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Comparison of three Conventional, Virtual Reality and Artificial intelligence balance training programs on balance and gait of elderly people

Protocol summary

Study aim
This study will be conducted with the aim of Comparison of three Conventional, Virtual Reality and Artificial intelligence balance training programs on balance and gait of elderly people.
Design
The present study is a stratified trial (male and female), with equal randomization (one-to-one ratio), in parallel, and includes a pretest/posttest design with a two-month follow-up that will be conducted on 48 elderly residents of a nursing home. Participants will be randomly divided into three groups: artificial intelligence exercises (n=16), virtual reality (n=16), and Conventional balance exercises (n=16).
Settings and conduct
The exercises in the intervention groups are performed for 8 weeks, 3 sessions per week for one hour, every other day. To assess the balance and gait of the subjects, balance indices (standing balance test, single-leg standing, rise and go time, functional reach, activity-specific balance confidence scale) and gait indices (gait speed, gait cadence, and gait stability ratio) are used.
Participants/Inclusion and exclusion criteria
Inclusion criteria included: 1- Obtaining informed consent from the elderly to participate in the study 2- Age range between 60-75 years 3- Mini-Mental State Examination (MMSE) score of 24 or higher 4- Ability to walk independently for at least 6 meters without using an assistive device and exclusion criteria included: 1- Having a serious visual or hearing impairment 2- Participants with significant cognitive impairment 3- Participants with unstable medical conditions (such as recent myocardial infarction, uncontrolled diabetes, fractures in the lower extremities) in the past 6 months.
Intervention groups
Intervention groups: artificial intelligence, virtual reality, and Conventional balance exercises
Main outcome variables
Balance situation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181113041645N2
Registration date: 2025-04-18, 1404/01/29
Registration timing: prospective

Last update: 2025-04-18, 1404/01/29
Update count: 0
Registration date
2025-04-18, 1404/01/29
Registrant information
Name
Saaed Yousefi Babadi
Name of organization / entity
The University of Guilan
Country
Iran (Islamic Republic of)
Phone
+98 38 3362 7153
Email address
saeed.yoosefi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-20, 1404/01/31
Expected recruitment end date
2025-06-24, 1404/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three Conventional, Virtual Reality and Artificial intelligence balance training programs on balance and gait of elderly people
Public title
The effect of artificial intelligence exercises on the balance of the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Receiving the consent of the elderly to participate in the study The age range between 60-75 years Mini-Mental State Examination (MMSE) score of 24 or higher Ability to walk independently for at least 6 meters without using an assistive device
Exclusion criteria:
Serious visual or hearing impairment Participants with significant cognitive impairment Participants with unstable medical conditions (such as recent myocardial infarction, uncontrolled diabetes, fractures in the lower extremities) in the past 6 months
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: 48
Randomization (investigator's opinion)
Not randomized
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
University of Guilan (Research Ethics Committee)
Street address
5th Kilometer of Persian Gulf Highway, Rasht, Guilan Province, Iran
City
Rasht
Province
Guilan
Postal code
۴۱۹۹۶۱۳۷۷۶
Approval date
2024-12-29, 1403/10/09
Ethics committee reference number
IR.GUILAN.REC.1403.182

Health conditions studied

1

Description of health condition studied
balance
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Balance is the ability to maintain the body’s center of mass over its base of support.
Timepoint
One week before and after carrying out training interventions
Method of measurement
Balance indices (standing balance test, single-leg standing test, stand-to-walk test, functional reach test, and activity-specific balance confidence scale) are used to assess the subjects' balance.

2

Description
Gait indices refer to a set of parameters used to evaluate an individual's gait pattern and performance.
Timepoint
One week before and after carrying out training interventions
Method of measurement
Gait tests (gait speed, gait cadence, and gait stability ratio) are used to evaluate gait indices.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Balance training with virtual reality (VR) has been proposed as an alternative to traditional balance training, where the technology simulates activity to promote motor learning and transfer to real-world tasks. (The VR training group) conducted training sessions using an Xbox Kinect, which includes a Kinect sensor and console. The sensor was an infrared camera that detected the player's position and movements without the need for a special controller, and with it the subject controlled various games.
Category
Rehabilitation

2

Description
Intervention group: The AI ​​training program used an AI conversational platform to deliver balance and gait exercises. The program consisted of a series of interactive conversations between subjects and an AI trainer, with exercises tailored to the needs and goals of the participants. The conversations instructed the AI ​​platform to design an 8-week exercise program for healthy individuals aged 60 to 75 to improve their physical performance based on the principles of exercise prescription for the elderly.
Category
Rehabilitation

3

Description
Intervention group: Conventional balance exercises include exercises with reduced support, closing the eyes, increasing movement speed, and adding appropriate movements.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Golden years
Full name of responsible person
Mohammad Ali Alian
Street address
No. 46, Keshavarz Alley, Valiasr Blvd Rasht, Gilan
City
Rasht
Province
Guilan
Postal code
4169685349
Phone
+98 13 3375 5832
Email
azitajfallah@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Guilan
Full name of responsible person
Mansoureh Jahantab
Street address
Persian Gulf Highway (5 km on Qazvin Road) Rasht, Gilan
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0258
Email
saeed.yoosefi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Guilan
Proportion provided by this source
5
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 Guilan
Full name of responsible person
Saaed Yousefi Babadi
Position
PhD student in Sport Injuries & Corrective Exercises, Faculty of Physical Education and Sport Scienc
Latest degree
Master
Other areas of specialty/work
Geriatrics
Street address
Persian Gulf Highway (5 km on Qazvin Road) Rasht, Gilan
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 910 742 6773
Email
saeed.yoosefi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University
Full name of responsible person
Saeed Yousefi Babadi
Position
PhD student in Sport Injuries & Corrective Exercises, Faculty of Physical Education and Sport Scienc
Latest degree
Master
Other areas of specialty/work
Geriatrics
Street address
Persian Gulf Highway (5 km on Qazvin Road) Rasht, Gilan
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 910 742 6773
Email
saeed.yoosefi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Guilan University
Full name of responsible person
Saeed Yousefi Babadi
Position
PhD student in Sport Injuries & Corrective Exercises, Faculty of Physical Education and Sport Scienc
Latest degree
Master
Other areas of specialty/work
Geriatrics
Street address
Persian Gulf Highway (5 km on Qazvin Road) Rasht, Gilan
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 910 742 6773
Email
saeed.yoosefi@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The only part of the information, such as information on the main outcomes or the like, can be shared.
When the data will become available and for how long
Start the access period 6 month after the publication of the research results in a scientific journal
To whom data/document is available
Data will be available to all scientific researchers
Under which criteria data/document could be used
Only to help scientific research and with the written permission of the researcher can be used
From where data/document is obtainable
To receive data/document via email and phone, contact the researcher
What processes are involved for a request to access data/document
Data/document is provided by email to other investigators
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