NCT03894865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

March 27, 2019

Last Update Submit

July 28, 2019

Conditions

Keywords

scoliosis, prevalencescreening, Egypt

Outcome Measures

Primary Outcomes (2)

  • Positive Adam's forward bending test

    Proportion of patients with a positive Adam's forward bending test

    10 minutes

  • degree of trunk rotation

    scoliometer HD reading \>7 degrees (=\>20 degrees Cobb angle) Proportion of patients with more than 7 degree

    15 minutes

Secondary Outcomes (1)

  • screening

    15 minutes

Study Arms (2)

urban school

EXPERIMENTAL

Male students from selected urban schools undergo screening for idiopathic scoliosis

Other: procedure1Other: procedure2

countryside schools

EXPERIMENTAL

Male students from selected countryside schools undergo screening for idiopathic scoliosis

Other: procedure1Other: procedure2

Interventions

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

Also known as: Adam's forward bend test
countryside schoolsurban school

Measurement of the angle of trunk rotation (ATR) by using a scoliometer HD smartphone application.

Also known as: Angle of trunk rotation
countryside schoolsurban school

Eligibility Criteria

Age10 Years - 15 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age range from 10 to 15 years.
  • Males students.
  • Students who have structural scoliosis.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical therapy, Cairo University

Cairo, egypt, Egypt

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • karima A Hassan, PhD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 27, 2019

First Posted

March 29, 2019

Study Start

April 1, 2019

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 30, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations