NCT04533308CompletedNot Applicable
The Impact of Virtual Reality on the Emotional State of Patients With Aphasia During Rehabilitation.
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia2 sites in 2 countries40 target enrollmentStarted: August 20, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- The absence of severe adverse reactions
Study Overview
Brief Summary
The aim of the study is to determine virtual reality (VR) impact during standard program of rehabilitation on emotional state of patients with aphasia.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Mild or moderate aphasia of any type
- •Russian is primary language
- •At least 2 weeks post cardio-vascular accident (ischemic or hemorrhagic stroke) or head injury of any location
- •Have a history of only one stroke
- •Medically stable
Exclusion Criteria
- •Associated severe cognitive deficits and psychiatric disorders which prevent patients understanding of the informed consent
- •Medical history of severe visual or hearing impairment
- •Comorbid neurological diagnosis (e.g. epilepsy, multiple sclerosis, Parkinson disease, dementia)
- •Unable to perform the required exercises due to severe motor, sensory or cognitive deficit (memory, attention, executive functioning, apraxia, regulatory and planning activities etc.) and medical problems (for example, anyone meeting New York Heart Association Class IV criteria, hospitalization for myocardial infarction or heart surgery within 120 days, severe cardiomyopathy or documented serious and unstable cardiac arrhythmias)
- •Drug or alcohol addiction within the last 6 months.
- •Significant current psychiatric illness defined as affective disorder unresponsive to medication or bipolar affective disorder, psychosis, schizophrenia or suicidality
- •Current participation in another interventional trial
Outcomes
Primary Outcomes
The absence of severe adverse reactions
Time Frame: From admission to discharge, up to 3 weeks
Assessed by a self-reported form and physiological parameters
Secondary Outcomes
- Visual Analog Mood Scale (VAMS)(From admission to discharge, up to 3 weeks)
- Three-level European quality of life five-dimensional questionnaire(From admission to discharge, up to 3 weeks)
- 10 - Stroke Aphasic Depression Questionnaire (SADQH-10)(From admission to discharge, up to 3 weeks)
- Perceived Stress Scale (PSS)(From admission to discharge, up to 3 weeks)
- Lüscher Color Test(From admission to discharge, up to 3 weeks)
- Aphasic Depression Rating Scale (ADRS)(From admission to discharge, up to 3 weeks)
Investigators
Eduard Novak
MD, MSc
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Study Sites (2)
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