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Protocol summary
- توانبخشی ناشنوایان
- بهبود تعادل ناشنوایان
- بهبود کنترل پاسچر ناشنوایان
- بهبود راه رفتن ناشنوایان
- توانبخشی ناشنوایان
- تعادل ناشنوایان
- کنترل پاسچر ناشنوایان
- راه رفتن ناشنوایان
- توانبخشی ناشنوایان - بهبود تعادل ناشنوایان - بهبود کنترل پاسچر ناشنوایان - بهبود راه رفتن ناشنوایان
General information
EBD
EBD
Primary outcomes
#1
Before intervention and 2 months after intervention
Before intervention and 2 months after intervention and 6 months after the post-test.
Before intervention and 2 months after intervention and 6 months after the post-test.
قبل از مداخله و 2 ماه بعد از مداخله
قبل از مداخله ، 2 ماه بعد از مداخله و 6 ماه بعد از پس آزمون
قبل از مداخله و، 2 ماه بعد از مداخله و 6 ماه بعد از پس آزمون
Secondary outcomes
#1
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empty
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empty
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empty
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empty
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empty
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empty
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Recruitment centers
#1
Name of recruitment center - English: Baghcheban Deaf School
Name of recruitment center - Persian: مدرسه ناشنوایان باغچه بان
Full name of responsible person - English: Hamed Zarei
Full name of responsible person - Persian: حامد زارعی
Street address - English: Tarbiat Moallem University side , Tarbiat Moallem Square, Guilan Blvd Rasht city
Street address - Persian: شهر رشت، بلوار گیلان، میدان تربیت معلم، جنب دانشگاه تربیت معلم
City - English: Rasht
City - Persian: رشت
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Baghcheban Deaf School
Name of recruitment center - Persian: مدرسه ناشنوایان باغچه بان
Full name of responsible person - English: Hamed Zarei
Full name of responsible person - Persian: حامد زارعی
Street address - English: Tarbiat Moallem University side , Tarbiat Moallem Square, Guilan Blvd Rasht city
Street address - Persian: شهر رشت، بلوار گیلان، میدان تربیت معلم، جنب دانشگاه تربیت معلم
City - English: Rasht
City - Persian: رشت
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 4136718838
Phone:
Fax:
Email: zareei.h@yahoo.com
Web page address:
Name of recruitment center - English: Baghcheban Deaf School Name of recruitment center - Persian: مدرسه ناشنوایان باغچه بان Full name of responsible person - English: Hamed Zarei Full name of responsible person - Persian: حامد زارعی Street address - English: Tarbiat Moallem University side , Tarbiat Moallem Square, Guilan Blvd Rasht city Street address - Persian: شهر رشت، بلوار گیلان، میدان تربیت معلم، جنب دانشگاه تربیت معلم City - English: Rasht City - Persian: رشت Province: Guilan Country: Iran (Islamic Republic of) Postal code: 4136718838 Phone: Fax: Email: zareei.h@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: University of Medical Sciences Guilan
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی گیلان
Full name of responsible person - English: Seyyed Ziaeddin Mirhosseini
Full name of responsible person - Persian: سید ضیاء الدین میرحسینی
Street address - English: Faculty of Physical Education, University of Guilan, Km 12 Rasht-Ghazvin Road
Street address - Persian: کیلومتر 12 جاده رشت-قزوین، دانشکده تربیت بدنی، دانشگاه گیلان.
City - English: Rasht
City - Persian: رشت
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Guilan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی گیلان
Full name of responsible person - English: Seyyed Ziaeddin Mirhosseini
Full name of responsible person - Persian: سید ضیاء الدین میرحسینی
Street address - English: Faculty of Physical Education, University of Guilan, Km 12 Rasht-Ghazvin Road
Street address - Persian: کیلومتر 12 جاده رشت-قزوین، دانشکده تربیت بدنی، دانشگاه گیلان.
City - English: Rasht
City - Persian: رشت
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 4199613776
Phone: +98 13 3369 0274
Fax:
Email: zareei.h@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Guilan University of Medical Sciences Guilan Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی گیلان Full name of responsible person - English: Seyyed Ziaeddin Mirhosseini Full name of responsible person - Persian: سید ضیاء الدین میرحسینی Street address - English: Faculty of Physical Education, University of Guilan, Km 12 Rasht-Ghazvin Road Street address - Persian: کیلومتر 12 جاده رشت-قزوین، دانشکده تربیت بدنی، دانشگاه گیلان. City - English: Rasht City - Persian: رشت Province: Guilan Country: Iran (Islamic Republic of) Postal code: 4199613776 Phone: +98 13 3369 0274 Fax: Email: zareei.h@yahoo.com Web page address:
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Yes
1
Protocol summary
Study aim
The purpose of this study comparison of two proprioception and core stability training programs in the balance and gait kinematics parameters of deaf students
Design
In this study, 30 students who are deaf and criteria of the study, the deaf school in Rasht city elected. The participants were randomly divided into two groups: proprioception (10-person) and core stability (10 members) and a control group (10 people) is divided and each participant is assigned a code.
