NCT06023992

Brief Summary

Idiopathic scoliosis is a spinal deformity that occurs in adolescent girls and boys and is more progressive in girls. The cosmetic changes caused by the scoliotic spine cause negativity in perception of appearance and psychosocial problems in pubertal individuals, especially in girls. It is thought that brace used in conservative treatment increase this negativity in body image and affect compliance with treatment. In this study, it was aimed to determine whether there is an effect on the individual's compliance with the programmed treatment by investigating the perception of body appearance, self-esteem and quality of life of adolescent girls with idiopathic scoliosis. In this context, forty adolescent girls diagnosed with "idiopathic scoliosis" and followed in the "Formed Healthcare Scoliosis Unit" were included in the study. In the study, Walter Reed Visual Evaluation Scale was used to evaluate perception of appearance, Coopersmith Self-Esteem Inventory to evaluate self-esteem, and SRS-22 Scoliosis Patient Questionnaire to evaluate quality of life. Scoliosis Treatment Compliance Scale, which was developed by us and whose validity and reliability study was planned, was used to evaluate compliance with the treatment program.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

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

Study Start

First participant enrolled

February 15, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2016

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2016

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
Last Updated

September 5, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

August 22, 2023

Last Update Submit

September 1, 2023

Conditions

Keywords

Adolescent Idiopathic Scoliosisperception of appearanceself-esteemquality of lifecompliance

Outcome Measures

Primary Outcomes (4)

  • Walter Reed Visual Assessment (WRVAS)

    It is a valid scale consisting of 7 questions, each of which includes 5 visuals and evaluates the physical deformity perceived by the patients.The selected images are scored as the lowest "1" and the highest "5", and the highest total score is 35 and the lowest is 5. It is accepted that the higher the score, the more negative-evil perception of the deformity.

    Baseline

  • Coopersmith Self-Esteem Inventory

    A valid and reliable short form of 25 questions adapted to children in the same age group was used to determine the level of self-esteem. Those who say 'No' to a negative statement and 'Yes' to a positive statement in the inventory get 1 point for each question. The level of self-esteem obtained is determined as "low" or "high" based on the average score of the group in which the person belongs.

    Baseline

  • Scoliosis Research Society-22

    It is a scoliosis-specific, valid and reliable quality of life scale that questions pain, body image perception, function/activity, mental health, and satisfaction with treatment. A minimum of 1 point (worst) and a maximum of 5 points (best) are taken for each question. Scoring is obtained by dividing the total score from each section by the number of questions in that section. As a result of the scoring, it is accepted that the higher the score, the higher the quality of life.

    Baseline

  • Scoliosis Treatment Compliance Scale

    It is a scale prepared by us to evaluate compliance with the treatment program and recommended Activities of Daily Living in individuals with scoliosis. The patient can get a total of 28 points, with a minimum of 1 and a maximum of 4 points from each statement in the scale. It is observed that the higher the score, the higher the treatment compliance.

    Baseline

Eligibility Criteria

Age12 Years - 17 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIn prevalence studies for AIS, it has been reported that the incidence in girls is higher than in boys. In addition, AIS is more progressive in girls and the need for treatment is greater than in boys.
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

A clinic where individuals with scoliosis are treated and followed up by specialist physician and physiotherapists, as well as a scoliosis brace production and application center: Formed Healthcare Orthotics and Prosthesis Center - Scoliosis Unit.

You may qualify if:

  • Provided that the family and the child volunteer to participate in the study,
  • Being diagnosed with idiopathic scoliosis
  • Girl gender,
  • Be 12 years or older,
  • Using and still wearing braces for at least 3 months due to AIS,
  • Having been prescribed an exercise program

You may not qualify if:

  • Having had previous spine surgery,
  • Presence of a psychological or psychiatric diagnosis,
  • Presence of any neurological, muscular, rheumatic or orthopedic diseases accompanying scoliosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Pineda S, Bago J, Gilperez C, Climent JM. Validity of the Walter Reed Visual Assessment Scale to measure subjective perception of spine deformity in patients with idiopathic scoliosis. Scoliosis. 2006 Nov 8;1:18. doi: 10.1186/1748-7161-1-18.

