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IRCT20220120053773N1 IRCT 2022-05-14 Psychosomatic Research Center of Imam Khomeini Hospital Effect of virtual reality intervention on mild cognitive impairment EVRIMCI Investigation of Virtual reality’s rehabilitative effects for mild cognitive impairment compared to control group 2022-05-22 anticipated 72 Complete https://irct.ir/trial/61427 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Other design features: Due to the significant effects of dementia on the life quality of the elderly, it is essential to prevent it. People with mild cognitive impairment or MCI (with a prevalence of 15% to 20% in people over 60) are at a much higher risk of developing dementia (Annual rate of dementia in MCI people is between 10% to 15% versus 1% to 2% of this rate in the whole community), and these patients are the target group for the prevention of this disease. [3-1]. It is very important to perform effective interventions to prevent dementia, but unfortunately, no suitable treatment has been discovered for them and drug interventions have not had a significant effect [4]. However, many recent studies have shown that virtual reality-based cognitive rehabilitation can have a significant impact on improving cognitive and motor function in these patients [5]. This rehabilitation, by using sight, touch and movement, provides a suitable space for people to perform daily activities in a "virtual reality" environment [6]. This technology can be adjusted based on the needs and characteristics of patients and has a variety of effects depending on the type, duration, etc. [7]. As a result, there is a discussion about the type, frequency of intervention sessions, duration of each session and the number of sessions required, etc. to achieve optimal results and this is what makes our study unique [9,8]. Also, compared to many previous studies (with a small population limit), the population of this study is much larger and one month follow-up is going to performed after the intervention [9,8]. The extent of its impact on elderly Iranian patients with their level of literacy, culture and understanding and ability to use technology is also questionable. As a result, this study with these distinctive features has not been performed before and conducting it (for the first time in Iran) is very important to help improve the quality of life in the elderly. Refrences: 1. Petersen, R.C., Mid Cognitive Impairment. Continuum (Minneap Minn), 2016 22 (2 Dementia): p. 404-18 2. Eshkor, SA, et al., Mild cognitive impairment and its management in the elderly. Clin Interv Aging, 2015. 10: p. 687-93. 3. Petersen, R.C., et al., Mild Cognitive Disorder: Ten Years Later. Arch Neurol, 2009. 66 (12): p. 1447-55 4. Huckans, M., et al., The effectiveness of cognitive rehabilitation therapies for mild cognitive impairment (MCI) in older adults: Work toward a theoretical model and evidence-based interventions. Neuropsychol Rev, 2013. 23 (1): p. 63-80. 5. Roosink, M., et al. Improve interactive virtual feedback of motion pictures of walking after spinal cord injury: An exploratory study. Restor Neurol Neurosci, 201 6. 34 (2): p. 227-35 6.Rizzo, A.A., et al., Virtual Classroom: A Virtual Reality Environment for Assessing and Rehabilitating Attention Deficit Disorders. 2000. 3 (3): p. 483-499 7.Wu, J., Y. Ma and Z. Ren, Rehabilitation effects of virtual reality technology for mild cognitive impairment: A systematic review by meta-analysis. Front Psychol, 2020. 11: p. 1811 8. Gao Y, Ma L, Lin C, Zhu S, Yao L, Fan H, Gong J, Yan X, Wang T. Effects of virtual reality-based intervention on cognition, motor function, mood, and activities of daily living In patients with chronic stroke: A systematic review and meta-analysis of randomized and controlled trials. Anterior Nerve Aging December 13, 2021; 13: 766525. doi: 10.3389 / fnagi.2021.766525. PMID: 34966267; PMCID: PMC8710683. 9. Wu J, Ma Y, Ren Z. Rehabilitation effects of virtual reality technology for mild cognitive disorders: A systematic review by meta-analysis. Psychological forward. 2020, September 25 11: 1811. doi: 10.3389 / fpsyg.2020.01811. PMID: 33101098; PMCID: PMC7545425, Randomization description: the simple randomization method using random number tables will be used. for allocation concealment Sequentially numbered, sealed, opaque envelopes will be used for this process: The random numbers are placed in the opaque envelopes and the allocation of these opaque envelopes to groups is done randomly, this allocation is confidential and without informing the executor, patient, and investigators, Blinding description: All patients will be informed that they will be participating in a research study, with the permission of them or their caregivers. The consent form will be completed. However, the patients, the project secretary, the evaluator, and the intervenor are blind to grouping. N/A Mild cognitive impairment (MCI) is a common condition in the elderly characterized by impaired memory, attention, and cognitive