The effectiveness of perceptual-motor exercises based on multiple sensory therapies in the elderly with cognitive impairments
Design
The statistical population includes all elderly people who are referred to the daily and outpatient welfare centers of Semnan based on incoming criteria. The sampling method will be available from the type of samples that will be unrandomly assigned to the test and control groups.
Settings and conduct
The place of study will be at the Semnan elderly day care center. The treatment program will be run in 12 sessions 3 days a week.
Participants/Inclusion and exclusion criteria
Inclusion criteria included age between 61-70 years, the elderly with mild cognitive impairment with an MMSE score between 21 and 24, and exclusion criteria including hearing and vision impairment, other sensory disorders, lack of cooperation of the elderly in treatment sessions, and evaluations before and after treatment intervention.
Intervention groups
Before starting treatment sessions, participants in a session are measured individually using study tools. Therapeutic interventions are then performed for the experimental group (integration of multiple sensory approach with perceptual-motor exercises). The control group receives routine occupational therapy treatments.
Main outcome variables
Montreal Cognitive Questionnaire, Wisconsin Card Matching Test, Body Image Questionnaire, Lipad Quality of Life Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171219037954N4
Registration date:2022-01-06, 1400/10/16
Registration timing:prospective
Last update:2022-01-06, 1400/10/16
Update count:0
Registration date
2022-01-06, 1400/10/16
Registrant information
Name
Minasadat Mirshoja
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
msj5831@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of perceptual-motor exercises based on multiple sensory therapy in the elderly with cognitive impairments
Public title
Perceptual-motor exercises and multiple sensory therapy in the elderly with cognitive impairments
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 61-70 years
Elderly people with mild cognitive impairment with an MMSE score between 21 and 24
Exclusion criteria:
Existence of hearing and vision impairment
Having other sensory disturbances that adversely affect interaction with objects and the environment
Other psychiatric disorders, such as major depression, schizophrenia, dementia with doctor approval, and Beck Depression and Anxiety Tests
Lack of elderly participation in treatment sessions and evaluations before and after treatment intervention
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Semnan University of Medical science
Street address
Semnan, Basij Boulevard, the headquarters of Semnan University of Medical Sciences
City
semnan
Province
Semnan
Postal code
3514799442
Approval date
2021-12-29, 1400/10/08
Ethics committee reference number
IR.SEMUMS.REC.1400.237
Health conditions studied
1
Description of health condition studied
Dementia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Level of Cognitive
Timepoint
Before and after treatment sessions
Method of measurement
Montreal Cognitive Questionnaire, abbreviated cognitive test, Wisconsin card matching test
2
Description
Quality of Life Questionnaire
Timepoint
Before and after treatment sessions
Method of measurement
Lipad Quality of Life Questionnaire
3
Description
Physical perception
Timepoint
Before and after treatment sessions
Method of measurement
Body image questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before the start of the treatment sessions, participants in one session are assessed individually using the Montreal Cognitive Questionnaire, Wisconsin Card Matching Test, Body Image Questionnaire, and Lipad Quality of Life Questionnaire. Therapeutic interventions for the experimental group (integration of multiple sensory approach with perceptual-motor exercises) are then performed for 12 sessions 3 days a week for 45 to 60 minutes.
Category
Rehabilitation
2
Description
Control group: Before the start of the treatment sessions, participants in one session are assessed individually using the Montreal Cognitive Questionnaire, Wisconsin Card Matching Test, Body Image Questionnaire, and Lipad Quality of Life Questionnaire. The control group received routine occupational therapy treatments for 12 sessions 3 days a week for 45 to 60 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Centers for Health of the Elderly of Semnan City
Full name of responsible person
mina sadat mirshoja
Street address
Semnan, Basij Boulevard, the headquarters of Semnan University of Medical Sciences
City
سمنان
Province
Semnan
Postal code
3514799442
Phone
+98 23 6533 8041
Email
msj5831@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Majid Mir Mohammadkhani
Street address
Semnan, Basij Boulevard, the headquarters of Semnan University of Medical Sciences
City
semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 6533 8041
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
mina sadat mirshoja
Position
Academic Member
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Semnan, Basij Boulevard, the headquarters of Semnan University of Medical Sciences
City
سمنان
Province
Semnan
Postal code
3514799442
Phone
+98 23 6533 8041
Email
msj5831@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
mina sadat mirshoja
Position
Academic member
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Semnan, Basij Boulevard, the headquarters of Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 6533 8041
Email
msj5831@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
mina sadat mirshoja
Position
Academic member
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Semnan, Basij Boulevard, the headquarters of Semnan University of Medical Sciences
City
semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 6533 8041
Email
msj5831@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Reproductive in the field of rehabilitation and behavioral science
When the data will become available and for how long
1years
To whom data/document is available
Researcher
Under which criteria data/document could be used
En Reproductive in the field of rehabilitation and behavioral science
From where data/document is obtainable
Semnan University of Medical Sciences
What processes are involved for a request to access data/document
Supervision of the Student Research Committee of Semnan University of Medical Sciences - fulfillment of main investigator's obligations