Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458621
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2024-06-09
Brief Title:
Weight Categories and Center of Pressure Sway
Sponsor:
Delta University for Science and Technology
Organization:
Delta University for Science and Technology
Study Overview
Official Title:
Static Posturographic Analysis for Different Weight Categories in Adolescents
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be conducted to investigate the impact of different weight categories of adolescents on the center of pressure displacement throughout posturographic analysis test
Detailed Description:
-Several studies have reported that obesity affects postural stability through center of pressure displacement in adult elderly and children However there are no studies illustrate the effect of variant weight categories obese overweight normal weight underweight on static balance and postural stability by posturographic analysis in adolescent at age 16-18 years old
I-Subjects
200 adolescents from both sexes will be assigned to this study They will be selected randomly from a secondary school student and first level university students They will be selected according to the following criteria
Inclusion criteria
Their age will be ranging from 16 to 18 years
The sample will be selected according to BMI-for Age percentile growth charts according to CDC Centers for Disease Control and Prevention appendix-1 NCHS 2014
All participant will be free from any musculoskeletal deformities
All participant is free of peripheral neuropathic diseases
They have no visual or auditory or vestibular disorders
They will able to understand follow and execute instructions included in the testing analysis procedures
They will be assigned into four group of equal numbers according to BMI body mass index for age percentile obese group n50 overweight group n50 underweight group n50 and normal group weight n50 They will be assigned as following
Underweight group A
This group will be underweight group according to BMI- for age percentile growth chart ranged from BMI-for-age 5th percentiles
Normal weight group B
This group will be with normal weight according to BMI- for age percentile growth chart which ranged from BMI-for-age 5th to 85th percentiles
Overweight group C
This group will be an overweight group according to BMI- for age percentile growth chart which ranged from BMI-for-age 85th to 95th percentiles
Obese group D
This group will be obese group according to BMI- for age percentile growth chart which ranged from BMI-for-age 95th percentiles and 99th percentile
II-Instrumentations
A For selecting subjects
Use the CDC Centers for Disease Control and Prevention growth charts for children and teens aged 2 through 20 years Comparing body measurements with the appropriate age- and sex-specific growth chart enables health care providers to monitor growth and identify potential health- or nutrition-related problems NCHSCDC 2014
B For evaluation
1 Electronic body weight scale for weight and Height measurements 2 Force platform FREEMED platform and FREESTEP software Sensor Medica Inc Via Umberto Agnelli 11 00012 Guidonia Montecelio Rome Italy were validated for both balance and gait analysis
III- Procedures
For sample selection
For subjects selection use electronic body scale TCS-200-RT
1 Weight
A platform electronic scale was used to determine weight TCS-200-RT The participants will wear minimum clothes removed jacket shoes and jewelry stand stationary in the middle of the scales platform without touching anything and their body weight will be evenly distributed on both feet
A stadiometer TCS-200-RT with a vertical scale of 2 m and a sliding headpiece will be used to measure height to the closest 05 cm The participants heights will be measured without their shoes on Participants will stand in the Frankfort horizontal plane The barefoot with eyes open Initially they were instructed to stand relaxed with their feet separated at a comfortable width about shoulder-width apart and arms at sides in hanged position along the body and looking straight ahead and ankle-to-ankle angle 45 and with the feet in a tandem position The back of the head heels buttocks and scapulae will be all against the vertical surface of the stadiometer
Plate form method of analysis
1 Testing procedures
-The experiments will be conducted in a quiet room the force platform will be positioned in the middle During the static standing trial each subject will permitted to speak occasionally with a partner sitting or standing in front of him or her about 2 meters away at any subject chosen by him or her the collected data during the 80 sec of the trials will be analyzed for a-p direction COP a-p and m-l direction COP m-l
-The test protocols usually include a Sensory Organization Test SOT During the test the subject is instructed to stand still and quietly with eyes open or closed depending on which of the six tests is being administered The subject performs multiple trials per test
