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Screening and Prevalence of Adolescent Idiopathic Scoliosis in Selected Urban and Countryside Schools in Egypt

Primary Purpose

Scoliosis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
procedure1
procedure2
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Scoliosis focused on measuring scoliosis, prevalence, screening, Egypt

Eligibility Criteria

10 Years - 15 Years (Child)MaleDoes not accept healthy volunteers

Inclusion criteria:

  1. Age range from 10 to 15 years.
  2. Males students.
  3. Students who have structural scoliosis.

Exclusion criteria:

  1. Congenital deformities.
  2. Recent fracture and there is a fixation in the upper or the lower extremities
  3. Neuromuscular disorder (Cerebral palsy and spinal muscle atrophy).
  4. Syndromic disorders (Muscular dystrophy, Osteogenesis imperfect, and Spina-bifida).

Sites / Locations

  • Faculty of Physical therapy, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

urban school

countryside schools

Arm Description

Male students from selected urban schools undergo screening for idiopathic scoliosis

Male students from selected countryside schools undergo screening for idiopathic scoliosis

Outcomes

Primary Outcome Measures

Positive Adam's forward bending test
Proportion of patients with a positive Adam's forward bending test
degree of trunk rotation
scoliometer HD reading >7 degrees (=>20 degrees Cobb angle) Proportion of patients with more than 7 degree

Secondary Outcome Measures

screening
percentage of childerns with idiopathic scoliosis

Full Information

First Posted
March 27, 2019
Last Updated
July 28, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03894865
Brief Title
Screening and Prevalence of Adolescent Idiopathic Scoliosis in Selected Urban and Countryside Schools in Egypt
Official Title
Screening and Prevalence of Adolescent Idiopathic Scoliosis in Selected Urban and Countryside Schools in Egypt
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Early detection of scoliosis and determination of which areas are more affected urban or countryside will help in early management. Also, this will guide the government and the community for early intervention to decrease the factors that leads to this postural abnormality. This also will guide another clinician to search for the cause of these posture deformities and to concentrate screening for special areas with special cultures.
Detailed Description
Scoliosis may have an impact on the Egyptian society as children between 10-15 years old represent 9.5 % of the population which is the third large category appendix (3). So without the early detection of adolescent idiopathic scoliosis for that age group, bad impacts will be implemented for Egyptian society by causing disabilities and psychological problems for these children. The early detection of scoliosis is of a great importance as curve detection before skeletal maturation gives a good opportunity for early treatment or prevention of curve progression. Scoliosis has a bad effect on cosmetic appearance, quality of life, Psychological well-being, disability, back Pain, breathing function. It may also progress in adulthood and need further treatment. So a multidimensional and comprehensive evaluation of scoliosis patients is necessary to design a complete therapeutic approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
scoliosis, prevalence, screening, Egypt

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
840 (Actual)

8. Arms, Groups, and Interventions

Arm Title
urban school
Arm Type
Experimental
Arm Description
Male students from selected urban schools undergo screening for idiopathic scoliosis
Arm Title
countryside schools
Arm Type
Experimental
Arm Description
Male students from selected countryside schools undergo screening for idiopathic scoliosis
Intervention Type
Other
Intervention Name(s)
procedure1
Other Intervention Name(s)
Adam's forward bend test
Intervention Description
The students will be asked to bend forward with his knees straight, feet together and hands freely and loosely hanged. if there was scoliosis the rib cage rotated and a hump appeared. Positive test indicated the presence of a rib hump and negative if there was any hump appeared
Intervention Type
Other
Intervention Name(s)
procedure2
Other Intervention Name(s)
Angle of trunk rotation
Intervention Description
Measurement of the angle of trunk rotation (ATR) by using a scoliometer HD smartphone application.
Primary Outcome Measure Information:
Title
Positive Adam's forward bending test
Description
Proportion of patients with a positive Adam's forward bending test
Time Frame
10 minutes
Title
degree of trunk rotation
Description
scoliometer HD reading >7 degrees (=>20 degrees Cobb angle) Proportion of patients with more than 7 degree
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
screening
Description
percentage of childerns with idiopathic scoliosis
Time Frame
15 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Age range from 10 to 15 years. Males students. Students who have structural scoliosis. Exclusion criteria: Congenital deformities. Recent fracture and there is a fixation in the upper or the lower extremities Neuromuscular disorder (Cerebral palsy and spinal muscle atrophy). Syndromic disorders (Muscular dystrophy, Osteogenesis imperfect, and Spina-bifida).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
karima A Hassan, PhD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical therapy, Cairo University
City
Cairo
ZIP/Postal Code
egypt
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Screening and Prevalence of Adolescent Idiopathic Scoliosis in Selected Urban and Countryside Schools in Egypt

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