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临床试验/NCT07285551
NCT07285551已完成不适用

Impact of Specific Physiotherapy and Whole-Body Vibration on Spinal Parameters in Patients With Adolescent Idiopathic Scoliosis

Gdansk University of Physical Education and Sport1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年2月15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
50
试验地点
1
主要终点
Measurements of the sagittal curvature of the spine

研究概览

简要总结

The aim of this study is to assess how physiotherapy based on the Rigo Concept, combined with WBV, affects sagittal spinal curvatures, the angle of trunk rotation (ATR), and trunk symmetry in girls with AIS.

Participants undergo a 5-day individualized physiotherapy program. The exercises follow the four general principles of the Rigo Concept: three-dimensional postural correction, expansion technique, muscle activation, and integration. Therapy is delivered for 3 hours per day, with three 15-minute breaks. Additionally, participants in the Rigo Concept with WBV group perform exercises in a standing position using two poles while exposed to WBV on a Galileo Med 35 platform (Novotec Medical GmbH, Pforzheim, Germany) at a frequency of 25 Hz, with a peak-to-peak displacement of 2 mm. Each session includes three 3-minute bouts of vibration, with 3-minute rests between them. During WBV, participants perform exercises according to the principles of the Rigo Concept.

研究设计

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

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of the adolescent idiopathic scoliosis
  • Written consent of a medical doctor for participation

排除标准

  • thrombosis
  • body implants
  • musculoskeletal inflammation
  • arthropathy
  • tendonitis
  • disc herniation
  • recent fractures
  • kidney stones
  • recent scars
  • rheumatoid arthritis
  • neuropathy
  • previous spinal surgery
  • injuries in the spine during the past six months
  • injuries in the lower limbs during the past six months
  • pain in the spine during the past six months
  • pain in the lower limbs during the past six months
  • for group with WBV additionally discomfort or felt unwell during vibration exposure

研究组 & 干预措施

Rigo Concept group

Active Comparator

Physiotherapy/exercieses according to the Rigo Concept, 5 days, 3 hour per day

干预措施: Rigo Concept group (Procedure)

Rigo Concept with whole-body vibration group

Experimental

Physiotherapy/exercises according to the Rigo Concept combined with whole-body vibration, 5 days, 3 hour per day, supplemented with 3 x 3 minutes of WBV, frequency 25 Hz, amplitude 2 mm

干预措施: Rigo Concept with whole-body vibration group (Procedure)

结局指标

主要结局

Measurements of the sagittal curvature of the spine

时间窗: Before the first physiotherapy session and three hours after the last physiotherapy session

The examination of spinal curvatures (degrees) in the sagittal plane is conducted using a Baseline digital inclinometer (MVS in Motion, Belgium). Measurements are taken in a relaxed standing position. The assessment includes evaluation of thoracic kyphosis (upper and lower parts), lumbar lordosis, and sacral slope. The procedure is as follows: 1) Thoracic kyphosis - the inclinometer is zeroed at the thoracolumbar junction (Th12-L1), and the value is recorded at the cervicothoracic junction (C7-Th1); 2) Lumbar lordosis - the inclinometer is zeroed at the lumbosacral junction (L5-S1), and the value is recorded at the thoracolumbar junction (Th12-L1); 3) Sacral slope - the inclinometer is zeroed in the horizontal position, and the value is recorded at the lumbosacral junction (L5-S1).

Measurements of the trunk symmetry

时间窗: Before the first physiotherapy session and three hours after the last physiotherapy session

For postural alignment (centimeters), the physician positions a plumb line at the level of the occipital prominence. Measurements are performed using a rigid millimeter ruler and are rounded to the nearest 0 or 5 mm, assessing the distance from the plumb line to the gluteal cleft. For the assessment of scapular height asymmetry, the inferior angles of the scapulae are marked bilaterally. A rigid ruler is placed across these points, and a scoliometer is positioned on the ruler to record the angle of inclination (degrees). The distances from the inferior angles of the scapulae to the line of spinous processes are measured on both the left and right sides using a rigid ruler, and the differences (centimeters) are then calculated.

Measurements of the angle of trunk rotation

时间窗: Before the first physiotherapy session and three hours after the last physiotherapy session

The measurements of the angle of trunk rotation in the transverse plane are conducted using a Baseline scoliometer (MoVeS, Poland). The angle of trunk rotation is assessed during the Adams forward bend test. The participant stands in a relaxed upright position and is instructed to keep their hands together and slowly bend forward, aiming their hands toward the center of support. The examiner records the angle (degrees) and direction (left/right) of trunk rotation at the proximal and main thoracic spine, thoracolumbar region, lumbar spine, and at the level of the posterior superior iliac spine.

次要结局

未报告次要终点

研究者

发起方
Gdansk University of Physical Education and Sport
申办方类型
Other
责任方
Sponsor

研究点 (1)

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