect applicability of motor training in the immersion high-tech polymodal VR system not only on the parameters of balance, gait, and motor status of the patient, but also on his cognitive functions and mental health in patients with a degree of disability no more than 3 points on a scale Rankin.

Detailed Description

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The neurological consequences of stroke cover the motor, sensory, visual, affective, cognitive and speech spheres. 55-75% of stroke survivors suffer from motor impairments, caused, inter alia, by hemiparesis, which substantially reduce the quality of their life. In addition, neurocognitive functions, especially memory, visual-constructive abilities and executive functions, are often affected by stroke. Cognitive impairments appear in 83% patients in at least one cognitive domain, whereas in 50% patients appear in multiple (≥3) domains. These disorders affect the quality of life of patients, their skills of daily activity (the ability to go to the store, prepare food, plan their actions for organizing a daily routine), social adaptation. One of the rehabilitation methods that are comprehensively suitable for the recovering on of stroke consequences is the intervention using virtual reality. The VR method is used for the rehabilitation of stroke patients with various motor and neurocognitive deficits: one-sided spatial ignorance, disorders of attention, memory, mood, visual-spatial functions, and constructive abilities.

In our study, we tested the hypothesis of the applicability of the safe effect of motor training in the immersion high-tech polymodal VR system not only on the parameters of balance, gait, and motor status of the patient, but also on his cognitive functions and mental health in patients with a degree of disability no more than 3 score on a modified Rankin Scale.

Stroke patients participated in the study in Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health in Moscow, Russia. The study was run between October 2019 and July 2020 and was approved by a local ethic committee and followed principles of the Declaration of Helsinki. The patients stayed in a 24-hour hospital and underwent a rehabilitation course. This course included a VR Trainig of 10 sessions of 40 minutes each, which the patients took over two weeks. VR training was conducted on the GRAIL system equipment (Motekforce, Netherlands), consisting of a semi-cylindrical screen, treadmill, 10 infrared cameras (Vicon, UK) and reflective markers, and software providing biofeedback in real time. For complex recovery in VR, exercises stimulate the motor, cognitive and behavioral spheres, including visual-spatial orientation, the process of attention (with one and duai-task), executive functions, lowering the level of anxiety, hand-eye coordination and balance.Training applications were based on the therapeutic goals for every patient, according to postural stability and gait adaptation.

Before and after the end of the training, the patient's condition was assessed, including measurements in motor and daily living activity, measurements in mental health, measurements in Virtual Reality.

Conditions

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Stroke Motor Disorders Affective Symptoms Gait Disorder, Sensorimotor

Keywords

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Stroke Virtual reality Rehabilitation Motion capture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Training Group

Training Group recieved 10 sessions on VR (Grail Motekforce, Netherlands) during two weeks. One session lasted 40 minuties.

Group Type EXPERIMENTAL

Training on VR

Intervention Type OTHER

The training is aimed at improving the functioning of the motor sphere, including balance, gait, and upper limb function, as well as increasing the level of motivation and reducing the level of anxiety and depression. Game applications were selected based on therapeutic tasks of motor recovery.

Interventions

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Training on VR

The training is aimed at improving the functioning of the motor sphere, including balance, gait, and upper limb function, as well as increasing the level of motivation and reducing the level of anxiety and depression. Game applications were selected based on therapeutic tasks of motor recovery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

with a stroke, transferred at least 2 weeks ago; with no history of neurological or psychiatric disorders; able to maintain an upright posture and walk without support or with minimal support for at least 30 minutes; with stable hemodynamics;

Exclusion Criteria

not having epileptic activity; not having serious ophthalmic disorders; less than 24 scores in MoCA
Minimum Eligible Age

30 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marina A Shurupova

Role: PRINCIPAL_INVESTIGATOR

Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

Alina D Aizenshtein

Role: PRINCIPAL_INVESTIGATOR

Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

Galina Ivanova, Prof.

Role: STUDY_CHAIR

Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

Nadezhda L Cherepahina, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

Locations

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Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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VR001

Identifier Type: -

Identifier Source: org_study_id