function with regard to person's age and education. More specifically, MCI is characterized by cognitive complaint by the patient or his family, report of cognitive decline (compared to last year), the presence of obvious cognitive impairment with evident clinical evaluation, the absence of major problems in daily life and the absence of dementia.. Intervention 1: Intervention group: In addition to receiving routine services (physician consultation and diagnostic and therapeutic measures), this group receives virtual reality (VR) rehabilitation 3 days a week (for 1 month and a total of 12 sessions). VR rehabilitation is done in 30-minute sessions, under the supervision of trained experts, with the use of Oculus Quest 2 256G virtual reality headset (manufactured by Oculus from Facebook). This rehabilitation includes two games, "targeting" and "maze", the additional information of which is as follows: In the "oculus VR targeting game", the subject must use a virtual weapon to shot a moving target that appears in the environment. Over time, the difficulty of the task increases. For example, with increasing number of shots, the amount of movement, speed and size of the target changes, and it is expected that the accuracy and speed of action in targeting be affected. The aim of this game is to involve several cognitive processes by activating sensory-motor systems, information processing, speed of action and attention. In the "oculus VR maze game", a movement map is prepared from the VR environment in which the person is located and the person is asked to follow the path of the map to the end. Then the person has to re-enter the maze and reconstruct the movement plan based on what he remembers and move towards the destination. Also, the person faces challenges in his path that he has to overcome. The purpose of this game is to specifically engage cognitive processes related to visual-spatial attention and spatial memory. All members of this group are cognitively assessed before, immediately after and one month after the interventions to evaluate the effectiveness of the intervention in the process of cognitive development and improvement. Intervention 2: Control group: This group receives only the routine services including physician consultation and diagnostic and therapeutic measures. These individuals are cognitively assessed before, immediately after, and one month after receiving the routine services. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is به دلیل خطر افشای اطلاعات شخصی و همچنین عدم امکان رمزگذاری بهینه داده های
public Zahra Vahabi
Roozbeh Hospital, below Lashgar Crossroads, South Kargar Street
Tehran Iran (Islamic Republic of) 13337159140 +98 21 5541 9151 zvahabi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Kimia Darmiani
Roozbeh Hospital, below Lashgar Crossroads, South Kargar Street
Tehran Iran (Islamic Republic of) 13337159140 +98 21 5541 9151 kimia.darmiani80@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age more than 55 years Mild cognitive impairment should be diagnosed by neurologist or psychiatrist according to these items: cognitive complaints coming from the patients or their families, the reporting of a decline in cognitive functioning relative to previous abilities during the past year by the patient or informant, cognitive disorders as evidenced by clinical evaluation(impairment in memory or in another cognitive domain), absence of major repercussions on daily life, absence of dementia Initial Montreal Cognitive Assessment (MoCA) between 21 and 25 55 years no limit Both Addiction or alcohol abuse Another chronic neurologic condition such as drug-resistant epilepsy, Parkinson's disease, dementia (lewy body dementia, vascular dementia, Alzheimer's disease, frontotemporal dementia , etc.), stroke, etc. Psychologic conditions such as Psychosis, personality disorder, major depressive disorder, etc. History of moderate to severe brain injury Rehabilitation Placebo Intervention group: In addition to receiving routine services (physician consultation and diagnostic and therapeutic measures), this group receives virtual reality (VR) rehabilitation 3 days a week (for 1 month and a total of 12 sessions). VR rehabilitation is done in 30-minute sessions, under the supervision of trained experts, with the use of Oculus Quest 2 256G virtual reality headset (manufactured by Oculus from Facebook). This rehabilitation includes two games, "targeting" and "maze", the additional information of which is as follows: In the "oculus VR targeting game", the subject must use a virtual weapon to shot a moving target that appears in the environment. Over time, the difficulty of the task increases. For example, with increasing number of shots, the amount of movement, speed and size of the target changes, and it is expected that the accuracy and speed of action in targeting be affected. The aim of this game is to involve several cognitive processes by activating sensory-motor systems, information processing, speed of action and attention. In the "oculus