Protocol summary

Study aim
The aim of the current research is to study the effect of physical exercise on controlling balance among the visually impaired elderly using auditory vibratory alarming feedback device
Design
This is an experimental and randomized trial that includes aged 65 to 74 years old volunteering volunteers who were living in Mahabad. According to the information on physical and motor health records, 30 were selected, which consisted of two groups of 15 visually impaired people.
Settings and conduct
The Center for Educational Rehabilitation was used in Mahabad, where special mattresses used in taekwondo sport were embedded.The instrument was to detect the interaction of the subjects using a Stabilometer balance device. Subjects were then divided into two groups of 15, who performed balance exercises in 12 sessions.
Participants/Inclusion and exclusion criteria
visually impaired elderly with healthy from the nerve and skeletal aspect.
Intervention groups
A group performed only physical exercises that caused various sensation to be balanced and the other group performed the physical exercises with the use of the biofeedback device.
Main outcome variables
The balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190107042265N1
Registration date: 2019-07-07, 1398/04/16
Registration timing: retrospective

Last update: 2019-07-07, 1398/04/16
Update count: 0
Registration date
2019-07-07, 1398/04/16
Registrant information
Name
Hadi Gevorki
Name of organization / entity
The University of Shahid Beheshty Tehran
Country
Iran (Islamic Republic of)
Phone
+98 44 4222 7439
Email address
hadigevorki@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-04-30, 1397/02/10
Actual recruitment start date
2018-04-30, 1397/02/10
Actual recruitment end date
2018-04-30, 1397/02/10
Trial completion date
2018-07-01, 1397/04/10
Scientific title
The effect of physical exercise on controlling balance among the visually impaired elderly using auditory vibratory alarming feedback device.
Public title
using auditory-vibratory alarming feedback device on balance
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
the visually impaired elderly
Exclusion criteria:
developing neurological disease having a history of a skeletal disiase
Age
From 65 years old to 74 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a randomized random method was used, so that individuals are divided into two groups of physical exercise and physical training group along with the use of biofeedback device.
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 Shahid Beheshti University of Tehran
Street address
Shahid Beheshty University of Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2018-12-01, 1397/09/10
Ethics committee reference number
IR.SBU.ICBS.97/1035

Health conditions studied

1

Description of health condition studied
low vision
ICD-10 code
H54.2
ICD-10 code description
Low vision, both eyes

Primary outcomes

1

Description
Change the score slightly balance
Timepoint
after 6 weeks of training.
Method of measurement
balance measurement device Stabilometer

Secondary outcomes

1

Description
Change the score slightly balance
Timepoint
Before the intervention and 45 days after the start of the training.
Method of measurement
balance test stabilometer device

Intervention groups

1

Description
Intervention group 1: only did the physical training provided by examiner to change the balance score.
Category
Rehabilitation

2

Description
Intervention group: They performed the physical exercise provided by the examiner, and received an equilibrium warning from the feedback device attached to the subjects waist, including vibration and sound through the headphones.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahabad elderly center
Full name of responsible person
Hadi Gevorki
Street address
No.34, Esteghlal Square, 24 meters street to the hospital.
City
Mahabad
Province
West Azarbaijan
Postal code
5916957854
Phone
+98 44 4222 7439
Email
hadigevorki@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The university of shahid Beheshty
Full name of responsible person
Morteza Rezaei Zadeh
Street address
Shahid Chamran highway, Yemen street, Shahid Shahriari Square.
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5305
Fax
+98 21 2243 1919
Email
mortaza_rezaee@yahoo.com
Grant name
Morteza Rezaei Zadeh
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of shahid Beheshty
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Shahid Beheshty
Full name of responsible person
Hadi Gevorki
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
motor behavior
Street address
No.34, Esteghlal Alley , street 24 leters to hospital.
City
Mahabad
Province
West Azarbaijan
Postal code
5916957854
Phone
+98 44 4222 7439
Email
hadigevorki@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Shahid Beheshti Tehran
Full name of responsible person
Hadi Gevorki
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Motor Behavior
Street address
Street 24 Meters to Hospital
City
Mahabad
Province
West Azarbaijan
Postal code
5916957854
Phone
+98 44 4222 7439
Email
hadigevorki@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Hadi Gevorki
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Motor Behavioral (Motor control)
Street address
The University of Shahid Beheshti
City
Tehran
Province
Tehran
Postal code
5916957854
Phone
+98 44 4222 7439
Email
hadigevorki@yahoo.com

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
In the form of an ethical commitment, both participants are assured that their data will be serialized.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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