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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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History
# Registration date Revision Id
2 2025-09-14, 1404/06/23 355264
1 2025-07-21, 1404/04/30 348408
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  • Primary outcomes

    #1
    Motor Performance: 1) The Y-Balance Test will be used to assess dynamic balance. In this test, the participant, while standing on one leg, will reach the greatest possible distance in three directions with the free leg without losing balance. The average of the greatest distances recorded in these three directions is considered as an index of 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.
    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.
    عملکرد حرکتی:1)برای ارزیابی تعادل پویا از تست وای (Y-Balance Test) استفاده خواهد شد.در این آزمون شرکت کننده در حالی که روی یک پا ایستاده است، با پای آزاد در سه جهت به بیشترین فاصله ممکن بدون اینکه تعادل خود را از دست بدهد دست خواهد یافت. میانگین بیشترین فاصله های ثبت شده در این سه جهت به عنوان شاخص تعادل پویا در نظر گرفته میشود.2)برای ارزیابی چابکی پایین تنه این افراد از آزمون رفت و برگشت 4×10 متر استفاده خواهد شد.طی این آزمون شرکت کننده مسیر 10 متری را 4 بار به صورت رفت و برگشت در سریع ترین زمان ممکن با شنیدن فرمان شروع حرکت کرده و پس از هربار رسیدن به خط، از آن عبور کرده و تغییر جهت میدهد.3)برای سنجش قدرت انفجاری عضلات پایین تنه از آزمون پرش عمودی سارجنت(Sargent Jump Test) استفاده خواهد شد. بیشترین مسافت ممکن که شرکت کننده به سمت بالا،به عنوان شاخصی از قدرت انفجاری عضلات پایین تنه ثبت خواهد شد.4)برای ارزیابی هماهنگی بینایی-حرکتی از آزمون پرتاب و دریافت توپ (Toss & catch) استفاده خواهد شد.طی این آزمون شرکت کننده توپ را به دیوار پرتاب کرده و دریافت میکند.تعداد دریافت های موفق در زمان مشخص ثبت خواهند شد.5) برای ارزیابی سرعت واکنش از آزمون افتادن خط کش (Ruler Drop Test) استفاده خواهد شد.خط کش از ارتفاع مشخص رها میشود و شرکت کننده باید در سریع ترین زمان ممکن آن را بگیرد.مسافت طی شده قبل از گرفتن خط کش به عنوان شاخص زمان واکنش ثبت خواهد شد. عملکرد تنفسی:برای ارزیابی عملکرد تنفسی، از دستگاه اسپیرومتر (Spirometer) استفاده خواهد شد. این دستگاه قادر است پارامترهایی مانند حجم بازدم اجباری در یک ثانیه(FEV1)، ظرفیت حیاتی اجباری (FVC) و نسبت FEV1/FVC را اندازه‌گیری کند.آزمون اسپیرومتری با رعایت دستورالعمل‌های استاندارد و توسط اپراتور آموزش‌دیده انجام خواهد شد.
    عملکرد حرکتی:1)برای ارزیابی تعادل پویا از ازمون زمان دار برخواستن و برگشتن (TUG) استفاده خواهد شد.2)برای ارزیابی چابکی پایین تنه این افراد از آزمون رفت و برگشت 4×10 متر استفاده خواهد شد.طی این آزمون شرکت کننده مسیر 10 متری را 4 بار به صورت رفت و برگشت در سریع ترین زمان ممکن با شنیدن فرمان شروع حرکت کرده و پس از هربار رسیدن به خط، از آن عبور کرده و تغییر جهت میدهد.3)برای سنجش قدرت انفجاری عضلات پایین تنه از آزمون پرش عمودی سارجنت(Sargent Jump Test) استفاده خواهد شد. بیشترین مسافت ممکن که شرکت کننده به سمت بالا،به عنوان شاخصی از قدرت انفجاری عضلات پایین تنه ثبت خواهد شد.4)برای ارزیابی هماهنگی بینایی-حرکتی از آزمون پرتاب و دریافت توپ (Toss & catch) استفاده خواهد شد.طی این آزمون شرکت کننده توپ را به دیوار پرتاب کرده و دریافت میکند.تعداد دریافت های موفق در زمان مشخص ثبت خواهند شد.5) برای ارزیابی سرعت واکنش از آزمون افتادن خط کش (Ruler Drop Test) استفاده خواهد شد.خط کش از ارتفاع مشخص رها میشود و شرکت کننده باید در سریع ترین زمان ممکن آن را بگیرد.مسافت طی شده قبل از گرفتن خط کش به عنوان شاخص زمان واکنش ثبت خواهد شد. عملکرد تنفسی:برای ارزیابی عملکرد تنفسی، از دستگاه اسپیرومتر (Spirometer) استفاده خواهد شد. این دستگاه قادر است پارامترهایی مانند حجم بازدم اجباری در یک ثانیه(FEV1)، ظرفیت حیاتی اجباری (FVC) و نسبت FEV1/FVC را اندازه‌گیری کند.آزمون اسپیرومتری با رعایت دستورالعمل‌های استاندارد و توسط اپراتور آموزش‌دیده انجام خواهد شد.

