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IRCT20231031059916N1 IRCT 2023-11-12 Tehran University of Medical Sciences Evaluating Immersive Virtual Reality Training on Dynamic Stability, Gait Parameters, and User Experience of Patients with Cerebrovascular Accidents: A Study Protocol for a Randomized Controlled Trial Evaluating Immersive Virtual Reality Training on Dynamic Stability, Gait Parameters, and User Experience of Patients with Cerebrovascular Accidents: A Study Protocol for a Randomized Controlled Trial 2024-01-21 anticipated 32 Complete https://irct.ir/trial/73557 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization process is done by the study coordinator, after determining the exact number of participants, he gives a code to each of them using a table of random numbers generated by the computer. The researcher puts his hand on one of the numbers and moves in a predetermined direction and records the numbers and assigns them to two groups, which leads to the equal allocation of participants to two groups. N/A Cerebrovascular accidents/ ischemic stroke. Intervention 1: Intervention group: The VR training group will receive 30 min per day for 3 weeks (5 days/week) of VR-assisted gait rehabilitation. participants will be instructed on the option selection process by focusing on the desired options for a brief duration. Once the participants put on the VR glasses and headset, they can freely move their heads and explore the virtual environment, allowing them to observe their surroundings, including the ground and their feet. Each participant will engage in a 30-minute session of VR utilization. Participants will be assigned training scores based on their successful fulfillment of the specific requirements for each stage within the different training scenarios. The virtual training scenes within the study can be flexibly customized based on the individual needs and preferences of the participants. Additionally, the difficulty level of the VR scenes can be adaptively modified according to each participant's lower extremity motor ability, enabling a personalized and tailored VR experience. Intervention 2: Control group: Participants will receive 30 min per day for 3 weeks (5 days/week) of functional gait rehabilitation training. The functional gait rehabilitation training may include (1) walking and picking up various objects from the ground, (2) walking on a nonlevel surface, (3) walking a slalom, (4) stepping in hoops, and (5) stepping over a stick that is fixed between pylons. They also will receive 30 min per week for 3 weeks of regular active exercise training. The physiotherapist in charge will make necessary adjustments to the exercise intensity and type based on the individual patient's abilities. They will also assess and monitor the progress, safety, and quality of movement exhibited by the patient during the exercise sessions. Yes - There is a plan to make this available What will be shared: If a judge or an expert wants data and information, the data will be provided without the names of the participants by referring to the corresponding author or project manager. When: If a judge or an expert wants data and information, the data will be provided without the names of the participants by referring to the corresponding author or project manager. To whom: If a judge or an expert wants data and information, the data will be provided without the names of the participants by referring to the corresponding author or project manager. Conditions: If a judge or an expert wants data and information, the data will be provided without the names of the participants by referring to the corresponding author or project manager. Where to obtain: If a judge or an expert wants data and information, the data will be provided without the names of the participants by referring to the corresponding author or project manager (Amirhossein Memari, Email: mehranamir@yahoo.com). How to obtain: If a judge or an expert wants data and information, the data will be provided without the names of the participants by referring to the corresponding author or project manager via Email (Amirhossein Memari, Email: mehranamir@yahoo.com). Comments:
public Amirhossein Memari
No. 7, in front of Shariati Hospital clinic, after Geisha Bridge exit, Jalal Al Ahmad Street, Tehran
Tehran Iran (Islamic Republic of) 1417653761 +98 21 8863 0227 mehranamir@yahoo.com Tehran University of Medical Sciences scientific Vahideh Moradi
Jalal-Al-Ahmad street
Tehran Iran (Islamic Republic of) 1417653761 +98 21 8863 0227 vahideh.moradi@gamil.com Iran-helal isntitute of applied science and technology Iran (Islamic Republic of) Patients with ischemic stroke were diagnosed according to WHO criteria Between 30 and 80 years old Within 6-12 months after stroke onset before enrollment Ability to walk without support or assistive device for at least 10 meters Adequate communication skills to understand and follow orders 30 years 80 years Both Patients with Pregnancy Patients with an injury or cognitive disorder who cannot follow instructions and training Patients with Cardiac arrhythmias or a pacemaker Patients with Major vascular disease Patients with Impaired consciousness and mental disorders requiring drug therapy Patients with Severe visual impairments Y80.1 Therapeutic (nonsurgical) and rehabilitative physical medicine devices associated with adverse incidents Rehabilitation Rehabilitation Intervention group: The VR training group will receive 30 min per day for 3 weeks (5 days/week) of VR-assisted gait rehabilitation. participants will be instructed on the option selection process by focusing on the desired options for a brief duration. Once the participants put on the VR glasses and headset, they can freely move their heads and explore the virtual environment, allowing them to observe their surroundings, including the ground and their feet. Each participant will engage in a 30-minute session of VR utilization. Participants will be assigned training scores based on their successful fulfillment of the specific requirements for each stage within the different training scenarios. The virtual training scenes within the study can be flexibly customized based on the individual needs and preferences of the participants. Additionally, the difficulty level of the VR scenes can be adaptively modified according to each participant's lower extremity motor ability, enabling a personalized and tailored VR experience. Control group: Participants will receive 30 min per day for 3 weeks (5 days/week) of functional gait rehabilitation training. The functional gait rehabilitation training may include (1) walking and picking up various objects from the ground, (2) walking on a nonlevel surface, (3) walking a slalom, (4) stepping in hoops, and (5) stepping over a stick that is fixed between pylons. They also will receive 30 min per week for 3 weeks of regular active exercise training. The physiotherapist in charge will make necessary adjustments to the exercise intensity and type based on the individual patient's abilities. They will also assess and monitor the progress, safety, and quality of movement exhibited by the patient during the exercise sessions. Non-linear measures of walking including the Lyapunov exponent and Floquet multipliers calculating local and orbital stability. Timepoint: All participants in the study will be measured before the start of the study, after the intervention (3 weeks later), and 2 months after the treatment. Method of measurement: Lyapunov exponent formula: y(i)= 1/Δt<Ln⁡〖 d_j (i)〗> Floquet multipliers formula: S_(k+1 )=F(S_k ). User experience (UX) evaluated by applying the AttarkDiff questionnaire. Timepoint: All participants in the study will be measured before the start of the study, after the intervention (3 weeks later), and 2 months after the treatment. Method of measurement: User experience (UX) evaluated by applying the AttarkDiff questionnaire. The timed Up and Go test (TUG) to assess mobility in adults or predict their risk of falls. Timepoint: All participants in the study will be measured before the start of the study, after the intervention (3 weeks later), and 2 months after the treatment. Method of measurement: The timed Up and Go test (TUG), subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. The 6-Minute Walk Test. Timepoint: All participants in the study will be measured before the start of the study, after the intervention (3 weeks later), and 2 months after the treatment. Method of measurement: The 6-Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. Assessing the virtual environment's effects on an individual's health. Timepoint: All participants in the study will be measured before the start of the study, after the intervention (3 weeks later), and 2 months after the treatment. Method of measurement: The Simulator Sickness Questionnaire. Fear of falling. Timepoint: All participants in the study will be measured before the start of the study, after the intervention (3 weeks later), and 2 months after the treatment. Method of measurement: The Falls Efficacy Scale-International (FES-I). Evaluating balance. Timepoint: All participants in the study will be measured before the start of the study, after the intervention (3 weeks later), and 2 months after the treatment. Method of measurement: The Berg Balance scale (BBS). Tehran University of Medical Sciences Approved 2023-02-18 Ethics committee of Tehran University of Medical Sciences No. 23, 16 Azar Ave., Keshavarz Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)