Adolescent Idiopathic ScoliosisNCT04092335
Evaluation of Adam's Forward Bend Test and Smartphone Application in Screening of Adolescent Idiopathic Scoliosis
An observational study of Adolescent Idiopathic Scoliosis, run by Cairo University at 1 site in Egypt.
Trial summary
Scoliosis is a lateral curvature of the spine when the Cobb´s angle more than 10˚ on the frontal plane. Curve detection before skeletal maturation gives a good opportunity for early treatment or prevention of curve progression. Read more about this study
- Who is it for?
- Ages 10 to 15 years, men only
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- How many people
- 840 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 8 Aug 2019
- 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 10 to 15 years
- Men only
- Child
Study population: Male students with age range 10-15 years
Who may be able to join
- Age range from 10 to 15 year.
- Males ( parents of girls refused their participation).
- Students who have structural scoliosis.
Who cannot join
- Congenital deformities.
- Neuromuscular disorder (Cerebral palsy and spinal muscle atrophy).
- Syndromic disorders (Muscular dystrophy, Osteogenesis imperfect and spinabifida).
Trial locations and contacts
1 site in 1 country.
About this study
Scoliosis is a lateral curvature of the spine when the Cobb´s angle more than 10˚ on the frontal plane. Curve detection before skeletal maturation gives a good opportunity for early treatment or prevention of curve progression. Purpose of this study was to evaluate Adam's Forward Bend Test and Scoliometer HD in screening of Adolescent Idiopathic Scoliosis
Read the detailed description
The student was asked to stand erect, knees straight, feet at the same level and hands freely hanging.
They was observed from the back for shoulders, pelvic, and knees level. Student was asked to bend forward with his knees straight, feet together and hands freely and loosely hanged(Forward Bend Test).
Scoliosis was detected with rib cage rotation and hump appearance (positive test).
Absence of hump appearance means negative test. After Forward Bend, the students were screened using the Scoliometer HD Application.
The students were asked to bend forward with arms dangling and palms pressed together. The smart phone (Scoliometer HD) was placed on the student back with the central dark area in the application placed on the spinous processes of the lumber and thoracic regions to measure the angle of trunk rotation. Students with a scoliometer HD reading ≥7 degrees (≥20 ̊ Cobb's angle) were referred to orthopedic consultation and their parents were informed about the findings of the screening by the school manager and social worker.
Then the data were collected for statistical analysis
- Conditions
- Adolescent Idiopathic Scoliosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of hump measured by Forward Bend Test
Students were asked to bend forward with his knees straight, feet together and hands freely and loosely hanged. Scoliosis were detected with rib cage rotation and hump appearance (positive test). Absence of hump appearance means negative test.
Measured: 20 minutes
Angle of trunk rotation (ATR) measured by Scoliometer HD application
The students were asked to bend forward with arms dangling and palms pressed together. The smart phone (Scoliometer HD) was placed on the student back with the central dark area in the application placed on the spinous processes of the lumber and thoracic regions to measure the angle of trunk rotation.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start1 Oct 2018
- Primary completion1 Apr 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies 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
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karima Abdelaty Hassan, Cairo University
- Investigators
- Nasr A. Abdelkader, PhD, Principal investigator, Lecturer,Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092335
- Sponsor's protocol ID
- P.T.REC/012/002051
- Status last verified
- Sep 2019
- First submitted
- 14 Sep 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adam's Forward Bend Test and Smartphone Application in Screening of Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT04092335
- Acronym / sponsor ID
- P.T.REC/012/002051
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 17 Sep 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.
Scoliosis is a lateral curvature of the spine when the Cobb´s angle more than 10˚ on the frontal plane. Curve detection before skeletal maturation gives a good opportunity for early treatment or prevention of curve progression. Purpose of this study was to evaluate Adam's Forward Bend Test and Scoliometer HD in screening of Adolescent Idiopathic Scoliosis
Detailed description
The student was asked to stand erect, knees straight, feet at the same level and hands freely hanging.
They was observed from the back for shoulders, pelvic, and knees level. Student was asked to bend forward with his knees straight, feet together and hands freely and loosely hanged(Forward Bend Test).
Scoliosis was detected with rib cage rotation and hump appearance (positive test).
Absence of hump appearance means negative test. After Forward Bend, the students were screened using the Scoliometer HD Application.
The students were asked to bend forward with arms dangling and palms pressed together. The smart phone (Scoliometer HD) was placed on the student back with the central dark area in the application placed on the spinous processes of the lumber and thoracic regions to measure the angle of trunk rotation. Students with a scoliometer HD reading ≥7 degrees (≥20 ̊ Cobb's angle) were referred to orthopedic consultation and their parents were informed about the findings of the screening by the school manager and social worker.
Then the data were collected for statistical analysis
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 15 years
- Sex
- Male only
- Age groups
- Child
- Study population
- Male students with age range 10-15 years
Key inclusion criteria (3 listed)
- Age range from 10 to 15 year.
- Males ( parents of girls refused their participation).
- Students who have structural scoliosis.
Key exclusion criteria (3 listed)
- Congenital deformities.
- Neuromuscular disorder (Cerebral palsy and spinal muscle atrophy).
- Syndromic disorders (Muscular dystrophy, Osteogenesis imperfect and spinabifida).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Appearance of hump measured by Forward Bend Test
Time frame: 20 minutes
Students were asked to bend forward with his knees straight, feet together and hands freely and loosely hanged. Scoliosis were detected with rib cage rotation and hump appearance (positive test). Absence of hump appearance means negative test.
Angle of trunk rotation (ATR) measured by Scoliometer HD application
Time frame: 20 minutes
The students were asked to bend forward with arms dangling and palms pressed together. The smart phone (Scoliometer HD) was placed on the student back with the central dark area in the application placed on the spinous processes of the lumber and thoracic regions to measure the angle of trunk rotation.
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 23 Sep 2019.
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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.
Nasr A. Abdelkader, PhD principal investigator
Lecturer,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 Idiopathic Scoliosis, 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 3 inclusion and 3 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 23 Sep 2019. 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?
Appearance of hump measured by Forward Bend Test (time frame: 20 minutes). The study lists 2 primary outcomes in all. 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 23 Sep 2019.