Investigation of Quality of Life in Adolescent Idiopathic... | NCT05242601

Studies
Investigation of Quality of Life in Adolescent Idiopathic Scoliosis

NCT05242601

Sponsor

Kirsehir Ahi Evran Universitesi

Status

Completed

Last Update Posted

Jul 26, 2022Actual

Enrollment

28Actual

Phase

Not provided

Conditions

Adolescent Idiopathic Scoliosis

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 12, 2021Actual

Primary Completion Date

Sep 30, 2021Actual

Completion Date

Oct 12, 2021Actual

First Submitted Date

Jan 27, 2022

First Submission Date that Met QC Criteria

Feb 6, 2022

First Posted Date

Feb 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2022

Last Update Posted Date

Jul 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

the aim of our study is to identify independent predictors of quality of life in AIS.

Detailed Description

Adolescent idiopathic scoliosis (AIS) is the lateral and horizontal deformity of the columna vertebralis which occurs idiopathically in adolescence ages. The aim of this study is to identify independent predictors of quality of life in AIS

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Name	Type	Description	Arm Group Labels	Other Names
	Other	no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Investigation of Quality of Life in Adolescent Idiopathic Scoliosis	Quality of life Scoliosis Research Society-22 questionnaire	4 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

volunteered for the study participants were diagnosed with adolescent idiopathic scoliosis,
between ages 10-18
Cobb angle between 10-30 degrees
Lenke curve type 1

Exclusion Criteria:

non-idiopathic scoliosis,
who had exercise contraindications
who had previous spinal surgery
who had orthotic treatment for scoliosis before
who had exercise contraindications
who had another neuromuscular
who had cardiopulmonary and rheumateulogical problem

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

volunteered for the study participants were diagnosed with adolescent idiopathic scoliosis,

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kırşehir Ahi Evran University		Kırşehir		40100	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35872563	Derived	Kaya MH, Erbahceci F, Alkan H, Kocaman H, Buyukturan B, Canli M, Buyukturan O. Factors influencing of quality of life in adolescent idiopathic scoliosis. Musculoskelet Sci Pract. 2022 Dec;62:102628. doi: 10.1016/j.msksp.2022.102628. Epub 2022 Jul 19.