Clinical trial NCT04681235: Virtual Reality Training Affects on Motor Functions and Mental Health in Stroke Patients
Official title: Virtual Reality Training Affects on Motor Functions and Mental Health in Stroke Patients: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Motor Disorders
Affective Symptoms
Gait Disorder, Sensorimotor
Keywords: Stroke
Virtual reality
Rehabilitation
Motion capture
Lead sponsor: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postural stability test (Grail Motekforce)
timeFrame: Change from baseline at 2 weeks
measure: Six-minute walk test (6MWT) (Grail Motekforce)
timeFrame: Change from baseline at 2 weeks
measure: Beck Depression Inventory
timeFrame: Change from baseline at 2 weeks
measure: State-Trait Anxiety Inventory
timeFrame: Change from baseline at 2 weeks
Secondary outcomes:
measure: Standing Balance Test
timeFrame: Change from baseline at 2 weeks
measure: Berg Balance Scale
timeFrame: Change from baseline at 2 weeks
measure: Timed Up and Go Test
timeFrame: Change from baseline at 2 weeks
measure: Hauser Ambulation Index
timeFrame: Change from baseline at 2 weeks
measure: Rivermead Activities of Daily Living Scales
timeFrame: Change from baseline at 2 weeks
measure: Functional Independence Measure
timeFrame: Change from baseline at 2 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
Study officials:
affiliation: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
name: Marina A Shurupova
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
name: Alina D Aizenshtein
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
name: Galina Ivanova, Prof.
role: STUDY_CHAIR
affiliation: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
name: Nadezhda L Cherepahina, PhD
role: PRINCIPAL_INVESTIGATOR
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