NCT06063447

Brief Summary

The aim of this study was to investigate relationship between the type and severity of scoliosis and pelvic floor dysfunctions in individuals with adolescent idiopathic scoliosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

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

Study Start

First participant enrolled

May 2, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

September 21, 2023

Last Update Submit

September 27, 2023

Conditions

Scoliosis IdiopathicPelvic Floor Disorders

Outcome Measures

Primary Outcomes (5)

  • Scoliosis

    With X-Ray

    10 minutes

  • Posture Analysis

    With Posture Screen Mobile Application

    5 minutes

  • Pelvic Floor Muscle Activity

    With Real Time Transabdominal Ultrasound

    15 Minutes

  • Pelvic Floor Dysfunction

    With Pelvic Floor Distress Inventory

    5 minutes

  • Dysfunctional Voiding

    With Dysfunctional Voiding Scoring System

    10 minutes

Interventions

ExaminationOTHER

Posture Evaluation, Scoliosis Examination, Pelvic Floor Assesments

Eligibility Criteria

Age11 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Individuals aged between 11-18 years and followed up in physiotherapy centers that met the inclusion criteria were selected.

You may qualify if:

  • Those with adolescent idiopathic scoliosis diagnosed above 10' degree,
  • Under 19 years of age diagnosed with AIS,
  • Individuals whose consent was obtained from their families to participate in the study

You may not qualify if:

  • Those with congenital scoliosis,
  • Those with a history of neuromuscular disease,
  • Diagnosed with any systemic disease other than AIS,
  • Those with a history of malignancy and/or ongoing treatment,
  • Those with a history of urogenital diseases and surgical history,
  • Individuals with previous spinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Batuhan Ibrahim

Mersin, Lefkosa, 99258, Turkey (Türkiye)

Location

Related Publications (5)

  • Perkins, J., Boyer, A., Mcleish, A., & Grossnickle, K. (2012). Idiopathic scoliosis and pelvic floor dysfunction. International Journal of Therapy and Rehabilitation, 19(2), 106-110.

    BACKGROUND

  • Meyer I, McArthur TA, Tang Y, McKinney JL, Morgan SL, Richter HE. Pelvic Floor Symptoms and Spinal Curvature in Women. Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22(4):219-23. doi: 10.1097/SPV.0000000000000271.

    PMID: 27054800BACKGROUND

  • Naziri Q, Detolla J, Hayes W, Burekhovich S, Merola A, Akamnanu C, Paulino CB. A Systematic Review of All Smart Phone Applications Specifically Aimed for Use as a Scoliosis Screening Tool. J Long Term Eff Med Implants. 2018;28(1):25-30. doi: 10.1615/JLongTermEffMedImplants.2017020737.

    PMID: 29772989BACKGROUND

  • Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.

    PMID: 29435499BACKGROUND

  • Ahmed SA., Othman NA., Sabet NA., & Salwa F. (2021). Validity and Reliability of Posture Screen Mobile Application in Adolescent Idiopathic Scoliosis. The Medical Journal of Cairo University, 89(June), 737-743.

    BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Salih Angın, Prof.

    Cyprus International University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2023

First Posted

October 2, 2023

Study Start

May 2, 2023

Primary Completion

September 4, 2023

Study Completion

September 15, 2023

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)