The Effects of Core Stability Training in Children With Adolescent Idiopathic Scoliosis

NCT05056363 | Completed DMC

• 1 other identifier: IUFGokdemir01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescent idiopathic scoliosis (AIS) is a three-dimensional structural deformity of the spine in which lateral flexion and axial rotation are seen in vertebrae with a Cobb (method for measuring spinal curvature) angle of 10° and above. AIS is the most common type of scoliosis and it occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates. Children with AIS have cosmetic effects, decrease in functional capacity, muscle weakness in certain parts of the body, decrease in quality of life and posture disorders. Lack of core stability might be causing these problems. Core stability training may have a positive effect for these problems experienced by children with AIS. Pathologies that cause the disease may originate from the nervous system and musculoskeletal system. In this study, the investigators will evaluate these systems objectively with EMG biofeedback and Isokinetic Testing. The aim of this study is to show the effect of core stability training on various problems (as we mentioned before) caused by the disease. In addition, the investigators of this study hope to contribute to the literature(with objective evaluations) about the pathological background and treatment of this challenging disease which the cause is unknown.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Isokinetic Testing; EMG Biofeedback; Core Stability

Outcome Measures

Primary Outcomes (4)

• Muscle Strength of Trunk Flexion / Extension

  Measurement of isokinetic and isometric muscle strength with Biodex System 3Pro Multijoint System Isokinetic Dynamometer.

  8 week

• Cobb Angle

  Cobb Angle measurement with AP Radiography

  8 week

• Muscle Strength

  Evaluation of the muscle strength with using a non-invasive Myomed 932 EMG-biofeedback device (Enraf-Nonius, The Netherlands)

  8 week

• Muscle Electromyographic Activity

  Measurement of the surface electromyographic activity with using a non-invasive Myomed 932 EMG-biofeedback device (Enraf-Nonius, The Netherlands)

  8 week

Secondary Outcomes (4)

• Trunk Rotation

  8 week

• Patients Quality of Life

  8 week

• Cosmetic Deformity Evaluation

  8 week

• Flexibility Measurement

  8 week

Study Arms (2)

Control Group

ACTIVE COMPARATOR

The control group will be given home based traditional scoliosis exercise training for 8 weeks, 5 days a week for 45 minutes.

Other: Home Based Traditional Scoliosis Exercises

Training Group

EXPERIMENTAL

In addition to conventional home based traditional scoliosis exercises, patients in this group will also receive core stabilization exercise training for 45 minutes, 5 times in a week for 8 weeks. Every two sessions will be supervised in a clinic per week.

Other: Home Based Traditional Scoliosis Exercises; Other: Core Stability Training

Interventions

Home Based Traditional Scoliosis Exercises OTHER

Patients in this group will receive posture exercises, strengthening exercises, diaphragmatic breathing exercises and stretching exercises.

Control Group; Training Group

Core Stability Training OTHER

Patients in this group will receive traditional scoliosis exercises. In addition, the training group will receive core stabilization exercises for multifidus, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, iliopsoas, gluteus maximus, and pelvic floor muscles.

Training Group

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with AIS between the ages of 10-20
• Cobb angle is between 15-40 degrees
• The child's and family's consent to participate in the study
• The child does not receive any other treatment that will affect his scoliosis.

You may not qualify if:

• Surgical operation in the last 3 months
• Presence of an orthopedic, neurological, systemic disease that will prevent him from exercising
• Having mental, communicative and behavioral disorders that may cause problems understanding commands and questions or performing exercises
• Exercising 3 or more days a week.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Study Officials

• Fuat Gökdemir

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 24, 2021
• Study Start: October 5, 2021
• Primary Completion: March 10, 2022
• Study Completion: March 25, 2022
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

TU (1)