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Effects of Physical Activity Counseling in Patients With Adolescent Idiopathic Scoliosis

Primary Purpose

Scoliosis, Adolescent Scoliosis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Scoliosis Specific Corrective Exercises and Physical Activity Counseling
Scoliosis Specific Corrective Exercises
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University-CerrahpasaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Scoliosis Specific Corrective Exercises and Physical Activity Counseling

Scoliosis Specific Corrective Exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

POsterior Trunk Symmetry Index (POTSI) (The change between the baseline value and the post-follow-up value will be evaluated)
POTSI is defined as the sum of six indices, three frontal plane asymmetry indices and three frontal plane height difference indices, in the patient's anterior and posterior photographs. Calculation is made by placing indices into the formula. While zero represents full symmetry, as the score increases, the asymmetry also increases (Stolinski et al. 2012; Patias et al. 2010). In our study, "SCODIAC" (SCOliotic DIAgnostiCs) computer program will be used for PGAI and AGAI calculations. While zero represents complete symmetry, as the score increases, so does the asymmetry.
Anterior Trunk Symmetry Index (ATSI) (The change between the baseline value and the post-follow-up value will be evaluated)
ATSI (PGAI) is defined as the sum of six indices, three frontal plane asymmetry indices and three frontal plane height difference indices, in the patient's anterior and posterior photographs. Calculation is made by placing indices into the formula. While zero represents full symmetry, as the score increases, the asymmetry also increases (Stolinski et al. 2012; Patias et al. 2010). In our study, "SCODIAC" (SCOliotic DIAgnostiCs) computer program will be used for PGAI and AGAI calculations. While zero represents complete symmetry, as the score increases, so does the asymmetry.
The Walter Reed Visual Assessment Scale (WRVAS) (The change between the baseline value and the post-follow-up value will be evaluated)
WRVAS is an easy-to-use and scoring scale that allows to understand the visual change caused by scoliosis. In WRVAS, which correlates with the degree of curvature and has high internal consistency, treatment results are evaluated under seven headings. Each deformity is scored from 1 to 5 on the scale. In our study, this scale will be filled by the physiotherapist and the individual with AIS, and the difference (dWRVAS) between the WRVAS scores of the physiotherapist and the individual with AIS will be noted. The decrease in the difference will be evaluated as an improvement in the perception of deformity. High scores indicate increased deformity.
The Scoliosis Research Society-22 Questionnaire (SRS-22) (The change between the baseline value and the post-follow-up value will be evaluated)
SRS-22 is a questionnaire designed by the Scoliosis Research Society (SRS) specifically for patients with spinal deformity. This questionnaire, which consists of 5 main titles, includes questions about pain, body image, function, mental health and satisfaction with treatment. The score for each item ranges from zero (worst) to five (best). Scores in the sections can be obtained separately by dividing the score received from each section by the number of questions in the relevant section, and the total score can be obtained by adding the scores obtained from all questions and dividing them by the total number of questions. As a result of scoring, a high score indicates an increase in quality of life.

