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

Stroke Clinical Trial

Official title:

Virtual Reality Training Affects on Motor Functions and Mental Health in Stroke Patients: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04681235
• Other study ID #: VR001
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: July 27, 2020

Study information

• Verified date: December 2020
• Source: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 27, 2020
• Est. primary completion date: July 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Affective Symptoms
• Disease
• Gait Disorder, Sensorimotor
• Gait Disorders, Neurologic
• Motor Disorders
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health	Moscow

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural stability test (Grail Motekforce)	The subject's ability to remain balanced under four different conditions is evaluated (cm/s).	Change from baseline at 2 weeks
Primary	Six-minute walk test (6MWT) (Grail Motekforce)	The 6-minute walk test evaluates how much distance a subject can cover in six minutes (m).	Change from baseline at 2 weeks
Primary	Beck Depression Inventory	Measures the severity of depression (0-63; 30-63 scores indicate severe depression)	Change from baseline at 2 weeks
Primary	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	Change from baseline at 2 weeks
Secondary	Standing Balance Test	Examines the patient's ability to maintain an upright position (0-4, where 0 - can't stand)	Change from baseline at 2 weeks
Secondary	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	Change from baseline at 2 weeks
Secondary	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	Change from baseline at 2 weeks
Secondary	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)	Change from baseline at 2 weeks
Secondary	Rivermead Activities of Daily Living Scales	Assesses self-service and two types of domestic activities, maximum scores (90) indicate independence in daily living activity	Change from baseline at 2 weeks
Secondary	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)	Change from baseline at 2 weeks