Investigating the effect of virtual reality on balance performance and fear of falling among the elderly
Design
A clinical trial with a control group, with parallel groups, assessor blind, randomized, on 30 elderly. A sealed envelope was used for randomization.
Settings and conduct
This study will be performed at the Setaregan-e-Derakhshan Elderly Center. Individuals are randomly divided into two groups of intervention and control, and evaluations are performed by a person who is unaware of randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 60 years; ability to walk independently with or without an assistive device for at least 10 meters; having an acceptable level of cognitive function means a score equal to or higher than 24 in the Mini-Mental State Examination.
Non-inclusion criteria: Suffering from an acute neurological or orthopedic disorder or addiction according to the report of the individual, family, or doctor.
Intervention groups
Control group that receives physical balance exercises. Intervention group that receives balance exercises through the virtual reality system.
Main outcome variables
Balance - Fear of falling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211224053509N1
Registration date:2022-08-16, 1401/05/25
Registration timing:registered_while_recruiting
Last update:2022-08-16, 1401/05/25
Update count:0
Registration date
2022-08-16, 1401/05/25
Registrant information
Name
Moslem Cheraghifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6556 7278
Email address
chraghifard.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2022-12-06, 1401/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of virtual reality and therapeutic exercise on improving balance and fear of falling in Military retirees and elderly
Public title
Effect of virtual reality on balance of elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having an acceptable level of cognitive function, i.e. score equal to or greater than 21 on the Persian version of Mini Mental State Examination
Ability to walk at least 10 meters with or without assistive device
No severe orthopedic or psychological disorders, acute pain, or addictive disorder based on the report fromy the elderly, patient's family, physician, or medical record.
Exclusion criteria:
Having a history of neurological disorders such as stroke, traumatic brain injury, Parkinson, seizures.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the sealed envelope method is used for randomization. Participants are allocated based on a selection of randomly arranged sealed envelopes labeled "virtual reality group" or "exercise therapy group." This process is done by someone who has no role in the data analysis or intervention process.
Blinding (investigator's opinion)
Single blinded
Blinding description
Evaluation of the outcomes is performed by experienced individuals who are blind to the patient's allocation to the groups .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Baqiyatallah Al-Azam Medical Center
Street address
Baqiatallah University of Medical Sciences, Mullasadra Street, Vanak Square,Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2021-12-06, 1400/09/15
Ethics committee reference number
IR.BMSU.BAQ.REC.1400.045
Health conditions studied
1
Description of health condition studied
Older adult- fear of falling
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fear of falling
Timepoint
Before intervention, after intervention and 4 weeks after intervention
Method of measurement
Activities-specific Balance Confidence questionnaire - Fall Efficiency Scale
2
Description
Balance ability
Timepoint
Before intervention, after intervention and 4 weeks after intervention
Method of measurement
Berg Balance scale - time up and go Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (Virtual Reality): The intervention in this group is based on the virtual reality system. The virtual reality system is designed based on force sensors and a motion detector system (Kinect). In performing interventions based on the force sensor, the person stands on the surface in dimensions of 50 x 30 in front of the monitor and performs the activities and games shown on the monitor by changing the center of mass of the body. The activities that a person performs can be leveled and its intensity increases as the person's performance changes. In performing interventions using the Kinect device, the person stands in front of the sensor and performs different motor activities in accordance with the designed activities and games that are displayed on the screen. These motor activities include a variety of activities, such as standing on one leg, jumping, and maintaining balance in a variety of body postures.
Category
Rehabilitation
2
Description
Control group: In the control group, conventional interventions to improve balance are performed according to the Otago Exercise Program (OEP). OEP exercises consist of two parts: strengthening exercises and balance exercises. Strengthening exercises are aimed at increasing the strength of the pelvic floor, knee, and ankle muscles, which will move from an assetive to a resistance one. Balance exercises also include bending the knee, walking backward, walking sideways, standing in a tandem position, random walking, standing on one foot, walking on the toe and heel, sitting and standing up going up and down the stairs
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Setaregan Derakhshan nursing home
Full name of responsible person
Alireza Shamsoddini
Street address
Fadak Educational Complex, After Shahid Sani Khani Clinic, Dr. Abidi St, 8th km of Karaj road, Lashgari highway, Tehran
City
tehran
Province
Tehran
Postal code
13898
Phone
+98 21 4457 0356
Email
setareganderakhshannursinghome@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alireza Shamsoddini
Street address
Baqiyatallah University of Medical Sciences, Mullasadra Street, Vanak Square, Tehran
City
tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
info@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Aliraza Shamsoddini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
BaqiatallahUniversity of Medical Sciences, Mullasadra Street, Vanak Square, Tehran
City
tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
alirezaot@bmsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Aliraza Shamsoddini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
BaqiatallahUniversity of Medical Sciences, Mullasadra Street, Vanak Square, Tehran
City
tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
alirezaot@bmsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Aliraza Shamsoddini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
BaqiatallahUniversity of Medical Sciences, Mullasadra Street, Vanak Square, Tehran
City
tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
alirezaot@bmsu.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
plagiarism
Study Protocol
No - There is not 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