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IRCT20241016063383N1 IRCT 2024-10-19 University of social welfare and rehabilitation sciences Effect of therapeutic exercise using virtual reality on the performance of stroke patients Effect of specific exercise training using virtual reality on lower extremity function of stroke patients 2024-11-30 anticipated 60 Complete https://irct.ir/trial/79593 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The grouping will be done by a simple random method of coin toss and the patients will be randomly divided into two control and intervention groups by tap or line method and will be treated in each group according to the specific method of that group. N/A Stroke. Intervention 1: The tool used in this study is the Sana virtual reality system, which provides the ability to perform exercises in different fields of rehabilitation. The system used, has a Kinect camera (it is a motion detection system based on photography) that records motion data from the patient's limb movements and then analyzes the motion data by a pre-processing unit. It also uses a 32-inch monitor that has been trained to show the virtual space to the patient and provide appropriate audio and visual feedback in each exercise. Intervention group: The participants will be treated 3 days a week and every other day for 10 sessions. In the specific therapeutic exercise, each exercise will be done in three sets of ten. In addition to receiving electrotherapy and general therapeutic exercise, the intervention group will perform specific therapeutic exercise using virtual reality, 10 sessions of each exercise in three sets of ten. Functional tests related to the study once before the treatment and once after 10 treatment sessions will be taken from people and the results will be compared. Specific therapeutic exercises include: trunk control exercises, weight shifting, bearing weight on the non-affected limb and bringing the knee of the affected limb to the desired goal, bearing weight on the affected limb and bringing the leg of the other limb to the desired goal and bringing the hand and foot of the affected side alternately to the intended target. Intervention 2: Control group: The participants will be treated 3 days a week and for 10 sessions every other day. The control group will receive 10 conventional physiotherapy sessions including electrotherapy, general therapeutic exercise and specific therapeutic exercise. In the specific therapeutic exercise, each exercise will be done three sets of ten .Specific therapeutic exercises include: trunk control exercises, weight shifting, bearing weight on the non-affected limb and bringing the knee of the affected limb to the desired goal, bearing weight on the affected limb and bringing the leg of the other limb to the desired goal and bringing the hand and foot of the affected side alternately to the intended target. Yes - There is a plan to make this available What will be shared: Data on key variables and their statistical results can be shared after de-identifying individuals. When: The access period starts 6 months after the results are published To whom: Researchers in all levels and disciplines Conditions: The requester of the documents will be able to use the data only by mentioning the source and the name of the researcher. Where to obtain: To access the information, send a message to this email: nikazarrabi97@gmail.com How to obtain: The applicant should express his/her request by sending an email and she will be answered within a week. Comments:
public Nika Zarrabi
No.17 ,East Biglarpour, Jahantab, East Akhlaghi, Kaveh blvd, Dolat street, Tehran
Tehran Iran (Islamic Republic of) 1939945511 +98 21 2276 4272 nikazarrabi97@gmail.com University of social welfare and rehabilitation sciences scientific Nika Zarrabi
No.17 ,East Biglarpour, Jahantab, East Akhlaghi, Kaveh blvd, Dolat street, Tehran
Tehran Iran (Islamic Republic of) 1939945511 +98 21 2276 4272 nikazarrabi97@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) The patient has suffered a stroke for the first time and has been confirmed by a neurologist. At least 6 months and at most 36 months have passed since the stroke Spasticity should not be excessive (with a score of 3 and 4 in the MAS questionnaire) The patient should be in a favorable condition in terms of understanding and cognition and should be able to communicate. The patient should be able to stand independently or with assistive devices (cane, walker) 40 years 80 years Both The patient is not in a stable medical condition (heart problems, blood pressure, breathing). The patient has a history of other neurological problems or psychological problems Use of botulinum toxin in the past 6 months Surgery in the last 6 months Apraxia disorder The presence of orthopedic and skeletal disorders in a person that prevents the desired movements. Vestibular disorders Visual disorders I69.4 Sequelae of stroke, not specified as haemorrhage or infarction Rehabilitation Rehabilitation The tool used in this study is the Sana virtual reality system, which provides the ability to perform exercises in different fields of rehabilitation. The system used, has a Kinect camera (it is a motion detection system based on photography) that records motion data from the patient's limb movements and then analyzes the motion data by a pre-processing unit. It also uses a 32-inch monitor that has been trained to show the virtual space to the patient and provide appropriate audio and visual feedback in each exercise. Intervention group: The participants will be treated 3 days a week and every other day for 10 sessions. In the specific therapeutic exercise, each exercise will be done in three sets of ten. In addition to receiving electrotherapy and general therapeutic exercise, the intervention group will perform specific therapeutic exercise using virtual reality, 10 sessions of each exercise in three sets of ten. Functional tests related to the study once before the treatment and once after 10 treatment sessions will be taken from people and the results will be compared. Specific therapeutic exercises include: trunk control exercises, weight shifting, bearing weight on the non-affected limb and bringing the knee of the affected limb to the desired goal, bearing weight on the affected limb and bringing the leg of the other limb to the desired goal and bringing the hand and foot of the affected side alternately to the intended target. Control group: The participants will be treated 3 days a week and for 10 sessions every other day. The control group will receive 10 conventional physiotherapy sessions including electrotherapy, general therapeutic exercise and specific therapeutic exercise. In the specific therapeutic exercise, each exercise will be done three sets of ten .Specific therapeutic exercises include: trunk control exercises, weight shifting, bearing weight on the non-affected limb and bringing the knee of the affected limb to the desired goal, bearing weight on the affected limb and bringing the leg of the other limb to the desired goal and bringing the hand and foot of the affected side alternately to the intended target. Changes in the individual's static and dynamic balance score based on the Berg Balance Scale short test. Timepoint: Once before the intervention and once after 10 treatment sessions. Method of measurement: Short Berg Balance Scale. Functional changes of the lower limb using the Timed up and go test. Timepoint: Once before the intervention and once after 10 treatment sessions. Method of measurement: Timed up and Go test. Determining the ability to perform daily activities using the modified Barthel scale. Timepoint: Once before the intervention and once after 10 treatment sessions. Method of measurement: modified Barthel Index of ADL. University of social welfare and rehabilitation sciences Approved 2024-09-23 Ethics Committee of the University of Social Welfare and rehabilitation sciences No.17, East Biglarpor, Jahantab Ave, East Akhlaghi Ave, Kaveh Blvd, Dolat Ave. Tehran Tehran Iran (Islamic Republic of)