the testing protocol is consisted of six trials in the 1st trial is bilateral eye opened EO for 20 sec in the 2nd trail is bilateral eye closed EC for 20 sec in 3rd trial is unilateral RT leg with EO for 10 sec in 4th trail is unilateral RT leg EC for 10 sec in the 5th trail is unilateral LT leg with EO for 10 sec and in the 6th trail is unilateral LT leg EC for 10 sec The total test duration is 80 sec
2 Testing parameters outcomes
The following parameters will be tested
1 Anteroposterior AP sway length rang of COP trajectory on Y-Axis Delta Y
2 Mediolateral ML sway length rang of COP trajectory on x-Axis Delta X
3 Average COP speed or velocity
I-Subjects
200 adolescents from both sexes will be assigned to this study They will be selected randomly from a secondary school student and first level university students They will be selected according to the following criteria
Inclusion criteria
Their age will be ranging from 16 to 18 years
The sample will be selected according to BMI-for Age percentile growth charts according to CDC Centers for Disease Control and Prevention appendix-1 NCHS 2014
All participant will be free from any musculoskeletal deformities
All participant is free of peripheral neuropathic diseases
They have no visual or auditory or vestibular disorders
They will able to understand follow and execute instructions included in the testing analysis procedures
They will be assigned into four group of equal numbers according to BMI body mass index for age percentile obese group n50 overweight group n50 underweight group n50 and normal group weight n50 They will be assigned as following
Underweight group A
This group will be underweight group according to BMI- for age percentile growth chart ranged from BMI-for-age 5th percentiles
Normal weight group B
This group will be with normal weight according to BMI- for age percentile growth chart which ranged from BMI-for-age 5th to 85th percentiles
Overweight group C
This group will be an overweight group according to BMI- for age percentile growth chart which ranged from BMI-for-age 85th to 95th percentiles
Obese group D
This group will be obese group according to BMI- for age percentile growth chart which ranged from BMI-for-age 95th percentiles and 99th percentile
II-Instrumentations
A For selecting subjects
Use the CDC Centers for Disease Control and Prevention growth charts for children and teens aged 2 through 20 years Comparing body measurements with the appropriate age- and sex-specific growth chart enables health care providers to monitor growth and identify potential health- or nutrition-related problems NCHSCDC 2014
B For evaluation
1 Electronic body weight scale for weight and Height measurements 2 Force platform FREEMED platform and FREESTEP software Sensor Medica Inc Via Umberto Agnelli 11 00012 Guidonia Montecelio Rome Italy were validated for both balance and gait analysis
III- Procedures
For sample selection
For subjects selection use electronic body scale TCS-200-RT
1 Weight
A platform electronic scale was used to determine weight TCS-200-RT The participants will wear minimum clothes removed jacket shoes and jewelry stand stationary in the middle of the scales platform without touching anything and their body weight will be evenly distributed on both feet
A stadiometer TCS-200-RT with a vertical scale of 2 m and a sliding headpiece will be used to measure height to the closest 05 cm The participants heights will be measured without their shoes on Participants will stand in the Frankfort horizontal plane The barefoot with eyes open Initially they were instructed to stand relaxed with their feet separated at a comfortable width about shoulder-width apart and arms at sides in hanged position along the body and looking straight ahead and ankle-to-ankle angle 45 and with the feet in a tandem position The back of the head heels buttocks and scapulae will be all against the vertical surface of the stadiometer
Plate form method of analysis
1 Testing procedures
-The experiments will be conducted in a quiet room the force platform will be positioned in the middle During the static standing trial each subject will permitted to speak occasionally with a partner sitting or standing in front of him or her about 2 meters away at any subject chosen by him or her the collected data during the 80 sec of the trials will be analyzed for a-p direction COP a-p and m-l direction COP m-l
-The test protocols usually include a Sensory Organization Test SOT During the test the subject is instructed to stand still and quietly with eyes open or closed depending on which of the six tests is being administered The subject performs multiple trials per test
the testing protocol is consisted of six trials in the 1st trial is bilateral eye opened EO for 20 sec in the 2nd trail is bilateral eye closed EC for 20 sec in 3rd trial is unilateral RT leg with EO for 10 sec in 4th trail is unilateral RT leg EC for 10 sec in the 5th trail is unilateral LT leg with EO for 10 sec and in the 6th trail is unilateral LT leg EC for 10 sec The total test duration is 80 sec
2 Testing parameters outcomes
The following parameters will be tested
1 Anteroposterior AP sway length rang of COP trajectory on Y-Axis Delta Y
2 Mediolateral ML sway length rang of COP trajectory on x-Axis Delta X
3 Average COP speed or velocity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None