Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05762354
Other study ID # GUS001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 26, 2022
Est. completion date February 10, 2024

Study information

Verified date March 2024
Source Istanbul Gelisim University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Scoliosis is a three-dimensional torsional deformation of the spine and trunk. Chest deformity and pelvic asymmetry are often seen together with spinal deformity. Adolescent idiopathic scoliosis occurs from the onset of puberty until growth plate closure and is the most common of all scoliosis. One of the most common deformities among posture disorders is known as scoliosis. The change in load distribution resulting from this three-dimensional deformation causes postural changes in patients with idiopathic scoliosis. According to a study, it is thought that postural control and central information processing efficiency may decrease as the Cobb angle increases in people with scoliosis.


Description:

Scoliosis, shoulder asymmetry, midline asymmetry, trunk shift and lower extremity length inequality. Therefore, it affects body image perception negatively by limiting physical functions and mobility. In a study conducted with individuals with AIS, it was found that as the Cobb angle increased, body image was adversely affected. It is also known that during the vertebral growth period in idiopathic scoliosis, postural reflex mechanisms originating from the proprioceptive organs and balance problems are associated with the displacement of the vertebrae. As a result of a study on vestibular effect and proprioception, it is concluded that it would be beneficial to include proprioception, balance and coordination exercises in the treatment of scoliosis. In the current literature review, no study was found that investigated the relationships between Cobb angle, proprioception, body image perception and posture variables in individuals with Adolescent Idiopathic Scoliosis. The aim of our study is to explain the relationship between some problems accompanied by scoliosis in individuals diagnosed with idiopathic scoliosis. With the results that can be obtained from our study, we aim to explain how posture, proprioception and body image perception are affected in individuals with AIS and to contribute to the exercise programs that can be given to the person in line with these results.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 10, 2024
Est. primary completion date February 10, 2024
Accepts healthy volunteers No
Gender All
Age group 10 Years to 18 Years
Eligibility Inclusion Criteria: - Having been diagnosed with adolescent idiopathic scoliosis by a doctor, - Not having cognitive, mental and psychological problems, - Continuing exercise or brace therapy. Exclusion Criteria: - Having a history of spinal surgery - Having a type of scoliosis other than idiopathic, - Presence of musculoskeletal system pathologies, - Vestibular system disorders.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Istanbul Gelisim Üniversitesi Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Gelisim University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fukuda Step Test The patient will do a 50 or 100 step counting motion with eyes open and closed. 30 degree rotation or 50 cm displacement for 50 steps relative to the starting position; For 100 steps, 31 turns of 45 degrees and displacement of 100 cm will count as a positive result. The hypoactive side of the labyrinth will be accepted as the patient's turning side. The displacement amount of the person will be measured in cm with the help of a tape measure, and the rotation amount will be measured in degrees with the help of a goniometer and recorded in the evaluation form. Baseline
Secondary Cobb Degree It can be measured with the help of a goniometer or digitally as the angle between the lines perpendicular to the parallels drawn on the corpus of the first and last vertebrae participating in the curvature. The 'Cobb' angle is the gold standard in the evaluation of scoliosis. Baseline
Secondary Trunk Rotation In the study, evaluations with scoliometer will be performed standing and sitting, in the forward bending position until the trunk is in a horizontal position and the scapula and pelvis are aligned. Vertebral rotation angle values taken from the thoracic, thoracolumbar and lumbar regions will be measured by the training physiotherapist and the highest angular value will be recorded as ATR. Baseline
Secondary Posterior Trunk Symmetry Index The POTSI parameter is defined as the sum of six indices: the frontal plane asymmetry index (C7, axilla folds and waist lines) and the three frontal plane height difference indexes (acromions, axilla folds, and waist lines). The POTSI score is calculated by placing the indices on the photograph of the patient transplanted from the posterior. Baseline
Secondary Walter Reed Visual Assessment Scale In addition to understanding the visual change caused by scoliosis, the scale used to evaluate the treatment results evaluates the deformity under 7 headings. These; spine curvature, rib protrusion, lumbar protrusion, thorax deformity relative to pelvis, trunk imbalance, shoulder and scapula asymmetry. Each of the domains is scored from 1 to 5 with worsening deformity for increasing scores. Baseline
Secondary SRS 22 Questionaire SRS-22 is the most commonly used questionnaire to evaluate quality of life in scoliosis patients. The questionnaire is a simple and practical quality of life questionnaire, which has been translated into our language and has validity and reliability, created specifically for individuals with scoliosis. Each question is scored from 1 (worst) to 5 (best) in the questionnaire, which assesses five domains: function, pain, self-image, mental health (five questions each), and treatment satisfaction (two questions). Baseline
Secondary Coronal Imbalance In the frontal plan evaluation, the plumb line is suspended in line with the midline of the sacrum, the deviation from the midline at the C7 level is measured and recorded in the evaluation form in cm. clinical threshold for plumb line distances; It will be 50 mm for C7 and 60 mm for L3. Baseline
Secondary Sagittal Index In order to detect deformities that develop different from the neutral, by hanging the pendulum from the point where the dorsal kyphosis is most prominent in the sagittal plane; At C7, T12 and L3 alignments, the distance from the pendulum to the spinous process is measured in cm and will be recorded on the evaluation form. If a value greater than 90 mm is obtained as a result of the sagittal index, which is the sum of C7 and L3, it is accepted that the score obtained is correlated with increased kyphosis. Baseline
See also
  Status Clinical Trial Phase
Recruiting NCT04914507 - A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering N/A
Not yet recruiting NCT05830825 - PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)
Terminated NCT03676712 - The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial N/A
Terminated NCT04538092 - Complex Spine Enhanced Recovery After Surgery (ERAS) N/A
Completed NCT04669327 - Hip and Knee Moments Normal and With Scoliosis
Completed NCT05033171 - Rod Shape Changing After Scoliosis Correction Surgery N/A
Recruiting NCT04505579 - The Tether™ - Vertebral Body Tethering System Post Approval Study
Recruiting NCT04047225 - POSTOPERATIVE OPIOID-SPARING EFFECT OF INTRAOPERATIVE PAIN MONITORING USING THE ANALGESIA NOCICEPTIVE INDEX (ANI) DURING IDIOPATHIC SCOLIOSIS CORRECTION IN CHILDREN. N/A
Recruiting NCT06086431 - Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery Phase 4
Not yet recruiting NCT05039255 - Acute Effects of Self-correcting Movement on the Balance and Spine of Patients With Scoliosis.
Completed NCT03820895 - Vitamin D Levels in Adolescent Idiopathic Scoliosis
Recruiting NCT05045014 - Evaluation of Vestibular Dysfunction or Visuospatial Perception in Individuals With Idiopathic Scoliosis
Recruiting NCT05011734 - Rapid Postoperative Recovery Pathway in Adolescent Idiopathic Scoliosis.
Active, not recruiting NCT04343170 - Effect of Ultra-short-term Treatment of Patients With Iron Deficiency or Anemia Undergoing Adolescent Scoliosis Correction N/A
Completed NCT04677140 - Hip Related Functional Limitations in Individuals With Idiopathic Scoliosis
Recruiting NCT06093477 - Studying Melatonin and Recovery in Teens N/A
Completed NCT06063447 - Does Adolescent Idıopathic Scoliosis Cause Pelvic Floor Dysfunction?
Recruiting NCT06417944 - The Effect of Three-dimensional Exercise (Schroth Exercise) on Diaphragm Thickness in Adolescent Idiopathic Scoliosis Patients
Recruiting NCT05938959 - Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery Phase 4
Completed NCT05298371 - The Effect of Sitting and Standing Posture on Trunk Rotation in Patients With Idiopathic Scoliosis