Full Information

First Posted
July 7, 2022
Last Updated
July 17, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05454800
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis, Adolescent Scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Scoliosis Specific Corrective Exercises and Physical Activity Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Scoliosis Specific Corrective Exercises
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Scoliosis Specific Corrective Exercises and Physical Activity Counseling
Intervention Description
Scoliosis specific corrective exercises and physical activity counseling
Intervention Type
Other
Intervention Name(s)
Scoliosis Specific Corrective Exercises
Intervention Description
Only scoliosis specific corrective exercises
Primary Outcome Measure Information:
Title
The Physical Activity Questionnaire for Older Children (PAQ-C) (The change between the baseline value and the post-follow-up value will be evaluated)
Description
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.
Time Frame
Baseline, end of weeks 8 and six month follow up
Title
Physical Activity Questionnaire for Adolescents (PAQ-A) (The change between the baseline value and the post-follow-up value will be evaluated)
Description
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.
Time Frame
Baseline, end of weeks 8 and six month follow up
Title
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)
Description
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.
Time Frame
Baseline, end of weeks 8 and six month follow up
Secondary Outcome Measure Information:
Title
POsterior Trunk Symmetry Index (POTSI) (The change between the baseline value and the post-follow-up value will be evaluated)
Description
POTSI is defined as the sum of six indices, three frontal plane asymmetry indices and three frontal plane height difference indices, in the patient's anterior and posterior photographs. Calculation is made by placing indices into the formula. While zero represents full symmetry, as the score increases, the asymmetry also increases (Stolinski et al. 2012; Patias et al. 2010). In our study, "SCODIAC" (SCOliotic DIAgnostiCs) computer program will be used for PGAI and AGAI calculations. While zero represents complete symmetry, as the score increases, so does the asymmetry.
Time Frame
Baseline, end of weeks 8 and six month follow up
Title
Anterior Trunk Symmetry Index (ATSI) (The change between the baseline value and the post-follow-up value will be evaluated)
Description
ATSI (PGAI) is defined as the sum of six indices, three frontal plane asymmetry indices and three frontal plane height difference indices, in the patient's anterior and posterior photographs. Calculation is made by placing indices into the formula. While zero represents full symmetry, as the score increases, the asymmetry also increases (Stolinski et al. 2012; Patias et al. 2010). In our study, "SCODIAC" (SCOliotic DIAgnostiCs) computer program will be used for PGAI and AGAI calculations. While zero represents complete symmetry, as the score increases, so does the asymmetry.
Time Frame
Baseline, end of weeks 8 and six month follow up
Title
The Walter Reed Visual Assessment Scale (WRVAS) (The change between the baseline value and the post-follow-up value will be evaluated)
Description
WRVAS is an easy-to-use and scoring scale that allows to understand the visual change caused by scoliosis. In WRVAS, which correlates with the degree of curvature and has high internal consistency, treatment results are evaluated under seven headings. Each deformity is scored from 1 to 5 on the scale. In our study, this scale will be filled by the physiotherapist and the individual with AIS, and the difference (dWRVAS) between the WRVAS scores of the physiotherapist and the individual with AIS will be noted. The decrease in the difference will be evaluated as an improvement in the perception of deformity. High scores indicate increased deformity.
Time Frame
Baseline, end of weeks 8 and six month follow up
Title
The Scoliosis Research Society-22 Questionnaire (SRS-22) (The change between the baseline value and the post-follow-up value will be evaluated)
Description
SRS-22 is a questionnaire designed by the Scoliosis Research Society (SRS) specifically for patients with spinal deformity. This questionnaire, which consists of 5 main titles, includes questions about pain, body image, function, mental health and satisfaction with treatment. The score for each item ranges from zero (worst) to five (best). Scores in the sections can be obtained separately by dividing the score received from each section by the number of questions in the relevant section, and the total score can be obtained by adding the scores obtained from all questions and dividing them by the total number of questions. As a result of scoring, a high score indicates an increase in quality of life.
Time Frame
Baseline, end of weeks 8 and six month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayse Zengin Alpözgen, PhD
Phone
+905526830479
Email
azengin@istanbul.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayse Zengin Alpozgen, PhD
Organizational Affiliation
Istanbul University-Cerrahpaşa Faculty of Health Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ugur Ovacık, MSc.
Organizational Affiliation
Istanbul University-Cerrahpaşa, Graduate Education Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elcin Akyurek, MSc.
Organizational Affiliation
Istanbul University-Cerrahpaşa, Graduate Education Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Turgut Akgul, MD
Organizational Affiliation
Istanbul University Faculty of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pelin Vural, MSc.
Organizational Affiliation
Istanbul University-Cerrahpasa Institute of Postgraduate Education
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pelin Vural
Phone
+905344245350
Email
pelinvural7@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
20584340
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.
Results Reference
background
PubMed Identifier
22744500
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.
Results Reference
result

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Effects of Physical Activity Counseling in Patients With Adolescent Idiopathic Scoliosis

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