Effects of Physical Activity Counseling in Patients With Adolescent Idiopathic Scoliosis

NCT05454800 | Unknown

• 1 other identifier: 2022-FTR9174
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Scoliosis is a three-dimensional deformity of the spine of unknown etiology and is clinically defined as 10° or more lateral curvature of the spine. Although there are different types of scoliosis, the most common type is adolescent idiopathic scoliosis (AIS), which starts at the age of 10. AIS can affect body alignment, spine and soft tissues and cause physical problems such as postural disorder, cosmetic trunk deformity, decreased flexibility of the spinal column, changes in spinal muscle characteristics, and back pain. The aim of our study is to examine the effects of physical activity counseling on physical activity level and posture, perception of deformity and quality of life in patients with AIS.

Conditions

Scoliosis; Adolescent Scoliosis

Outcome Measures

Primary Outcomes (3)

• The Physical Activity Questionnaire for Older Children (PAQ-C) (The change between the baseline value and the post-follow-up value will be evaluated)

  PAQ-C was developed to evaluate the physical activity levels of children aged 8-14 years in the last 7 days. 9 out of 10 items that make up the scale are used to calculate activity scores. The 10th item evaluates whether the child is able to engage in normal activities due to being sick in the previous week or for another reason, but item 10 is not included in the calculation of the activity score. The overall MFAQ score is the average of the scores of 9 items and ranges from 1 to 5. On average, 1 point indicates low physical activity level, and 5 points indicate high physical activity level.

  Baseline, end of weeks 8 and six month follow up

• Physical Activity Questionnaire for Adolescents (PAQ-A) (The change between the baseline value and the post-follow-up value will be evaluated)

  PAQ-A was developed to evaluate the physical activity levels of adolescents aged 14-20 in the last 7 days. 8 out of 9 items that make up the scale are used to calculate activity scores. Item 9 assesses whether the child is able to engage in normal activities due to illness or other reasons in the previous week, but item 9 is not included in the calculation of the activity score. The overall MFAQ score is the average of the scores of 8 items and ranges from 1 to 5. On average, 1 point indicates low physical activity level, and 5 points indicate high physical activity level.

  Baseline, end of weeks 8 and six month follow up

• One-Week Step Count Measurement with Pedometer for Physical Activity Assessment (The change between the baseline value and the post-follow-up value will be evaluated)

  It is one of the objective methods used to evaluate physical activity. It is used to record the number of steps taken. The estimated step length is entered into the device and recorded as a step when the vertical oscillation of the body exceeds a certain threshold value. In our study, the number of steps taken by the participants during a week before and after treatment will be calculated and recorded. Higher scores better outcomes.

  Baseline, end of weeks 8 and six month follow up

Secondary Outcomes (4)

• POsterior Trunk Symmetry Index (POTSI) (The change between the baseline value and the post-follow-up value will be evaluated)

  Baseline, end of weeks 8 and six month follow up

• Anterior Trunk Symmetry Index (ATSI) (The change between the baseline value and the post-follow-up value will be evaluated)

  Baseline, end of weeks 8 and six month follow up

• The Walter Reed Visual Assessment Scale (WRVAS) (The change between the baseline value and the post-follow-up value will be evaluated)

  Baseline, end of weeks 8 and six month follow up

• The Scoliosis Research Society-22 Questionnaire (SRS-22) (The change between the baseline value and the post-follow-up value will be evaluated)

  Baseline, end of weeks 8 and six month follow up

Study Arms (2)

Scoliosis Specific Corrective Exercises and Physical Activity Counseling

EXPERIMENTAL

Individuals with AIS in this group, in accordance with the Schroth classification, individually planned, aimed at correcting and stabilizing the spine in three dimensions, an exercise program will be applied in 45-60 minutes sessions, 2 days a week, for 8 weeks, a total of 16 sessions. In addition to corrective exercises specific to scoliosis, physical activity counseling will also be given.

Other: Scoliosis Specific Corrective Exercises and Physical Activity Counseling

Scoliosis Specific Corrective Exercises

EXPERIMENTAL

Individuals with AIS in this group, in accordance with the Schroth classification, individually planned, aimed at correcting and stabilizing the spine in three dimensions, an exercise program will be applied in 45-60 minutes sessions, 2 days a week, for 8 weeks, a total of 16 sessions.

Other: Scoliosis Specific Corrective Exercises

Interventions

Scoliosis Specific Corrective Exercises and Physical Activity Counseling OTHER

Scoliosis specific corrective exercises and physical activity counseling

Scoliosis Specific Corrective Exercises and Physical Activity Counseling

Scoliosis Specific Corrective Exercises OTHER

Only scoliosis specific corrective exercises

Scoliosis Specific Corrective Exercises

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being diagnosed with Idiopathic Scoliosis by an orthopedic specialist
• Cobb angle determined on anteroposterior radiograph is 10 - 45 degrees

You may not qualify if:

• Having mental problem, rheumatological, neuromuscular, cardiovascular, pulmonary disease
• Any treatment approach for scoliosis in the last six months
• Having any orthopedic problems that may affect their participation in exercise and/or physical activity
• Having a regular exercise habit

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Patias P, Grivas TB, Kaspiris A, Aggouris C, Drakoutos E. A review of the trunk surface metrics used as Scoliosis and other deformities evaluation indices. Scoliosis. 2010 Jun 29;5:12. doi: 10.1186/1748-7161-5-12.

  PMID: 20584340 BACKGROUND

• Stolinski L, Kotwicki T, Czaprowski D, Chowanska J, Suzuki N. Analysis of the Anterior Trunk Symmetry Index (ATSI). Preliminary report. Stud Health Technol Inform. 2012;176:242-6.

  PMID: 22744500 RESULT

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Ayse Zengin Alpozgen, PhD

  Istanbul University-Cerrahpaşa Faculty of Health Sciences

  STUDY CHAIR

• Ugur Ovacık, MSc.

  Istanbul University-Cerrahpaşa, Graduate Education Institute

  STUDY CHAIR

• Elcin Akyurek, MSc.

  Istanbul University-Cerrahpaşa, Graduate Education Institute

  STUDY CHAIR

• Turgut Akgul, MD

  Istanbul University Faculty of Medicine

  STUDY CHAIR

• Pelin Vural, MSc.

  Istanbul University-Cerrahpasa Institute of Postgraduate Education

  STUDY CHAIR

Central Study Contacts

Ayse Zengin Alpözgen, PhD

CONTACT

+905526830479; azengin@istanbul.edu.tr

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: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: July 7, 2022
• Primary Completion: October 1, 2023
• Study Completion: April 1, 2024
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

TU (1)