Protocol summary
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Study aim
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The purpose of this study comparison of two proprioception and core stability training programs in the balance and gait kinematics parameters of deaf students
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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- Rehabilitation of the Deaf
- Improve the balance of the deaf
- Improved postural control of the deaf
- Improve the deafness of the deaf
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2017-12-08, 1396/09/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Guilan University of Medical Sciences
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Expected recruitment start date
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2017-12-22, 1396/10/01
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Expected recruitment end date
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2018-02-04, 1396/11/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of two proprioception and core stability training programs in the balance and gait kinematics parameters of deaf students.
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Public title
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The effect of exercise therapy on executive on functions of deaf students
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 15 years old to 18 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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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.
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Subjects were divided into experimental and control groups based on Sealed envelopes.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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.
Ethics committees
1
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Ethics committee
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Approval date
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2017-11-05, 1396/08/14
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Ethics committee reference number
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IR. SSRI. REC. 1396. 146
Health conditions studied
1
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Description of health condition studied
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Balance and gait kinematics parameters
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ICD-10 code
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Z02.5
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ICD-10 code description
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Encounter for examination for participation in sport
Primary outcomes
1
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Description
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Balance
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Timepoint
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Before intervention and 2 months after intervention and 6 months after the post-test.
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Method of measurement
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BESS Test and Y Test
2
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Description
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Postural control
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Timepoint
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Before intervention and 2 months after intervention
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Method of measurement
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SLS Test
3
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Description
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Proprioception
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Timepoint
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Before intervention and 2 months after intervention
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Method of measurement
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Electrogonometer device
4
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Description
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Core stability muscle endurance
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Timepoint
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Before intervention and 2 months after intervention
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Method of measurement
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Core stability test set
5
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Description
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Gait kinematics parameters
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Timepoint
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Before intervention and 2 months after intervention
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Method of measurement
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Digital camera and kinovea software
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Guilan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The total potential data can be shared after unidentifiable people.
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When the data will become available and for how long
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Start the access period 6 months after printing the results.
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To whom data/document is available
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Everyone in the community can use it.
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Under which criteria data/document could be used
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- For deaf rehabilitation fields.
- For trainers and sports science teachers.
- in the field of occupational therapy.
- In sports fields of the disabled.
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From where data/document is obtainable
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Applicants may refer to rehabilitation and sports science journals for receiving data.
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What processes are involved for a request to access data/document
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Extensions can be submitted to the following email address within six months after the results are printed. Email Address: zareei.h@yahoo.com
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Comments
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