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Investigating the effect of perturbation training on balance, function and risk of falling of blind people

Protocol summary

Study aim
This study aimed to investigate the effect of 4-week perturbation-based balance training on risk of falling, movement function and balance in blind people.
Design
This study was a quasi-experimental research with a pretest - post test design with a practice intervention group and a control group. The statistical sample consisted of 24 blind male students of the University of Tehran with a valid age range of 18-30 years, who were selected by targeted sampling.
Settings and conduct
The present study was carried out in the Corrective exercise Laboratory of the University of Tehran. The method of work started with evaluating the balance, motor function and risk of falling of these people and then after the pretest stage, people entered the research and training protocol and were divided into two control and experimental groups. The experimental group also performed perturbation exercises according to the protocol for 4 weeks. After 4 weeks, the research variables were re-evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: male gender, absolute blindness of acquired or congenital type, ability to walk independently, lack of pain and injury in the lower back, no cardiovascular problems, diabetes, no neuropathy and no history of disease. Exclusion criteria: any pain during exercise, no history of participation in a particular sport, no other sensory impairment other than blindness, and students' physical and motor problems.
Intervention groups
An experimental group (12 people): Using a perturbation training protocol, experimental group subjects performed 4 weeks (3 sessions per week) under the supervision of sports researchers and instructors. A control group (12 people): During this time, the control group was allowed to perform their daily activities.
Main outcome variables
Static Balance Dynamic Balance movement Function Risk of falling

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200510047381N1
Registration date: 2020-06-03, 1399/03/14
Registration timing: retrospective

Last update: 2020-06-03, 1399/03/14
Update count: 0
Registration date
2020-06-03, 1399/03/14
Registrant information
Name
Mohammad hani Mansori
Name of organization / entity
The University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 25 3662 2375
Email address
haninio74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-06, 1398/05/15
Expected recruitment end date
2019-10-07, 1398/07/15
Actual recruitment start date
2019-08-06, 1398/05/15
Actual recruitment end date
2019-10-07, 1398/07/15
Trial completion date
2020-02-04, 1398/11/15
Scientific title
Investigating the effect of perturbation training on balance, function and risk of falling of blind people
Public title
the effect of perturbation training on balance of blind people
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Male sex, absolute acquired or congenital blindness The ability to walk independently, no pain or injury in the lower back and lower limbs No cardiovascular problems, diabetes, no neuropathy and No history of illness or medication that affects the nervous system
Exclusion criteria:
Any pain during exercise Lack of a clear track record in sports Having other sensory disorders in addition to blindness Students' physical and mobility problems
Age
From 18 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Actual sample size reached: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization was used to randomly assign subjects to control and experimental groups. Thus, individuals are classified into limited strata based on two influential factors, namely the type of visual impairment (congenital and acquired) and the severity of the disability (absolute and weak), which formed a total of 4 classes. Finally, simple randomization process was performed in each strata. so that each individual from within The sealed envelope was assigned a number, and the subjects were assigned to the experimental group and the control group, if paired.
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 for Tehran University
Street address
No.50, between 15th and 16th St., North Kargar., Faculty of Physical Education and Sport Sciences , University of Tehran
City
Tehran
Province
Tehran
Postal code
1439813117
Approval date
2019-07-15, 1398/04/24
Ethics committee reference number
IR.UT.SPORT.REC.1398.035

Health conditions studied

1

Description of health condition studied
Absolute blindness (acquired and congenital)
ICD-10 code
H53-H54
ICD-10 code description
Visual disturbances, Blindness and low vision

Primary outcomes

1

Description
Static Balance
Timepoint
7 days before the exercise protocol and 4 weeks after exercise
Method of measurement
Modified stork stand balance test for static balance

2

Description
Dynamic Balance
Timepoint
7 days before the exercise protocol and 4 weeks after exercise
Method of measurement
berg balance scale for dynamic balance

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The group that receives the perturbation exercise.
Category
Rehabilitation

2

Description
Control group: A group that did its daily activities.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Laboratory of corrective exercises of the Faculty of Physical Education, University of Tehran
Full name of responsible person
Mohammad hani Mansori
Street address
Amirabad Street between 15th and 17th Alley
City
Tehran
Province
Tehran
Postal code
3718947474
Phone
+98 21 8835 1730
Email
haninio74@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Tehran
Full name of responsible person
Mohammad hani Mansori
Street address
Imam Square, Sistani Complex, Block 2, No. 37
City
Qom
Province
Ghoum
Postal code
3718947474
Phone
+98 25 3662 2375
Email
HANINIO74@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The University of Tehran
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
The University of Tehran
Full name of responsible person
Mohammad hani Mansori
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Physical Education and Sports Science
Street address
Imam Square, Sistani Complex, Block 2, No. 37
City
Qom
Province
Ghoum
Postal code
3718947474
Phone
+98 25 3662 2375
Email
HANINIO74@GMAIL.COM

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Mohammad hani Mansori
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Physical Education and Sports Science
Street address
Imam Square, Sistani Complex, Block 2, No. 37
City
QOM
Province
Ghoum
Postal code
3718947474
Phone
+98 25 3662 2375
Email
HANINIO74@GMAIL.COM

Person responsible for updating data

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Mohammad hani Mansori
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Physical Education and Sports Science
Street address
Imam Square, Sistani Complex, Block 2, No. 37
City
Qom
Province
Ghoum
Postal code
3718947474
Phone
+98 25 3662 2375
Email
HANINIO74@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data on participants' descriptive information as well as pre-test and post-test research variables can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions and the disabled
Under which criteria data/document could be used
If a researcher intends to compare with her(his) research work
From where data/document is obtainable
researcher-haninio74@gmail.com
What processes are involved for a request to access data/document
Apply via email
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