VR maze game", a movement map is prepared from the VR environment in which the person is located and the person is asked to follow the path of the map to the end. Then the person has to re-enter the maze and reconstruct the movement plan based on what he remembers and move towards the destination. Also, the person faces challenges in his path that he has to overcome. The purpose of this game is to specifically engage cognitive processes related to visual-spatial attention and spatial memory. All members of this group are cognitively assessed before, immediately after and one month after the interventions to evaluate the effectiveness of the intervention in the process of cognitive development and improvement. Control group: This group receives only the routine services including physician consultation and diagnostic and therapeutic measures. These individuals are cognitively assessed before, immediately after, and one month after receiving the routine services. Information processing speed: The amount of speed at which the brain can process and perceive information received from the environment. Timepoint: before intervention, after (1-month) intervention and 1 month after the end of intervention period. Method of measurement: Integrated Cognitive Assessment(ICA). Visual-spatial function: includes the cognitive processes necessary to "identify, integrate and analyze space and visual form, details, structure and spatial relationships" in more than one dimension. Spatial visual skills are required for movement, depth and distance perception, and spatial navigation. Timepoint: before intervention, after (1-month) intervention and 1 month after the end of intervention period. Method of measurement: Addenbrooke's Cognitive Examination III, Integrated Cognitive Assessment(ICA). Verbal memory: refers to the ability of memory to store information verbally. Vocabulary definitions, key details in a story, or the name of a species of living thing are all examples of verbal memory. Timepoint: before intervention, after (1-month) intervention and 1 month after the end of intervention period. Method of measurement: Integrated Cognitive Assessment(ICA). Attention: It is the behavioral and cognitive process of selective focus on one aspect of information, whether subjective or objective, while ignoring other comprehensible information. Timepoint: before intervention, after (1-month) intervention and 1 month after the end of intervention period. Method of measurement: Addenbrooke's Cognitive Examination III. Executive Performance: A set of mental skills that include working memory, flexible thinking, and self-control. Timepoint: before intervention, after (1-month) intervention and 1 month after the end of intervention period. Method of measurement: Addenbrooke's Cognitive Examination III. Verbal psychology: A cognitive function that refers to retrieving information from memory. Timepoint: before intervention, after (1-month) intervention and 1 month after the end of intervention period. Method of measurement: Addenbrooke's Cognitive Examination III. Linguistic function: refers to a person's ability to use sign language. So that one can understand the meaning and also convey it. Timepoint: before intervention, after (1-month) intervention and 1 month after the end of intervention period. Method of measurement: Addenbrooke's Cognitive Examination III. Walking speed: The basic criterion for walking is the initial ability of a person to walk. Walking speed shows us the time required to traverse a certain distance. Timepoint: before intervention, after (1-month) intervention and 1 month after the end of intervention period. Method of measurement: 10m dynamic walking speed test. Gait ability: It is a measured to assess the patient's health in terms of walking which criterion such as the length and height of the step, the appearance of walking, symmetry of steps, continuity of steps, deviation from the path, walking speed, etc. are taken considered. Timepoint: before intervention, after (1-month) intervention and 1 month after the end of intervention period. Method of measurement: Tinetti test. Balance : It is an ability to maintain the line of gravity (vertical line from center of mass) of a body within the base of support and it is essential for success in performing daily life tasks. Timepoint: before intervention, after (1-month) intervention and 1 month after the end of intervention period. Method of measurement: تست تینتی. Life quality: It is the degree to which a healthy person is comfortable and can participate in or enjoy life events. Timepoint: before intervention, after (1-month) intervention and 1 month after the end of intervention period. Method of measurement: SF-36 questionnaire. Psychosomatic Research Center of Imam Khomeini Hospital Approved 2022-03-15 Ethics Committee in Research of Imam Khomeini Hospital Complex - Tehran University of Medical Scienc Imam Khomeini Hospital Complex, Dr. Gharib St, at the end of Keshavarz Blvd., Tehran., Tehran Tehran Iran (Islamic Republic of)