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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04092335
Other study ID # P.T.REC/012/002051
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date August 8, 2019

Study information

Verified date September 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Purpose of this study was to evaluate Adam's Forward Bend Test and Scoliometer HD in screening of Adolescent Idiopathic Scoliosis


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


Recruitment information / eligibility

Status Completed
Enrollment 840
Est. completion date August 8, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers
Gender Male
Age group 10 Years to 15 Years
Eligibility Inclusion Criteria:

- Age range from 10 to 15 year.

- Males ( parents of girls refused their participation).

- Students who have structural scoliosis.

Exclusion Criteria:

- Congenital deformities.

- Neuromuscular disorder (Cerebral palsy and spinal muscle atrophy).

- Syndromic disorders (Muscular dystrophy, Osteogenesis imperfect and spinabifida).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Cairo university Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 20 minutes
Primary 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. 20 minutes
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