NCT04846296

Brief Summary

The purpose of this study is to translate and culturally adapt the quality of life profile for spinal deformities (QLPSD) to Turkish language and test the validity and reliability of Turkish version of QLPSD in patients with adolescent idiopathic scoliosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

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

April 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

April 12, 2021

Last Update Submit

December 8, 2022

Conditions

Quality of LifeSpinal DeformityScoliosis

Keywords

quality of lifescoliosisspinevalidationadaptation

Outcome Measures

Primary Outcomes (1)

  • Turkish adaptation, validity and reliability of QLPSD

    The questionnaire contains 21 items in five dimensions: psychosocial functioning (7 items), sleep disturbances (4 items), back pain (3 items), body image (4 items), and back flexibility (3 items). Responses to items use a 5-point Likert scale. The possible score range is 21- 105. Higher scores indicate poorer QoL.

    1 day

Study Arms (1)

study group

Between 10-16 years old Cobb angle 10-40 degrees Being treated with conservative treatment (brace- exercise) for scoliosis Accepted to answer the questionnaire

Other: Questionnaire

Interventions

QuestionnaireOTHER

The QLPSD, developed in Spain, was the first questionnaire designed to evaluate HRQoL in adolescents with spinal deformities. It has shown good validity and reliability. English, French and Persian versions of the QLPSD have been developed and validated. Good reliability and ease of use are mentioned in these versions. The QLPSD was designed to examine adolescents with spinal deformities and measure the effect of orthotic and surgical treatments on QoL.

Also known as: the Quality of Life Profile for Spinal Deformities
study group

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Aged between 10-16years old with scoliosis who treated by conservative management.

You may qualify if:

  • Aged between 10-16 years old
  • Cobb angle 10-40 degrees
  • Being treated with conservative treatment for spinal deformities
  • Being accepted to answer the questionnaire

You may not qualify if:

  • Being not accepted to answer the questionnaire
  • Having any mental disorder to prevent participation the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

Related Publications (2)

  • Feise RJ, Donaldson S, Crowther ER, Menke JM, Wright JG. Construction and validation of the scoliosis quality of life index in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1310-5. doi: 10.1097/01.brs.0000163885.12834.ca.

    PMID: 15928558BACKGROUND

  • Schulte TL, Thielsch MT, Gosheger G, Boertz P, Terheyden JH, Wetterkamp M. German validation of the quality of life profile for spinal disorders (QLPSD). Eur Spine J. 2018 Jan;27(1):83-92. doi: 10.1007/s00586-017-5284-3. Epub 2017 Sep 9.

    PMID: 28889338RESULT

Related Links

MeSH Terms

Conditions

Scoliosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Merve Damla Korkmaz, 1

    Kanuni Sultan Suleyman Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 15, 2021

Study Start

April 15, 2021

Primary Completion

July 15, 2022

Study Completion

November 15, 2022

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

Validation and Reability of the Quality of Life Profile for Spinal Deformities into Turkish population

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
3 months
Access Criteria
after publication

Locations

TU(1)