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临床试验/NCT07425886
NCT07425886已完成不适用

Results of a 6-month Therapeutic Program Regarding the Angle of Trunk Rotation in Girls Aged 8-11: a Randomized Trial

Wioleta Chwalewska1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2023年1月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
Angle of Trunk Rotation (ATR)

研究概览

简要总结

The primary assumption of this study is to evaluate the impact of individual and group corrective therapy on changes in body posture in the transverse plane in girls aged 8-11 years diagnosed with posture disorders. The aim of the study is to assess the effectiveness of a 6-month intervention consisting of individual physiotherapy conducted in accordance with the principles of the Functional Individual Therapy of Scoliosis (FITS) method and group corrective exercises, compared with observation only.

The study will enable a detailed analysis of changes in the angle of trunk rotation and selected parameters of spinal rotation in the transverse plane in children participating in the intervention. The results obtained may contribute to the evaluation of the clinical usefulness of individual and group physiotherapy programs in the correction of posture disorders and in the early prevention of scoliosis in the pediatric population.

详细描述

The study was conducted in a population of girls aged 8-11 years identified through a school-based screening program for posture disorders. Following the informed consent procedures, 66 girls meeting all eligibility criteria were enrolled in the intervention phase.

Participants were assigned to one of three groups:

  1. an individual therapy group undergoing physiotherapy in accordance with the principles of Functional Individual Therapy of Scoliosis (FITS),
  2. a group therapy group participating in group corrective exercises, and
  3. a control group remaining under observation without therapeutic intervention.

Posture assessment was performed before and after a 6-month intervention period. The angle of trunk rotation was measured using a scoliometer. A three-dimensional, non-invasive assessment of body posture and spinal alignment in the transverse plane was conducted using the DIERS Formetric 4D system. The evaluated parameters included trunk surface rotation, vertebral rotation, and selected rotational parameters of the thoracic and lumbar spine segments.

The individual FITS therapy was conducted according to standardized methodological principles and was tailored to the specific postural characteristics of each participant. Group corrective exercises were performed according to an established corrective exercise program appropriate for children with posture disorders. The observation group did not participate in any structured therapeutic intervention during the study period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • female gender
  • age 8-11 years
  • before or up to six months after the onset of the first menstruation
  • ATR 3-6 degrees
  • no diagnosed orthopaedic, neurological or viral diseases
  • written consent of parents and/or legal guardians to participate in the project

排除标准

  • ATR below 3 and/or above 6 degrees
  • visible structural abnormalities
  • neurological, neuromuscular or cardiovascular diseases
  • congenital defects
  • scoliosis
  • Scheuermann's disease
  • diagnosed anatomical leg length discrepancy of less than 2.5 cm
  • poor psychophysical condition
  • elevated body temperature
  • back or lower limb surgery
  • spina bifida
  • intellectual disability
  • genetic conditions
  • lack of written consent for testing.

研究组 & 干预措施

Group corrective gymnastics

Experimental

Girls aged 8-11 with ATR 3-6 degrees (5-6 people) (n=21).

干预措施: Group corrective gymnastics (Diagnostic Test)

Indywidual Therapy: FITS method

Experimental

Girls aged 8-11 with ATR 3-6 degrees (n=22).

干预措施: Indywidual Therapy: FITS method (Diagnostic Test)

Observational group

No Intervention

Girls aged 8-11 with ATR 3-6 degrees (n=22).

结局指标

主要结局

Angle of Trunk Rotation (ATR)

时间窗: 6 month

Angle of trunk rotation measured in degrees using a scoliometer during Adam's forward bend test.

Surface Rotation Parameters (DIERS Formetric 3D)

时间窗: 6 months

surface rotation assessed using the DIERS Formetric 3D system, including surface rotation (degrees), root mean square of back surface rotation (degrees), and maximum vertebral rotation (degrees) in the thoracic (Th1-Th4, Th5-Th12) and lumbar (L1-L5) spine segments.

次要结局

未报告次要终点

研究者

发起方
Wioleta Chwalewska
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wioleta Chwalewska

Principal Investigator

Józef Piłsudski University of Physical Education

研究点 (1)

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