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The aim of the study is to determine virtual reality (VR) impact during standard program of rehabilitation on emotional state of patients with aphasia.
Aim 1: To test the safety of virtual reality in a vulnerable population of patients with aphasia during rehabilitation. Participants will be alternately assigned to receiving a relaxation session in VR every working day during a standard course of rehabilitation.
Aim 2: To test the preliminary efficacy of combining VR with the course of rehabilitation to promote emotional improvements in patients with aphasia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR intervention | Experimental | Participants will have a session in VR for 20-30 minutes each working day. They can choose natural 360-degrees scenes from different locations in the world with or without interactions with animals. The equipment will include HTC Vive (HTC Corporation). |
|
| Control | No Intervention | Patients in the control group will not receive any psychological interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relaxation in virtual reality | Behavioral | Natural 360-degrees scenes from different locations in the world with or without interactions with animals in the virtual reality |
|
| Measure | Description | Time Frame |
|---|---|---|
| The absence of severe adverse reactions | Assessed by a self-reported form and physiological parameters | From admission to discharge, up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 10 - Stroke Aphasic Depression Questionnaire (SADQH-10) | Scores range from 0 to 30 with lower scores denoting better outcomes. | From admission to discharge, up to 3 weeks |
| Visual Analog Mood Scale (VAMS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vadim D Daminov, Prof | Pirogov National Medical and Surgical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pirogov National Medical and Surgical Center | Moscow | 105037 | Russia |
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1 year after completion of the trial
upon request
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Scores range from 0 to 10 with lower scores denoting better outcomes.
| From admission to discharge, up to 3 weeks |
| Perceived Stress Scale (PSS) | Scores range from 0 to 50 with lower scores denoting better outcomes. | From admission to discharge, up to 3 weeks |
| Three-level European quality of life five-dimensional questionnaire | There are five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Patients choice results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describe the health status. | From admission to discharge, up to 3 weeks |
| Aphasic Depression Rating Scale (ADRS) | Scores range from 0 to 36 with lower scores denoting better outcomes. | From admission to discharge, up to 3 weeks |
| Lüscher Color Test | Eight different colored cards are place in order of preference. The descriptive statements formed by Lüscher for each color were used to interpret the results. | From admission to discharge, up to 3 weeks |
| ID | Term |
|---|---|
| D001037 | Aphasia |
| D000342 | Affective Symptoms |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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