  • Asher M, Min Lai S, Burton D, Manna B. Discrimination validity of the scoliosis research society-22 patient questionnaire: relationship to idiopathic scoliosis curve pattern and curve size. Spine (Phila Pa 1976). 2003 Jan 1;28(1):74-8. doi: 10.1097/00007632-200301010-00017.

  • Chan SL, Cheung KM, Luk KD, Wong KW, Wong MS. A correlation study between in-brace correction, compliance to spinal orthosis and health-related quality of life of patients with Adolescent Idiopathic Scoliosis. Scoliosis. 2014 Feb 22;9(1):1. doi: 10.1186/1748-7161-9-1.

  • Donzelli S, Zaina F, Negrini S. Compliance monitor for scoliosis braces in clinical practice. J Child Orthop. 2015 Dec;9(6):507-8. doi: 10.1007/s11832-015-0703-7. Epub 2015 Nov 2. No abstract available.

  • Helfenstein A, Lankes M, Ohlert K, Varoga D, Hahne HJ, Ulrich HW, Hassenpflug J. The objective determination of compliance in treatment of adolescent idiopathic scoliosis with spinal orthoses. Spine (Phila Pa 1976). 2006 Feb 1;31(3):339-44. doi: 10.1097/01.brs.0000197412.70050.0d.

  • Matamalas A, Bago J, D'Agata E, Pellise F. Body image in idiopathic scoliosis: a comparison study of psychometric properties between four patient-reported outcome instruments. Health Qual Life Outcomes. 2014 Jun 3;12:81. doi: 10.1186/1477-7525-12-81.

  • Meyer C, Haumont T, Gauchard GC, Leheup B, Lascombes P, Perrin PP. The practice of physical and sporting activity in teenagers with idiopathic scoliosis is related to the curve type. Scand J Med Sci Sports. 2008 Dec;18(6):751-5. doi: 10.1111/j.1600-0838.2007.00750.x. Epub 2008 Feb 2.

  • Negrini S, Antonini G, Carabalona R, Minozzi S. Physical exercises as a treatment for adolescent idiopathic scoliosis. A systematic review. Pediatr Rehabil. 2003 Jul-Dec;6(3-4):227-35. doi: 10.1080/13638490310001636781.

  • Negrini S, Aulisa AG, Aulisa L, Circo AB, de Mauroy JC, Durmala J, Grivas TB, Knott P, Kotwicki T, Maruyama T, Minozzi S, O'Brien JP, Papadopoulos D, Rigo M, Rivard CH, Romano M, Wynne JH, Villagrasa M, Weiss HR, Zaina F. 2011 SOSORT guidelines: Orthopaedic and Rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis. 2012 Jan 20;7(1):3. doi: 10.1186/1748-7161-7-3.

  • Rivett L, Stewart A, Potterton J. The effect of compliance to a Rigo System Cheneau brace and a specific exercise programme on idiopathic scoliosis curvature: a comparative study: SOSORT 2014 award winner. Scoliosis. 2014 May 30;9:5. doi: 10.1186/1748-7161-9-5. eCollection 2014.

  • Schwieger T, Campo S, Weinstein SL, Dolan LA, Ashida S, Steuber KR. Body Image and Quality-of-Life in Untreated Versus Brace-Treated Females With Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2016 Feb;41(4):311-9. doi: 10.1097/BRS.0000000000001210.

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • İrem Çetinkaya, MSc

    Haliç University

    PRINCIPAL INVESTIGATOR
  • Hürriyet G Yılmaz, MD

    Haliç University

    STUDY CHAIR
  • Melek G Yavuzer, MD

    Haliç University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 22, 2023

First Posted

September 5, 2023

Study Start

February 15, 2016

Primary Completion

June 5, 2016

Study Completion

June 15, 2016

Last Updated

September 5, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share