An interventional study of Training on VR in Stroke, Motor Disorders and Affective Symptoms, sponsored by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health. Completed at 1 site in Russian Federation. Open to participants aged 30 Years to 79 Years. Per ClinicalTrials.gov, last updated 2020-12-23.
Sponsored by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health · Not applicable, Interventional, and Diagnostic
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 34 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
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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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Training Group recieved 10 sessions on VR (Grail Motekforce, Netherlands) during two weeks. One session lasted 40 minuties.
Other: 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.
Postural stability test (Grail Motekforce)
The subject's ability to remain balanced under four different conditions is evaluated (cm/s).
Time frame: Change from baseline at 2 weeks
Six-minute walk test (6MWT) (Grail Motekforce)
The 6-minute walk test evaluates how much distance a subject can cover in six minutes (m).
Time frame: Change from baseline at 2 weeks
Beck Depression Inventory
Measures the severity of depression (0-63; 30-63 scores indicate severe depression)
Time frame: Change from baseline at 2 weeks
State-Trait Anxiety Inventory
Examines two types of anxiety - state anxiety (anxiety about an event) and trait anxiety (anxiety level as a personal characteristic) with the score range from 20 to 80, where higher scores correspond to greater anxiety
Time frame: Change from baseline at 2 weeks
Standing Balance Test
Examines the patient's ability to maintain an upright position (0-4, where 0 - can't stand)
Time frame: Change from baseline at 2 weeks
Berg Balance Scale
Relates to evaluation of static and dynamic balance, consists of 14 tasks, ranging from standing up from a sitting position, to standing on one foot
Time frame: Change from baseline at 2 weeks
Timed Up and Go Test
Examines functional mobility and requires a patient to stand up, walk 3 meters, turn, walk back, and sit down; result is obtained in seconds
Time frame: Change from baseline at 2 weeks
Hauser Ambulation Index
Assess mobility by evaluating the time and degree of assistance required to walk a 8-m distance as quickly and safely as possible, with scores that range from 0 (asymptomatic) to 10 (bedridden)
Time frame: Change from baseline at 2 weeks
Rivermead Activities of Daily Living Scales
Assesses self-service and two types of domestic activities, maximum scores (90) indicate independence in daily living activity
Time frame: Change from baseline at 2 weeks
Functional Independence Measure
Examines the functional status of the patient in 18 domains related to cognitive and motor functions up to the maximum in 126 scores (independence in daily life)
Time frame: Change from baseline at 2 weeks
Plan to share: No
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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health