Protocol summary
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Study aim
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the effect of eight weeks of dynamic neuromuscular stability training on a trampoline on motor and respiratory function in individuals with intellectual disability
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Design
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The present study will be conducted as a pre-test-post-test and semi-experimental design with the participation of two groups of dynamic neuromuscular stability exercises on a trampoline and on the ground.
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Settings and conduct
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At the comprehensive career support center and production workshop for the disabled, Pegah Omid, Isfahan (Nemat branch)
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1) Girls with mild to moderate mental retardation with an IQ of 50 to 70 (educable).
2) Written consent from parents or legal guardians to participate during the training and study period.
3) Age range 20 to 30 years.
4) No specific disease or any restriction that prevents participation in the research process.
5) No history of regular participation in exercises similar to the training protocol during the past 6 months.
Exclusion criteria:
1) Non-cooperation and absence during the study for more than 3 consecutive sessions during the entire training period.
2) Occurrence of injury or new medical condition that prevents the individual from continuing the training according to the advice of the physician.
3) Unwillingness of the participant or parent to continue participating in the study at any time.
4) Suffering from heart or respiratory diseases or behavioral problems and any acute or chronic disease.
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Intervention groups
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One group will perform dynamic neuromuscular stability exercises on a trampoline and one group will perform dynamic neuromuscular stability exercises on the ground. These exercises will be performed for 8 weeks, 3 sessions per week, each session lasting approximately 45 minutes.
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Main outcome variables
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Functional Performance and Respiratory Function
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:
IRCT20250721066577N1
Registration date:
2025-07-21, 1404/04/30
Registration timing:
prospective
Last update:
2025-09-16, 1404/06/25
Update count:
1
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Registration date
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2025-07-21, 1404/04/30
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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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Expected recruitment start date
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2025-08-22, 1404/05/31
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Expected recruitment end date
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2025-11-05, 1404/08/14
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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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The Effect of eight Weeks of Dynamic Neuromuscular Stabilization (DNS) exercises on a Trampoline on Functional Performance and Respiratory Function in Individuals with Intellectual Disabilities
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Public title
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The Effect of eight Weeks of Dynamic Neuromuscular Stabilization (DNS) exercises on a Trampoline on Functional Performance and Respiratory Function in Individuals with Intellectual Disabilities
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Purpose
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Other
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Inclusion/Exclusion criteria
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Inclusion criteria:
Girls with mild to moderate mental retardation with an IQ of 50 to 70 (educable)
Written consent from a parent or legal guardian to participate during the training and study period
Age range 20 to 30 years
Absence of any specific disease or any restriction that would prevent participation in the research process
No history of regular participation in exercises similar to the exercise protocol within the past 6 months
Exclusion criteria:
Lack of cooperation and absence during the study for more than 3 consecutive sessions throughout the entire training period
The occurrence of a new injury or medical condition that prevents the individual from continuing to exercise as recommended by their doctor
Unwillingness of the participant or parent to continue participating in the study at any time
Having heart or respiratory diseases or behavioral problems and any acute or chronic illness
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Age
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From 20 years old to 30 years old
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Gender
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Female
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Phase
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N/A
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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
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The samples will be selected purposively and conveniently based on inclusion and exclusion criteria from among mentally retarded girls aged 20 to 30 years at the Pegah Omid Comprehensive Career Support Center and Production Workshop for the Disabled in Isfahan (Nemat Branch). These individuals will be randomly paired and divided into two groups of 15 people.
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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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Other
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Other design features
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After approving the proposal and selecting the subjects on a purposeful and voluntary basis, the participants will be placed into two groups by completing the consent form and based on the inclusion and exclusion criteria. One group will perform dynamic neuromuscular stability exercises on a trampoline and the other group will perform dynamic neuromuscular stability exercises on the ground. These exercises will be performed for 8 weeks, 3 sessions per week, each session lasting approximately 45 minutes. The participants' motor function and respiratory function will be measured before and after the intervention.
Ethics committees
1
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Ethics committee
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Approval date
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2025-07-10, 1404/04/19
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Ethics committee reference number
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1404.090
Health conditions studied
1
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Description of health condition studied
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Intellectual Disabilities
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Functional Performance and Respiratory Function
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Timepoint
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Eight Weeks
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Method of measurement
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Motor Performance: 1) The Time up and go(TUG) test will be used to assess dynamic balance.2)The 4x10 meter back and forth test will be used to assess the lower body agility of these individuals. During this test, the participant moves back and forth along a 10 meter path 4 times as quickly as possible upon hearing the start command, and after reaching the line each time, crosses it and changes direction. 3)The Sargent Jump Test will be used to measure explosive power of the lower body muscles. The maximum distance the participant can jump upwards will be recorded as an indicator of explosive power of the lower body muscles. 4)To assess visual-motor coordination, a toss and catch test will be used. During this test, the participant throws and catches a ball against a wall. The number of successful catches will be recorded in a specified time. 5)The Ruler Drop Test will be used to assess reaction speed. The ruler is dropped from a specified height and the participant must catch it as quickly as possible. The distance traveled before catching the ruler will be recorded as an indicator of reaction time. Respiratory function: A spirometer will be used to assess respiratory function. This device is capable of measuring parameters such as forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC ratio. The spirometry test will be performed by a trained operator following standard guidelines.
Intervention groups
1
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Description
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Intervention group: The present study will be conducted as a pre-test-post-test and semi-experimental study with the participation of two groups of dynamic neuromuscular stability exercises on a trampoline and on the ground.
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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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The University of Isfahan
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Proportion provided by this source
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50
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All data is potentially shareable after de-identifying individuals.
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When the data will become available and for how long
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Access period starts 6 months after results are published.
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To whom data/document is available
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My data will only be available to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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There is no further information
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From where data/document is obtainable
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To receive data/documents, please contact Ms. Maryam Valikhani at 09338178219 and address: Isfahan, Hezar Jerib, University of Isfahan.
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What processes are involved for a request to access data/document
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There is no further information
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Comments
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