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IRCT20180213038710N2 IRCT 2023-09-10 Tabriz University of Medical Sciences The effectiveness of implementation of Rehacom Cognitive Rehabilitation Therapy on cognitive function of the elderly with normal cognition, MCI and mild Alzheimer: A pilot study The effectiveness of the implementation of Rehacom Cognitive Rehabilitation Therapy on cognitive function of the elderly with normal cognition, MCI, and mild Alzheimer: A pilot study 2023-11-22 anticipated 72 Complete https://irct.ir/trial/72412 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to evenly distribute people based on their cognitive status into two intervention and control groups; the participants will be divided into three groups based on the scores obtained from the MoCA form, the elderly with normal cognitive status and the elderly with mild cognitive impairment (MCI) and elderly with mild Alzheimer's will be randomly assigned in two intervention and control groups. The random assignment of the elderly will be done based on the cognitive and educational status of the elderly. The Stratified random block method will be done based on education level (diploma, Associate/Bachelor degree, Master's degree or higher) and cognitive status (normal, MCI, mild Alzheimer's) and participants allocated to intervention and control groups. Based on education level and cognitive status, 6 stratifications will be formed. Within each stratify; the method of random blocks of 6 will be used to assign participants to two groups A (intervention) and group B (control). For this, the list of blocks is first written and numbers are assigned to them AABB(1)- ABAB(2)-ABBA(3)-BBAA(4) and the order of these blocks will be determined randomly by Excell software, Blinding description: This study will be a single-blinded randomized clinical trial. Therefore, the participants of the study will not be informed from the study groups (intervention-control). For this purpose, sampling of the participants in the intervention and control groups will be done from different centers in the city. The possibility of blinding the researcher is not possible due to the mastery of Rehacom evaluation software. N/A Alzheimer. Intervention 1: "Intervention group" (recipient of cognitive rehabilitation based on Rehacom software): In the intervention group, the rehabilitation program for the intervention group will be implemented individually for 16 sessions of 45 minutes twice a week. Based on the Rehacom platform, the areas of self-awareness, orientation, attention, visual processing, motor vision, motor planning, memory, organization, and problem-solving can be trained. However, each session focuses on the cognitive deficit of different domains. The method of performing each of these tasks will be explained by the researcher for better comprehension of instruction for the elderly. The program of each session will be different from the previous session, which will motivate the subjects to continue the treatment. Intervention 2: "Control group": In the control group, The Rehacom evaluation will be performed before the intervention (at the beginning of the study) and after the intervention period, will be done in the elderly in the control group. These people will carry out their normal life routines and will not receive any rehabilitation intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is Considering that part of the information is related to the elderly with mild Alzheimer's and MCI, the research team prefers that the information is not available to other people except the research team.
public Maryam Chehregosha
Falsafi Educational Campus, Shastkola Road, Hirkan Blvd. Golestan University of Medical Sciences
Gorgan Iran (Islamic Republic of) 4918936316 +98 17 3245 6102 Chehrehgosha@goums.ac.ir Gorgan University of Medical Sciences scientific Maryam Chehrehgosha
Falsafi Educational Campus, Shastkola Road, Hirkan Blvd. Golestan University of Medical Sciences
Gorgan Iran (Islamic Republic of) 4918936316 +98 17 3243 0319 cherehgosha@goums.ac.ir Gorgan University of Medical Sciences Iran (Islamic Republic of) Being older than 65 years Literate person (having at least diploma) Obtaining a score of 11 and greater on the MoCA Obtaining a score of less than 8 on the GDS-15 (Geriatric Depression Scale-15) Ability to speak Persian Having a personal desire to participate in the study Having no epilepsy, vision problems, hearing, or severe disabilities Having aformal or informal caregiver 65 years no limit Both Inability to continue participating for any reason Failure to attend two consecutive or alternating sessions G30.1 Alzheimer's disease with late onset Rehabilitation N/A "Intervention group" (recipient of cognitive rehabilitation based on Rehacom software): In the intervention group, the rehabilitation program for the intervention group will be implemented individually for 16 sessions of 45 minutes twice a week. Based on the Rehacom platform, the areas of self-awareness, orientation, attention, visual processing, motor vision, motor planning, memory, organization, and problem-solving can be trained. However, each session focuses on the cognitive deficit of different domains. The method of performing each of these tasks will be explained by the researcher for better comprehension of instruction for the elderly. The program of each session will be different from the previous session, which will motivate the subjects to continue the treatment. "Control group": In the control group, The Rehacom evaluation will be performed before the intervention (at the beginning of the study) and after the intervention period, will be done in the elderly in the control group. These people will carry out their normal life routines and will not receive any rehabilitation intervention. Processing speed of cognitive tests based on Rehacom. Timepoint: In the intervention group at the beginning of the study, in each treatment session, at the end of the intervention/in the control group at the beginning of the study and at the end of the study. Method of measurement: Rehacom software measures these variables. The difficulty level of the test. Timepoint: In the intervention group at the beginning of the study, in each treatment session, at the end of the intervention/in the control group at the beginning of the study and at the end of the study. Method of measurement: Rehacom software measures these variables. Cognitive status based on MoCA score. Timepoint: In the intervention group at the beginning of the study, in each treatment session, at the end of the intervention/in the control group at the beginning of the study and at the end of the study. Method of measurement: Rehacom software measures these variables. Tabriz University of Medical Sciences Approved 2023-08-28 Ethics committee of Tabriz University of Medical Sciences Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)