Settings and conduct
The current study is of clinical trial one aiming to Comparison of two proprioception and core stability training programs in the balance and gait kinematics parameters of deaf students. It will be used the BESS test for static balance, the SLS test for control posture, the Y test (YBT) for dynamic balance, an electrogonimetric device for the proprioception of joints, and a core stability muscle endurance test set; and it will be used to evaluate the gait kinematic parameters from digital cameras and then using Kinava software.
Participants/Inclusion and exclusion criteria
The inclusion criteria: age of 15-18; hearing range of more than 75 db and avoidance of medicines that affect balance during research procedure. The exclusion criteria: avoidance of participating in the relevant sessions and not completing the length of training period; cardiovascular and respiratory disease
Intervention groups
The first experimental group has performed proprioception training (without visual activity), the second experimental group has performed core stabilization training for 8 weeks and the control group did not receive any exercise programs.
Main outcome variables
- Rehabilitation of the Deaf
- Improve the balance of the deaf
- Improved postural control of the deaf
- Improve the deafness of the deaf
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170312033029N2
Registration date:2017-12-08, 1396/09/17
Registration timing:prospective
Last update:2018-04-03, 1397/01/14
Update count:1
Registration date
2017-12-08, 1396/09/17
Registrant information
Name
Hamed Zarei
Name of organization / entity
University of Guilan
Country
Iran (Islamic Republic of)
Phone
+98 81 3536 3540
Email address
zareei.hamed71@gmail.com
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-02-04, 1396/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two proprioception and core stability training programs in the balance and gait kinematics parameters of deaf students.
Public title
The effect of exercise therapy on executive on functions of deaf students
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The inclination of participation in the research
The refraining of tranquilizers or those with effects on balance
The Lack of cochlear implantation
The hearing range of more than 75 db.
Avoidance of exercising or any intense activities during the research
No lower limb damage background during the past 6 months or any neural or muscular complexities
No eyesight disorder
Lack of any status abnormalities effective in the procedure of the research (in the lower and upper limbs)
Not surgical background in the past year
Not a fracture in the upper and lower limbs a year prior to research
Non-insulin-dependent diabetes
Boys subjects
Exclusion criteria:
Lack of participation in two sequential practice sessions or in three interrupted practice sessions
The advent of Musculoskeletal pain after practice
Students suffering from multiple disabilities
Students cardiovascular and respiratory diseases
Students articular system and orthopedic disorders including neck pain, backache, rheumatoid arthritis or the apparent difference in the length of the limbs
Age
From 15 years old to 18 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
1
In each person, the tests of balance, postural control and kinematic walking parameters are measured.
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were divided into experimental and control groups based on Sealed envelopes.
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
Institute of Physical Education and Sport Sciences
Encounter for examination for participation in sport
Primary outcomes
1
Description
Balance
Timepoint
Before intervention and 2 months after intervention and 6 months after the post-test.
Method of measurement
BESS Test and Y Test
2
Description
Postural control
Timepoint
Before intervention and 2 months after intervention
Method of measurement
SLS Test
3
Description
Proprioception
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Electrogonometer device
4
Description
Core stability muscle endurance
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Core stability test set
5
Description
Gait kinematics parameters
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Digital camera and kinovea software
Secondary outcomes
empty
Intervention groups
1
Description
The proprioception training group will attend training sessions for 8 weeks (Every week three sessions and each session for 60 minutes) and their status will be evaluated before and two months after the intervention.
Category
Rehabilitation
2
Description
The core stability training group will attend training sessions for 8 weeks (Every week three sessions and each session for 60 minutes) and their status will be evaluated before and two months after the intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghcheban Deaf School
Full name of responsible person
Hamed Zarei
Street address
Tarbiat Moallem University side , Tarbiat Moallem Square, Guilan Blvd Rasht city
City
Rasht
Province
Guilan
Postal code
4136718838
Email
zareei.h@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
Seyyed Ziaeddin Mirhosseini
Street address
Faculty of Physical Education, University of Guilan, Km 12 Rasht-Ghazvin Road
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0274
Email
zareei.h@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Guilan 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
University of Guilan
Full name of responsible person
Hamed Zarei
Position
Postgradute
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Physical Education, University of Guilan, Km 12 Rasht-Ghazvin Road
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 81 3536 3540
Fax
Email
zareei.h@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Guilan
Full name of responsible person
Hamed Zarei
Position
Postgraduate
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Physical Education, University of Guilan, Km 12 Rasht-Ghazvin Road
City
Rasht
Province
Guilan
Postal code
6557197411
Phone
+98 81 3536 3540
Fax
Email
zareei.h@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Guilan
Full name of responsible person
Hamed Zarei
Position
Postgraduate
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Physical Educations, University of Guilan, Km 12 Rasht-Ghazvin Road
City
Rasht
Province
Guilan
Postal code
4199843653
Phone
+98 81 3536 3540
Fax
Email
zareei.h@yahoo.com
Web page address
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people.
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
Everyone in the community can use it.
Under which criteria data/document could be used
- For deaf rehabilitation fields.
- For trainers and sports science teachers.
- in the field of occupational therapy.
- In sports fields of the disabled.
From where data/document is obtainable
Applicants may refer to rehabilitation and sports science journals for receiving data.
What processes are involved for a request to access data/document
Extensions can be submitted to the following email address within six months after the results are printed. Email Address: zareei.h@yahoo.com