Protocol summary

Study aim
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
Design
72 elderly people will be entered into the study based on the inclusion criteria. The elderly will be divided into two groups based on their cognitive status and educational status based on random allocation. This study is a single blinded study and the study subjects will not be aware of the study groups. At first, all the elderly will be evaluated using the initial evaluation of Rehacom software. The control group will not receive any program. The elderly in the intervention group will undergo cognitive rehabilitation for 8 weeks, two 45-minute sessions per week with Rehacom software.
Settings and conduct
The statistical population of the study will be the elderly who refer to the daycare centers of Gorgan City. Informed consent will be obtained at the beginning of the research. The primary assessment of the elderly will be done by using the MoCA form and the GDS-15 form. The elderly will be entered into the study if they meet other inclusion criteria.
Participants/Inclusion and exclusion criteria
Being older than 65 years Literate person (having at least a 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 a formal or informal caregiver
Intervention groups
The intervention group will receive the cognitive rehabilitation program. The control group is evaluated only at the beginning and end of the study.
Main outcome variables
The processing speed and the difficulty of the test during 2 months (16 sessions) before and after the intervention in two groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180213038710N2
Registration date: 2023-09-10, 1402/06/19
Registration timing: prospective

Last update: 2023-09-10, 1402/06/19
Update count: 0
Registration date
2023-09-10, 1402/06/19
Registrant information
Name
Maryam Chehrehgosha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0004
Email address
chehrehgosha@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Inability to continue participating for any reason Failure to attend two consecutive or alternating sessions
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2023-08-28, 1402/06/06
Ethics committee reference number
IR.TBZMED.REC.1402.404

Health conditions studied

1

Description of health condition studied
Alzheimer
ICD-10 code
G30.1
ICD-10 code description
Alzheimer's disease with late onset

Primary outcomes

1

Description
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.

2

Description
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.

Secondary outcomes

1

Description
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

Intervention groups

1

Description
"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.
Category
Rehabilitation

2

Description
"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.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Day care centers for the elderly in Gorgan
Full name of responsible person
Maryam Chehrehgoosha
Street address
No 18, Edalat 37Ave, Gorgan, Golestan/No 24, Alley 7,Imam Reza Ave, Sarkhajeh Square, Gorgan, Golestan
City
گرگان
Province
Golestan
Postal code
4917897949
Phone
+98 911 375 5146
Email
chehrehgosha@goums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz shahabi
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 2178
Email
chehrehgosha@goums.ac.ir
Web page address
https://aria.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Maryam Chehregosha
Position
Faculty Member, Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Falsafi Educational Campus, Shastkola Road, Hirkan Blvd. Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3245 6102
Email
Chehrehgosha@goums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Maryam Chehrehgosha
Position
Faculty member/Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Falsafi Educational Campus, Shastkola Road, Hirkan Blvd. Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0319
Email
cherehgosha@goums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Maryam Chehrehgosha
Position
Faculty member/Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Falsafi Educational Campus, Shastkola Road, Hirkan Blvd. Golestan University
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0319
Email
chehrehgosha@goums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
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.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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