Adolescent BehaviorNCT03847259
Mechanical Posture Changes in Adolescent Female at Public Schools Compared to International Schools
An observational study of Adolescent Behavior, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to determine different mechanical posture changes in adolescent females at public schools compared to international schools. Read more about this study
- Who is it for?
- Ages 13 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior
- What is being tested?
- mechanical posture changes
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 Aug 2020
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Study population: Adolescent female at schools.
Who may be able to join
- Adolescent female at schools.
- Their age will be ranged from 13 to 17 years.
- BMI more than 20.
- Initiated menstrual cycle.
Who cannot join
- Asthma and chronic respiratory disease.
- History of upper and lower limb injury.
- Under weight subjects.
- Females with congenital spinal deformities.
- Diabetes, cardiopulmonary diseases and any physical impairment that prevent following the study program.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine different mechanical posture changes in adolescent females at public schools compared to international schools.
Read the detailed description
Two hundred adolescent female subjects at public schools and in this study. All subjects will be recruited from different schools. 1-Group A: it will be consists of 200 adolescent female from public schools, will be evaluated by Posture screen mobile, (BackPEI) questionnaire , VISUAL ANALOG SCALE (VAS)and Depression Anxiety Stress Scales-21(DASS-21).
2- Group B: it will be consists of 200 adolescent female from international schools, will be evaluated by Posture screen mobile, (BackPEI) questionnaire , VISUAL ANALOG SCALE (VAS) and Depression Anxiety Stress Scales-21(DASS-21).
- Conditions
- Adolescent Behavior
- Being tested
- mechanical posture changes
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical posture changesDiagnostic test
evaluated by Posture screen mobile, (BackPEI) questionnaire , VISUAL ANALOG SCALE (VAS), Depression Anxiety Stress Scales-21(DASS-21).
| Study group | Role | What they receive |
|---|---|---|
| A(public school) | it will be consists of 200 adolescent female from public schools, their age will be ranged from 13 to 17 years, initiated menstrual cycle and BMI more than 20.mechanical posture changes will be evaluated by Posture screen mobile. back pain and life style will be evaluated by (BackPEI) questionnaire.
pain will be evaluated by VISUAL ANALOG SCALE(VAS) .stress will be evaluated by Depression Anxiety Stress Scales-21(DASS-21). Receives: Diagnostic Test: mechanical posture changes | |
| B(international school) | it will be consists of 200 adolescent female from international schools their age will be ranged from 13 to 17 years, initiated menstrual cycle and BMI more than 20.mechanical posture changes will be evaluated by Posture screen mobile. back pain and life style will be evaluated by (BackPEI) questionnaire .pain will be evaluated by VISUAL ANALOG SCALE (VAS).stress will be evaluated by Depression Anxiety Stress Scales-21(DASS-21). Receives: Diagnostic Test: mechanical posture changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
posture deviations
Lateral shift from the midline and tilting through frontal and lateral views.
Measured: up to 6months
Secondary outcomes (6)
weight
Anthropometric measurement measure by kilogram (kg).
Measured: up to 6months
height
Anthropometric measurement measure by centimeter (cm).
Measured: up to 6months
body mass index (BMI).
calculated by dividing weight (in kilograms) by your height (in metres squared). kg/m2
Measured: up to 6 months
Back Pain and Body Posture Evaluation Instrument (BackPEI) questionnaire
Back Pain and Body Posture Evaluation Instrument .The BackPEI questionnaire consists of 21 closed questions, which address the occurrence, frequency and intensity of pain, as well as questions on demographic (age, gender) and behavioral factors (level of exercise, competitive or non-competitive practice of exercise, daily hours watching television and using the computer, number of daily hours of sleep, reading and/or studying in bed, and postures in activities of daily living.
Measured: up to 6months
Visual analogue scale
Numerical pain rating scale (minimum score 0 and maximum score 10) ,Instruct the patient to choose a number from 0 to 10 that best describes their current pain. 0 would mean "no pain" and 10 would mean "worst possible pain.
