Clinical trial NCT05454800: Effects of Physical Activity Counseling in Patients With Adolescent Idiopathic Scoliosis
Official title: Effects of Physical Activity Counseling in Addition to Scoliosis-Specific Corrective Exercises in Patients With Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scoliosis
Adolescent Scoliosis
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 27
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: AIS is the most common spinal deformity seen by primary care physicians, pediatricians, and spinal surgeons. The primary goal in the conservative treatment of scoliosis in adolescents is to prevent the progression of the curvature and secondary problems associated with spinal deformity and ultimately to eliminate the need for surgery. For this reason, scoliosis-specific corrective exercise therapy given by a physiotherapist is recommended for patients with AIS. However, while this treatment is effective to the gold standard on spine and posture, its effect on physical activity is not known exactly. The aim of this study is to examine the effect of physical activity counseling on physical activity level and posture, perception of deformity and quality of life in individuals with AIS who are given physical activity counseling in addition to scoliosis-specific corrective exercises. Individuals with AIS in both groups, in accordance with the Schroth classification, individually planned exercise program aimed at correcting and stabilizing the spine in three dimensions, in the form of 45-60 minutes sessions, 2 days a week for 8 weeks, a total of 16 sessions. Group 1 will be given physical activity counseling as well as scoliosis-specific corrective exercises. Physical activity counseling will be done face-to-face, and one-on-one interviews will be provided with each participant. Each meeting will last approximately 20-30 minutes and individuals will be encouraged to participate in more physical activity by providing alternative solutions on their physical activity habits, what they like to do or how they can access activities.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Physical Activity Questionnaire for Older Children (PAQ-C) (The change between the baseline value and the post-follow-up value will be evaluated)
timeFrame: Baseline, end of weeks 8 and six month follow up
measure: Physical Activity Questionnaire for Adolescents (PAQ-A) (The change between the baseline value and the post-follow-up value will be evaluated)
timeFrame: Baseline, end of weeks 8 and six month follow up
measure: 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)
timeFrame: Baseline, end of weeks 8 and six month follow up
Secondary outcomes:
measure: POsterior Trunk Symmetry Index (POTSI) (The change between the baseline value and the post-follow-up value will be evaluated)
timeFrame: Baseline, end of weeks 8 and six month follow up
measure: Anterior Trunk Symmetry Index (ATSI) (The change between the baseline value and the post-follow-up value will be evaluated)
timeFrame: Baseline, end of weeks 8 and six month follow up
measure: The Walter Reed Visual Assessment Scale (WRVAS) (The change between the baseline value and the post-follow-up value will be evaluated)
timeFrame: Baseline, end of weeks 8 and six month follow up
measure: The Scoliosis Research Society-22 Questionnaire (SRS-22) (The change between the baseline value and the post-follow-up value will be evaluated)
timeFrame: Baseline, end of weeks 8 and six month follow up
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University-Cerrahpaşa Faculty of Health Sciences
name: Ayse Zengin Alpozgen, PhD
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpaşa, Graduate Education Institute
name: Ugur Ovacık, MSc.
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpaşa, Graduate Education Institute
name: Elcin Akyurek, MSc.
role: STUDY_CHAIR
affiliation: Istanbul University Faculty of Medicine
name: Turgut Akgul, MD
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpasa Institute of Postgraduate Education
name: Pelin Vural, MSc.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.