NCT05377086

Brief Summary

Usage including cases followed up with rheumatism diagnosis and treatment in Istanbul University-Cerrahpasa Medical Faculty Pediatric Rheumatology Clinic, Physiotherapy and Rehabilitation Unit. The study included 50 patients with a spinal x-ray scoliosis problem, aged 8-16 years, who were diagnosed with rheumatism at least 6 months ago, whose medical treatment was stable, Risser 0-4 and exercise indication (Cobb = 10-45ͦ). Patients with additional neurological diagnosis against rheumatism, who have received any previous treatment for a spine problem, who have a mental state and who do not have the consent of their family will not be included. The cases will be divided into 2 groups by method. In the first group (n = 25), structured 3-dimensional scoliosis exercises are taught in the clinic, and the second group (n = 25) is taught conventional physiotherapy applications (posture-core applications-bennet protocols) in the clinic, and both groups are followed by the WTE method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

May 17, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

7 months

First QC Date

May 1, 2022

Last Update Submit

June 13, 2023

Conditions

ScoliosisJuvenile Idiopathic Arthritis

Keywords

scoliosisJuvenile idiopathic arthritis3D exercise

Outcome Measures

Primary Outcomes (2)

  • Cobb angle

    Measuring the scoliosis angle on x-ray is the most commonly used method. The Cobb angle is most commonly used to measure the magnitude of the curve. Measurements are made on a standing posteroanterior spine radiograph as standard. To determine the boundaries of the scoliosis, a line is drawn parallel to the upper line of the vertebra with the greatest deviation. Similarly, for the lower border, a line is drawn parallel to the lowest vertebra. Vertical lines are drawn parallel to these two lines and the angle between the two lines is measured. This angle is defined as the scoliosis angle (Cobb angle). Radiological imaging will only be applied to children who are considered to be in need by the doctor as a result of physical examination. The measurement of the Cobb angle will be made on the X-ray via the SubrotoAngleAid application.

    0-6 month

  • Trunk rotation with Scoliometer

    The trunk rotation angle will be measured with a scoliometer. It is an easy to use, reliable, practical and specially designed inclinometer in the clinical evaluation of scoliosis. It is accepted as a clinical evaluation method used in addition to radiological methods in determining the efficacy of treatment and the prognosis of scoliosis.

    0-6 month

Secondary Outcomes (5)

  • Physical deformity assesment using with The Walter Reed Visual Assessment Scale (WRVAS)

    0-6 month

  • FEV1

    0-6 month

  • FVC

    0-6 month

  • PEF

    0-6 month

  • QUALITY OF LIFE ASSESSMENT

    0-6 month

Study Arms (2)

schroth group

EXPERIMENTAL

This arm was planned as the exercise group which includes Schroth 3-Dimensional scoliosis exercise.

Other: Schroth 3-Dimensional scoliosis exercise

conventional group

EXPERIMENTAL

This arm was planned as the exercise group which includes conventional scoliosis exercise.

Other: conventional scoliosis exercise

Interventions

Schroth 3-Dimensional scoliosis exerciseOTHER

Schroth 3-Dimensional scoliosis exercises

schroth group
conventional scoliosis exerciseOTHER

conventional scoliosis exercise

conventional group

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Cases with a diagnosis of rheumatism in whom scoliosis problems were detected by spine X-ray,
  • be between the ages of 8-16,
  • Being between 0-4 in the riser,
  • Being in exercise indication (Cobb=10-45 ˚)

You may not qualify if:

  • Having an additional neurological or orthopedic diagnosis other than scoliosis accompanying rheumatism and affecting treatment results
  • Having had any surgery on the spine
  • Have had previous scoliosis treatment poor mental state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eylül Pınar Kısa

Istanbul, 34720, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ScoliosisArthritis, Juvenile

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 1, 2022

First Posted

May 17, 2022

Study Start

May 17, 2022

Primary Completion

December 15, 2022

Study Completion

February 1, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

TU(1)