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临床试验/NCT07500883
NCT07500883招募中不适用

Effects of Integrating Basic Body Awareness Therapy Into Scoliosis-Specific Exercises on Body Awareness, Quality of Life, and Scoliosis-Related Outcomes in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial

Gözde Yagci (Gür)1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Body Awareness Questionnaire (BAQ)

研究概览

简要总结

The goal of this randomised clinical trial is to evaluate whether adding Basic Body Awareness Therapy (BBAT) to scoliosis-specific exercises can improve body awareness, quality of life and scoliosis-speficic outcomes in adolescents aged 10-17 years with adolescent idiopathic scoliosis (AIS). The main questions it aims to answer are:

Does the addition of BBAT to scoliosis-specific exercises lead to greater improvements in body awareness compared to scoliosis-specific exercises alone? Does adding BBAT improve trunk proprioception, scoliosis-related parameters, and health-related quality of life in adolescents with AIS?

H1: Adolescents with idiopathic scoliosis who receive Basic Body Awareness Therapy in addition to scoliosis-specific exercises will demonstrate greater improvements in body awareness compared to those receiving scoliosis-specific exercises alone.

H2: Adolescents receiving Basic Body Awareness Therapy in addition to scoliosis-specific exercises will demonstrate greater improvements in scoliosis-related clinical parameters compared to those receiving scoliosis-specific exercises alone.

H3: Adolescents receiving Basic Body Awareness Therapy in addition to scoliosis-specific exercises will demonstrate greater improvements in both general and scoliosis-specific quality of life compared to those receiving scoliosis-specific exercises alone.

详细描述

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that may affect not only spinal alignment but also postural control and body perception. Recent evidence suggests that, beyond structural deformity, alterations in sensory integration and body awareness may contribute to postural asymmetry in individuals with AIS. These findings highlight the importance of addressing both structural and perceptual components in rehabilitation.

Physiotherapeutic scoliosis-specific exercises (PSSE) are widely used in the conservative management of AIS and aim to improve spinal alignment through active self-correction and functional stabilization. While PSSE has demonstrated positive effects on scoliosis-related clinical outcomes, its effects on perceptual aspects such as body awareness remain less explored. Therefore, integrating interventions that specifically target body awareness may enhance rehabilitation outcomes.

Basic Body Awareness Therapy (BBAT) is a movement-based approach that focuses on posture, movement quality, breathing, and awareness of bodily sensations. By promoting conscious perception of body alignment and movement, BBAT may support improvements in postural control and functional organization in individuals with AIS. For this reason, BBAT was incorporated as a complementary intervention alongside PSSE.

This study is designed as a randomized controlled trial to investigate the effects of adding BBAT to a PSSE-based rehabilitation program. Participants will be randomly assigned to either a control group receiving PSSE alone or an intervention group receiving PSSE combined with BBAT. Both groups will participate in supervised sessions once per week for 6 months and perform home-based exercises on the remaining days.

Outcome measures will include body awareness, health-related quality of life, and scoliosis-specific clinical parameters. Assessments will be conducted at baseline and after 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

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

  • Diagnosed of adolescent idiopathic scoliosis
  • Age between 10 and 17 years
  • Cobb angle ≥15°
  • No previous or concurrent scoliosis treatment
  • Risser sign between 0 and 4

排除标准

  • Evidence of congenital scoliosis or other spinal deformities (e.g., hyperkyphosis, pectus deformities)
  • Diagnosis of neuromuscular, rheumatologic, neurological, cardiovascular, pulmonary disorders
  • Regular participation in sports
  • History of spinal orthosis use or scoliosis surgery.

结局指标

主要结局

Body Awareness Questionnaire (BAQ)

时间窗: 6 months

The Body Awareness Questionnaire (BAQ) is a self-reported instrument originally developed by Shields et al. in 1989. The Turkish version has been shown to be valid and reliable in healthy individuals. The questionnaire assesses awareness of bodily processes, including sensitivity to bodily responses, prediction of bodily reactions, sleep-wake cycles, and the onset of illness. The BAQ consists of 18 items grouped into four subdomains and is rated on a 7-point Likert scale, ranging from 1 ("not at all true for me") to 7 ("completely true for me"). Total scores are calculated by summing item responses, with higher scores indicating greater body awareness.

Awareness Body Chart (ABC)

时间窗: 6 months

The Awareness Body Chart (ABC) is a simple, easy-to-use, and low-cost instrument developed by Danner et al. in 2017. It demonstrates high internal consistency and test-retest reliability. The chart consists of schematic anterior and posterior drawings of the human body, divided into 51 regions and 14 body parts based on anatomical structures. Participants are asked to perceive each body region and indicate their level of awareness by coloring the corresponding areas according to predefined categories. Higher scores reflect greater body awareness. The ABC also includes a pain intensity scale ranging from 0 (no pain) to 100 (unbearable pain), and participants are instructed to mark painful areas on the chart.

The Pediatric Quality of Life Inventory (PedsQL)

时间窗: 6 months

The Pediatric Quality of Life Inventory (PedsQL) is used to assess general health-related quality of life from both the child's and the parent's perspectives. It evaluates the impact of disease and treatment on physical, emotional, social, and school functioning.The scale consists of 23 items rated on a Likert-type scale, and higher total scores indicate better quality of life. The Turkish version of the PedsQL has demonstrated acceptable validity and reliability. Age-appropriate versions of the questionnaire are used for children aged 8-12 and 13-18 years, with parallel forms containing the same items but adapted language for each age group. Parent-proxy versions are also administered to obtain the parent's perspective.

The Japanese Scoliosis Questionnaire-27 (JSQ-27)

时间窗: 6 months

The Japanese Scoliosis Questionnaire-27 (JSQ-27) is used to assess scoliosis-specific quality of life in individuals with adolescent idiopathic scoliosis. It evaluates a broad range of domains, including pain, discomfort while wearing clothes, concerns about physical appearance, anxiety, and difficulties in daily activities. The questionnaire consists of 27 items scored on a 5-point scale ranging from 0 ("none") to 4 ("severe"). Total scores are calculated by summing item responses, with higher scores indicating worse scoliosis-specific quality of life. The JSQ-27 has been validated in individuals with adolescent idiopathic scoliosis, and the Turkish version has demonstrated good validity and internal consistency.

次要结局

  • Curve magnitude- Cobb angle method(6 months)
  • Axial Trunk Rotation (ATR)(6 months)
  • Posterior Trunk Symmetry Index(6 months)
  • Anterior Trunk Symmetry Index(6 months)
  • Exercise Adherence(6 months)

研究者

发起方
Gözde Yagci (Gür)
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gözde Yagci (Gür)

Professor

Hacettepe University

研究点 (1)

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