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IRCT20200101045970N9 IRCT 2024-05-25 Esfahan University of Medical Sciences Investigating the effect of Nintendo Wii game on the risk of falling in stroke patients Investigating and comparing the effect of therapeutic exercise using Nintendo Wii and conventional physiotherapy on the risk of falling in patients with stroke 2024-04-20 anticipated 42 Complete https://irct.ir/trial/72646 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, after checking the entry and exit criteria, patients are randomly divided into one of two test and control groups. In this study, after consultation with a statistician, it was decided to use the random block method. Using the website https://www.sealedenvelope.com/simple-randomiser/v1/lists, the statistician designed 21 blocks of 2 people, considering that we had 2 groups, using the resulting table and considering We have identified the test group with the letter A and the control group with the letter B. The patients are equally placed in each group according to the order in the table. A person who divides patients into two groups based on this table is unaware of the study, Blinding description: Evaluation is done by a person who is unaware of the groups. The data analyst is also unaware of the groups. N/A stroke. Intervention 1: Intervention group: Conventional physiotherapy, according to previous studies, includes range of motion and stretching exercises related to the lower limb, weight bearing on the involved side, and walking in parallel to the front and back, which are performed for 30 minutes in each session. In addition to conventional treatment, the intervention group is treated with 30 minutes of Wii Fit game in the same session and after a 5-minute break. All games are played while standing on the balance board of the device without the use of aids. The patient plays games under the supervision of a physiotherapist to increase safety. 5 types of games are considered, three games are played in each session. In the first 6 sessions, 3 games of slalom skiing, rope walking and sliding penguin are performed, and in the next 6 sessions, table tilt and balance bubble games replace slalom skiing and walking on the rope. The patient rests for 5 minutes between each game. Intervention 2: Control group: Conventional physiotherapy, according to previous studies, includes range of motion and stretching exercises related to the lower limb, weight bearing on the involved side, and walking in parallel to the front and back, which are performed for 30 minutes in each session. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because of confidentiality
public Dr. Ehsan Ghasemi
Hezar Jerib
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3669 3089 eghasemi@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Ehsan Ghasemi
Hezar Jerib
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3669 3089 eghasemi@rehab.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having a suitable cognitive status (MMSE<24) based on the Persian version of the Mini Mental Status Exam Ability to maintain a standing position without the use of assistive devices for 30 seconds 18 years 85 years Both Visual or hearing impairments History of heart attack or high-risk disease Presence of other neurological disorders such as Parkinson's, neuropathy, epilepsy and seizures Presence of orthopedic disorders The presence of severe pain in the lower limb based on the pain VAS scale between 75 and 100 mm Taking drugs that affect balance function. Participation in other physical therapy interventions G46 Vascular syndromes of brain in cerebrovascular diseases Rehabilitation Rehabilitation Intervention group: Conventional physiotherapy, according to previous studies, includes range of motion and stretching exercises related to the lower limb, weight bearing on the involved side, and walking in parallel to the front and back, which are performed for 30 minutes in each session. In addition to conventional treatment, the intervention group is treated with 30 minutes of Wii Fit game in the same session and after a 5-minute break. All games are played while standing on the balance board of the device without the use of aids. The patient plays games under the supervision of a physiotherapist to increase safety. 5 types of games are considered, three games are played in each session. In the first 6 sessions, 3 games of slalom skiing, rope walking and sliding penguin are performed, and in the next 6 sessions, table tilt and balance bubble games replace slalom skiing and walking on the rope. The patient rests for 5 minutes between each game. Control group: Conventional physiotherapy, according to previous studies, includes range of motion and stretching exercises related to the lower limb, weight bearing on the involved side, and walking in parallel to the front and back, which are performed for 30 minutes in each session. Range of stability. Timepoint: The evaluation of the participants in the study plan will be done before the start of the intervention, after the end of the physiotherapy program and after one month of the treatment program in the rehabilitation faculty of Isfahan University of Medical Sciences. Method of measurement: Synapsys Posturoghraphy System is used. Fear of Falling. Timepoint: The evaluation of the participants in the study plan will be done before the start of the intervention, after the end of the physiotherapy program and after one month of the treatment program in the rehabilitation faculty of Isfahan University of Medical Sciences. Method of measurement: Synapsys Posturoghraphy System is used. Dynamic balance. Timepoint: The evaluation of the participants in the study plan will be done before the start of the intervention, after the end of the physiotherapy program and after one month of the treatment program in the rehabilitation faculty of Isfahan University of Medical Sciences. Method of measurement: The Timed Up and Go (TUG) test is used to evaluate the dynamic balance. Quality of Life. Timepoint: The evaluation of the participants in the study plan will be done before the start of the intervention, after the end of the physiotherapy program and after one month of the treatment program in the rehabilitation faculty of Isfahan University of Medical Sciences. Method of measurement: To evaluate the quality of life, the Stroke Specific Quality of Life Scale questionnaire will be used, the validity and reliability of the Persian version of which has already been proven. Esfahan University of Medical Sciences Approved 2024-04-16 University of Isfahan medical Sciences Hezar Jrib Isfahan Isfehan Iran (Islamic Republic of)