Protocol summary

Study aim
Design, implementation, and validation of a virtual reality package based on dual tasks including navigation and shopping scenarios from a virtual store based on 360-degree images to improve the cognitive and motor components of the elderly
Design
Single-Blinded Study with Block-Randomized Technique
Settings and conduct
Kahrizak Charitable Hospital
Participants/Inclusion and exclusion criteria
Having the Age of 60 Years and above and Physical Ability to Stand and Walk and Regular Physical Activity
Intervention groups
A Control Group with 15 Members, an Intervention Group treadmill with 15 Members (Motor), an Intervention Group Virtual Reality with 15 Members (Cognitive), and an Intervention Group Treadmill and Virtual Reality with 15 Members(Motor and Cognitive)
Main outcome variables
Balance, Attention, Memory, and Visual-Spatial Perception

General information

Reason for update
Acronym
VRS360
IRCT registration information
IRCT registration number: IRCT20231229060567N1
Registration date: 2024-02-07, 1402/11/18
Registration timing: registered_while_recruiting

Last update: 2024-02-07, 1402/11/18
Update count: 0
Registration date
2024-02-07, 1402/11/18
Registrant information
Name
Mohsen Mohammadvaliee
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3793 2127
Email address
momova@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-30, 1402/11/10
Expected recruitment end date
2024-05-04, 1403/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, Implementation, and Validation of a Virtual Reality Package based on 360-Degree Videos with Dual-Task Training for Enhancing Motor-Cognitive Functions in the Elderly
Public title
Motor and Cognitive Empowerment of the Elderly Using Dual-Task Training
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having an old age of 60 Years Or Older According to the Definition of the World Health Organization Normal Eyesight and Hearing None Serious Psychiatric, Cognitive and Psychological Disorders None Simultaneous Cognitive Interventions Being able to Stand, Walk, and Do Usual Physical Activity None Medical Prohibition for Physical Activities Weight Less Than 110 Kg Due to Prevent Damage to the Treadmill Platform Signing the Consent Form to Participate in the Research None Bone Lesion (Decentralized Fractures, Unstable Spine or Severe Osteoporosis)
Exclusion criteria:
Need Help During Intervention Having Uncontrolled Blood Pressure Greater than 100/160 mmHg Lack of Ability to Follow Orders Several Falls During Intervention Not Being Able to Carry out Interventions Independently Physical Problems Occurrence During the Implementation of Interventions Simultaneous Concurrent Cognitive or Psychiatric Interventions Absence in more than One-Third of Intervention Sessions Cardio-Pulmonary Disorders Affecting Movement or Having Bone Lesions
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block method is used for random allocation in such a way that a statistician designs blocks of four into four equal groups, using "sealedenvelope.com". A person not involved in the research, block and allocate sequence for concealment. The allocation ratio of the samples is 1:1. Finally, based on the obtained blocks and according to the sequence of allocation, dual-task rehabilitation training is presented to the participants.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are randomly divided into four groups. These groups are the control group, the treadmill rehabilitation, the virtual reality rehabilitation, and the dual rehabilitation of treadmill and virtual reality. They are unaware of the allocation of study groups and the type of rehabilitation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics committees of University of Isfahan
Street address
Dept. 2, No.2, Sabzi Alley, Karimshahian St., Pirouzi Ave.
City
Tehran
Province
Tehran
Postal code
1766744958
Approval date
2023-12-23, 1402/10/02
Ethics committee reference number
IR.UI.REC.1402.129

Health conditions studied

1

Description of health condition studied
Empowering Healthy Elderly
ICD-10 code
Z76.3
ICD-10 code description
Healthy person accompanying sick person

Primary outcomes

1

Description
Balance
Timepoint
One Day before the Start of the Intervention Sessions and One Day after the End of the Intervention Sessions
Method of measurement
Berg Balance Scale (BBS), Timed Up and Go Test (TUG), and Functional Reach Test (FRT)

2

Description
Attention
Timepoint
One Day before the Start of the Intervention Sessions and One Day after the End of the Intervention Sessions
Method of measurement
Mini–Mental State Examination (MMSE) and Continuous Performance Test (CPT)

3

Description
Memory
Timepoint
One Day before the Start of the Intervention Sessions and One Day after the End of the Intervention Sessions
Method of measurement
Mini–Mental State Examination (MMSE) and N-Back Working Memory Test

4

Description
Visual-Spatial Perception
Timepoint
One Day before the Start of the Intervention Sessions and One Day after the End of the Intervention Sessions
Method of measurement
Mini–Mental State Examination (MMSE), Hooper Visual Organization Test (HVOT), and Judgment of Line Orientation (JLO)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: 15 Healthy Elderly People
Category
N/A

2

Description
Intervention group: 15 Healthy Elderly People only Treadmill (Motor)
Category
Rehabilitation

3

Description
Intervention group: 15 Healthy Elderly People only Virtual Reality (Cognitive)
Category
Rehabilitation

4

Description
Intervention group: 15 Healthy Elderly People Treadmill and Virtual Reality (Motor and Cognitive)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Kahrizak Charitable Hospital
Full name of responsible person
Dr. Hossein Nahvi Nejad
Street address
Dr. Hakimzadeh Blvd., Old Qom Road,
City
Tehran
Province
Tehran
Postal code
1819117536
Phone
+98 21 5652 5804
Fax
+98 21 5652 3122
Email
kcf@kahrizak.com
Web page address
https://kahrizakcharity.com/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Esfahan
Full name of responsible person
Dr. Javad Rasti
Street address
Daneshgah Ave., Azadi Sq.
City
Tehran
Province
Tehran
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2128
Email
research.deputy@dean.ui.ac.ir
Web page address
https://www.ui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Esfahan
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
University of Isfahan
Full name of responsible person
Mohsen Mohammadvaliee
Position
Student
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
University of Isfahan, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2127
Fax
Email
momova@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Dr. Javad Rasti
Position
Committee of Science
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
University of Isfahan, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۴۱۸۱۷۴۶
Phone
+98 31 3793 4034
Fax
Email
rasti@eng.ui.ac.ir
Web page address
https://jrasti.ir/

Person responsible for updating data

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Mohsen Mohammadvaliee
Position
Student
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
University of Isfahan, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2127
Fax
Email
momova@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Total Results of Scores of Intervention Sessions, Pre-Intervention and Post-Intervention Tests
When the data will become available and for how long
One Year after the Publishing of Results
To whom data/document is available
Researchers Working in Academic and Scientific Institutions
Under which criteria data/document could be used
Data Analysis and Comparison
From where data/document is obtainable
Email Address
What processes are involved for a request to access data/document
Sending Email and Authentication
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