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IRCT20211228053555N1 IRCT 2022-11-26 University of social welfare and rehabilitation sciences Effect of the neurofeedback and cognitive rehabilitation in the elderly The effectiveness of neurofeedback and cognitive rehabilitation on balance and cognitive function in the elderly 2022-11-22 anticipated 40 Complete https://irct.ir/trial/60927 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using sealed envelopes participants were randomly assigned to one of the three groups of study. The envelopes received numbers in advance (coded as 1, 2, and 3), and were opened sequentially, only after the participant’s name was written on the appropriate envelope. Random allocation sequences remained concealed from those enrolling participants into the study to minimize the effects of bias, Blinding description: Data for all subjects were obtained, by an investigator who was blinded to the treatment allocation. N/A The elderly. Intervention 1: Intervention group1: Neurofeedback Neurofeedback therapy involve 16 sessions, with two sessions per week. Neurofeedback training will be conducted using neurofeedback devices with Procomp hardware (Ver.0.5,) and Biography software produced by TAT Technologies Company (Thought Technology Ltd, Canada The method of electrode placement in this protocol is that the active electrode (0.01 reference electrode) will be placed on (the cerebellum) and the grand electrode will be placed on the right ear. Then, in the intervention phase, animation will present to them. As the brain waves of the elderly move away from the intended target (ie, increasing the theta wave and decreasing the beta waves), the animation will stop. To replay the animation, the elderly have to change their brain waves in the direction of the intended target. Intervention 2: Intervention group2: Cognitive rehabilitation In this study, Captain Log cognitive rehabilitation treatment is performed in 16 sessions, 2 times a week for 60 minutes each time.The Captain Log program is one of the software programs designed by Train Brain in the United States to rehabilitate and enhance cognitive functions. This set has 2000 different programs and assignments and includes basic cognitive skills and superior skills. Also, this software set has three levels: simple, medium and difficult, which are determined according to the subject's condition. Intervention 3: Intervention group 3:Neurofeedback + Cognitive Neurofeedback therapy In total, this group has 4 treatment sessions per week, including two neurofeedback sessions and two cognitive therapy sessions.Neurofeedback therapy involve 16 sessions, with two sessions per week. Captain Log cognitive rehabilitation treatment is performed in 16 sessions, 2 times a week for 60 minutes each time. Intervention 4: Control group: This group does not receive treatment. Only every week their conditions are checked by phone. Yes - There is a plan to make this available What will be shared: Demographic information and information on the main outcome When: Start of access period from 1401 To whom: Researchers working in academic institutions and clinics Conditions: Use for further research and review articles Where to obtain: Seyed Abolfazl Mousavi How to obtain: Two weeks to review the request and check the purpose of receiving the data Comments: Because the condition we are studying is not a disease, we leave the ICD-10 code and ICD-10 code description fields empty according to your guidline.
public Seyed Abolfazl Mousavi
No. 7, Baran Building , Falsafy Alley, Between Mirdamad and Zafar Ave, Shariati St,Tehran Town.
Tehran Iran (Islamic Republic of) 1985713871 +98 919 300 3160 seyed.abalfazl@gmail.com Movafaghiyat Clinic scientific Seyed Abolfazl Mousavi
No. 7, Baran Building , FalsaFy Alley, Between Mirdamad and Zafar Ave, Shariati St,Tehran Town.
Tehran Iran (Islamic Republic of) 1985713871 +98 919 300 3160 seyed.abalfazl@gmail.com Movafaghiyat clinic Iran (Islamic Republic of) Those elderly who do not have cranial implants Those elderly who are able to walk independently without assistive devices Those elderly who have conscious consent to participate in research Those elderly who have no history of attending psychotherapy and neurofeedback sessions 65 years 74 years Both old people with a definite diagnosis of neurological disorders, orthopedic disorders and cardiovascular and respiratory diseases old people with a visual or vestibular impairment, or those who taking medications which cause balance problems the elderly who had a score below 7 on the Brief cognitive test Personal reluctance to continue treatment Rehabilitation Rehabilitation Rehabilitation Rehabilitation Intervention group1: Neurofeedback Neurofeedback therapy involve 16 sessions, with two sessions per week. Neurofeedback training will be conducted using neurofeedback devices with Procomp hardware (Ver.0.5,) and Biography software produced by TAT Technologies Company (Thought Technology Ltd, Canada The method of electrode placement in this protocol is that the active electrode (0.01 reference electrode) will be placed on (the cerebellum) and the grand electrode will be placed on the right ear. Then, in the intervention phase, animation will present to them. As the brain waves of the elderly move away from the intended target (ie, increasing the theta wave and decreasing the beta waves), the animation will stop. To replay the animation, the elderly have to change their brain waves in the direction of the intended target. Intervention group2: Cognitive rehabilitation In this study, Captain Log cognitive rehabilitation treatment is performed in 16 sessions, 2 times a week for 60 minutes each time.The Captain Log program is one of the software programs designed by Train Brain in the United States to rehabilitate and enhance cognitive functions. This set has 2000 different programs and assignments and includes basic cognitive skills and superior skills. Also, this software set has three levels: simple, medium and difficult, which are determined according to the subject's condition. Intervention group 3:Neurofeedback + Cognitive Neurofeedback therapy In total, this group has 4 treatment sessions per week, including two neurofeedback sessions and two cognitive therapy sessions.Neurofeedback therapy involve 16 sessions, with two sessions per week. Captain Log cognitive rehabilitation treatment is performed in 16 sessions, 2 times a week for 60 minutes each time.. Control group: This group does not receive treatment. Only every week their conditions are checked by phone. Cognitive function. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Mini-Mental State Examination, Montreal Cognitive Assessment. Balance. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Timed Up and Go test, the Berg Balance Scale (BBS). Risk of falling. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Tinetti balance score. University of social welfare and rehabilitation sciences Approved 2021-12-27 Ethics committee of University of Social Welfare and Rehabilitation Sciences kodakyar Ave, Daneshjoo Blvd, Evin,Tehran, University of Social Welfare and Rehabilitation Science Tehran Tehran Iran (Islamic Republic of)