- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03894865
Screening and Prevalence of Adolescent Idiopathic Scoliosis in Selected Urban and Countryside Schools in Egypt
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Cairo, Egypt, egypt
- Faculty of Physical Therapy, Cairo University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: urban school
Male students from selected urban schools undergo screening for idiopathic scoliosis
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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
Andre navn:
Measurement of the angle of trunk rotation (ATR) by using a scoliometer HD smartphone application.
Andre navn:
|
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Eksperimentell: countryside schools
Male students from selected countryside schools undergo screening for idiopathic scoliosis
|
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
Andre navn:
Measurement of the angle of trunk rotation (ATR) by using a scoliometer HD smartphone application.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Positive Adam's forward bending test
Tidsramme: 10 minutes
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Proportion of patients with a positive Adam's forward bending test
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10 minutes
|
|
degree of trunk rotation
Tidsramme: 15 minutes
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scoliometer HD reading >7 degrees (=>20 degrees Cobb angle) Proportion of patients with more than 7 degree
|
15 minutes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
screening
Tidsramme: 15 minutes
|
percentage of childerns with idiopathic scoliosis
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15 minutes
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- scoliosis in Egypt
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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