Measured: up to 6months
Depression Anxiety Stress Scales-21(DASS-21)
Was developed to provide a self-report measure of anxiety, depression and stress signals. During the development process.Questionnaire consists of 21 questions,seven questions for depression ,seven for anxiety and seven for stress assessment.The responses are given on a 4-point Likert scale, ranging from zero if "I strongly disagree" to 3 if "I totally agree". Overall scores for the three constructs are calculated as the sum of scores for the relevant seven items multiplied by two. Ranges of scores correspond to levels of symptoms, ranging from "normal" to "extremely serious
Measured: up to 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Mar 2019
- Primary completion17 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAhmed, Cairo University
- Investigators
- fahema me okeel, phD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847259
- Sponsor's protocol ID
- MPCAF
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Posture Changes in Adolescent Female at Public Schools Compared to International Schools
- ClinicalTrials.gov ID
- NCT03847259
- Acronym / sponsor ID
- MPCAF
- Conditions
- Adolescent Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine different mechanical posture changes in adolescent females at public schools compared to international schools.
Detailed description
Two hundred adolescent female subjects at public schools and in this study. All subjects will be recruited from different schools. 1-Group A: it will be consists of 200 adolescent female from public schools, will be evaluated by Posture screen mobile, (BackPEI) questionnaire , VISUAL ANALOG SCALE (VAS)and Depression Anxiety Stress Scales-21(DASS-21).
2- Group B: it will be consists of 200 adolescent female from international schools, will be evaluated by Posture screen mobile, (BackPEI) questionnaire , VISUAL ANALOG SCALE (VAS) and Depression Anxiety Stress Scales-21(DASS-21).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A(public school) | – | Diagnostic Test: mechanical posture changesit will be consists of 200 adolescent female from public schools, their age will be ranged from 13 to 17 years, initiated menstrual cycle and BMI more than 20.mechanical posture changes will be evaluated by Posture screen mobile. back pain and life style will be evaluated by (BackPEI) questionnaire. pain will be evaluated by VISUAL ANALOG SCALE(VAS) .stress will be evaluated by Depression Anxiety Stress Scales-21(DASS-21). |
| B(international school) | – | Diagnostic Test: mechanical posture changesit will be consists of 200 adolescent female from international schools their age will be ranged from 13 to 17 years, initiated menstrual cycle and BMI more than 20.mechanical posture changes will be evaluated by Posture screen mobile. back pain and life style will be evaluated by (BackPEI) questionnaire .pain will be evaluated by VISUAL ANALOG SCALE (VAS).stress will be evaluated by Depression Anxiety Stress Scales-21(DASS-21). |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Adolescent female at schools.
Key inclusion criteria (4 listed)
- Adolescent female at schools.
- Their age will be ranged from 13 to 17 years.
- BMI more than 20.
- Initiated menstrual cycle.
Key exclusion criteria (5 listed)
- Asthma and chronic respiratory disease.
- History of upper and lower limb injury.
- Under weight subjects.
- Females with congenital spinal deformities.
- Diabetes, cardiopulmonary diseases and any physical impairment that prevent following the study program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical posture changesevaluated by Posture screen mobile, (BackPEI) questionnaire , VISUAL ANALOG SCALE (VAS), Depression Anxiety Stress Scales-21(DASS-21). | Diagnostic test | A(public school), B(international school) |
Primary outcome
posture deviations
Time frame: up to 6months
Lateral shift from the midline and tilting through frontal and lateral views.
6 secondary outcomes
weight
Time frame: up to 6months
height
Time frame: up to 6months
body mass index (BMI).
Time frame: up to 6 months
Back Pain and Body Posture Evaluation Instrument (BackPEI) questionnaire
Time frame: up to 6months
Visual analogue scale
Time frame: up to 6months
Depression Anxiety Stress Scales-21(DASS-21)
Time frame: up to 6months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fahema me okeel, phD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Behavior, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
posture deviations (time frame: up to 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021; AzTrials last refreshed its copy on 31 Oct 2026.