Protocol summary

Study aim
the effect of eight weeks of dynamic neuromuscular stability training on a trampoline on motor and respiratory function in individuals with intellectual disability
Design
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.
Settings and conduct
At the comprehensive career support center and production workshop for the disabled, Pegah Omid, Isfahan (Nemat branch)
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Functional Performance and Respiratory Function

General information

Reason for update
Acronym
IRCT registration information
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
Registration date
2025-07-21, 1404/04/30
Registrant information
Name
maryam valikhani
Name of organization / entity
The University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 5333 5952
Email address
m.valikhani@spr.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-22, 1404/05/31
Expected recruitment end date
2025-11-05, 1404/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Other
Inclusion/Exclusion criteria
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
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
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.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Street, Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۵-۳۱۹
Approval date
2025-07-10, 1404/04/19
Ethics committee reference number
1404.090

Health conditions studied

1

Description of health condition studied
Intellectual Disabilities
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Functional Performance and Respiratory Function
Timepoint
Eight Weeks
Method of measurement
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.

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Career Support Center and Supported Production Workshop for the Disabled, Pegah Omid,
Full name of responsible person
Ziba Rabani Khorasgani
Street address
No. 9, Alley 7 (Hadizadeh), Najarbashi Alley, Jihad St.
City
Isfahan
Province
Isfehan
Postal code
818388794409
Phone
+98 913 165 5235
Email
s.employment96@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Isfahan
Full name of responsible person
Vice President of Research and Technology
Street address
Isfahan - Azadi Square - Isfahan University
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2128
Email
research.deputy@dean.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Isfahan
Proportion provided by this source
50
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 Isfahan
Full name of responsible person
Maryam Valikhani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Rehabilitation management
Street address
No. 29,opposite Saadi Street, Golestan Boulevard
City
Dehaghan
Province
Isfehan
Postal code
8641653351
Phone
+98 31 5333 5952
Email
maryamvalikhani801@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Maryam Valikhani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Rehabilitation management
Street address
No. 29,opposite Saadi Street, Golestan Boulevard
City
Dehaghan
Province
Isfehan
Postal code
8641653351
Phone
+98 31 5333 5952
Email
maryamvalikhani801@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Maryam Valikhani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Rehabilitation management
Street address
No. 29,opposite Saadi Street, Golestan Boulevard
City
Dehaghan
Province
Isfehan
Postal code
8641653351
Phone
+98 31 5333 5952
Email
maryamvalikhani801@gmail.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
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
Access period starts 6 months after results are published.
To whom data/document is available
My data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
To receive data/documents, please contact Ms. Maryam Valikhani at 09338178219 and address: Isfahan, Hezar Jerib, University of Isfahan.
What processes are involved for a request to access data/document
There is no further information
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