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

Primary Purpose

Stroke, Motor Disorders, Affective Symptoms

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Training on VR
Sponsored by
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke focused on measuring Stroke, Virtual reality, Rehabilitation, Motion capture

Eligibility Criteria

30 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Training Group

Arm Description

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

Outcomes

Primary Outcome Measures

Postural stability test (Grail Motekforce)
The subject's ability to remain balanced under four different conditions is evaluated (cm/s).
Six-minute walk test (6MWT) (Grail Motekforce)
The 6-minute walk test evaluates how much distance a subject can cover in six minutes (m).
Beck Depression Inventory
Measures the severity of depression (0-63; 30-63 scores indicate severe depression)
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

Secondary Outcome Measures

Standing Balance Test
Examines the patient's ability to maintain an upright position (0-4, where 0 - can't stand)
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
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
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)
Rivermead Activities of Daily Living Scales
Assesses self-service and two types of domestic activities, maximum scores (90) indicate independence in daily living activity
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)

Full Information

First Posted
December 18, 2020
Last Updated
December 22, 2020
Sponsor
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
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1. Study Identification

Unique Protocol Identification Number
NCT04681235
Brief Title
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
July 27, 2020 (Actual)
Study Completion Date
July 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Motor Disorders, Affective Symptoms, Gait Disorder, Sensorimotor
Keywords
Stroke, Virtual reality, Rehabilitation, Motion capture

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training Group
Arm Type
Experimental
Arm Description
Training Group recieved 10 sessions on VR (Grail Motekforce, Netherlands) during two weeks. One session lasted 40 minuties.
Intervention Type
Other
Intervention Name(s)
Training on VR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postural stability test (Grail Motekforce)
Description
The subject's ability to remain balanced under four different conditions is evaluated (cm/s).
Time Frame
Change from baseline at 2 weeks
Title
Six-minute walk test (6MWT) (Grail Motekforce)
Description
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
Title
Beck Depression Inventory
Description
Measures the severity of depression (0-63; 30-63 scores indicate severe depression)
Time Frame
Change from baseline at 2 weeks
Title
State-Trait Anxiety Inventory
Description
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
Secondary Outcome Measure Information:
Title
Standing Balance Test
Description
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
Title
Berg Balance Scale
Description
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
Title
Timed Up and Go Test
Description
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
Title
Hauser Ambulation Index
Description
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
Title
Rivermead Activities of Daily Living Scales
Description
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
Title
Functional Independence Measure
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina A Shurupova
Organizational Affiliation
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alina D Aizenshtein
Organizational Affiliation
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Galina Ivanova, Prof.
Organizational Affiliation
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nadezhda L Cherepahina, PhD
Organizational Affiliation
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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

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