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临床试验/NCT05454800
NCT05454800Unknown不适用

Effects of Physical Activity Counseling in Addition to Scoliosis-Specific Corrective Exercises in Patients With Adolescent Idiopathic Scoliosis

Istanbul University - Cerrahpasa (IUC)2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2022年7月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
27
试验地点
2
主要终点
Physical Activity Questionnaire for Adolescents (PAQ-A) (The change between the baseline value and the post-follow-up value will be evaluated)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

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

时间窗: Baseline, end of weeks 8 and six month follow up

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.

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

时间窗: Baseline, end of weeks 8 and six month follow up

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.

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)

时间窗: Baseline, end of weeks 8 and six month follow up

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.

次要结局

  • 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)
  • 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)
  • 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)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pelin Vural

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

研究点 (2)

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