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临床试验/NCT05326256
NCT05326256已完成不适用

Investigation of Trunk Proprioception and the Efficacy of Different Exercise Training on Trunk Proprioception in Adolescent Idiopathic Scoliosis

Hasan Kalyoncu University2 个研究点 分布在 2 个国家目标入组 21 人开始时间: 2022年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
Change of Cosmetic Deformity Perception according to Individual, Parent and Physiotherapist

研究概览

简要总结

Aims of this clinical research:

  • To investigate trunk proprioception in all three planes in individuals with adolescent idiopathic scoliosis (AIS),
  • To investigate the pelvis orientation sense in all three planes in individuals with adolescent idiopathic scoliosis,
  • To investigate whether trunk proprioception and pelvis orientation sense are improved with Physiotherapy Scoliosis Specific Exercises (PSSE) in AIS,
  • To investigate whether trunk proprioception and pelvis orientation sense are improved with vestibular exercise training to be added to PSSE exercises in AIS,
  • Comparison of the effects of different exercise training on trunk proprioception and pelvis orientation sense in AIS
  • To examine the parameters that may be associated with the improvement of trunk proprioception of different exercise training (health-related quality of life, perception of cosmetic deformity, scoliosis-related clinical features such as Cobb angle, axial trunk rotation, curve type, etc.).

详细描述

This clinical study includes examining trunk proprioception and pelvis orientation in all three planes, pain, flexibility, health-related quality of life, perception of cosmetic deformity, dynamic balance, and the effectiveness of different exercise training in individuals aged 10-18 years with a diagnosis of adolescent idiopathic scoliosis and who have PSSE indication.

As the control group; healthy peers with the same characteristics as the exercise groups will be included and they have a negative result of Adam's forward bending test, they do not have any postural disorders.

As a result of the randomization to be applied to the individuals, they will be divided into two groups: PSSE exercise group and vestibular exercise group (vestibular exercises added to PSSE exercises).

Initial assessments will be given to all individuals. Exercise training groups will participate in a 45-minute exercise session with the supervisor, twice a week for 12 weeks. Before exercise training, individuals and their parents will be informed about education and daily life activities.

Apart from the exercises performed under the supervision of a physiotherapist, individuals will be given a home exercise program, and the family and the individual will be asked to keep a diary to evaluate their compliance with the exercise, and the exercise compliance will be evaluated with a phone call every week.

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
Double (Participant, Outcomes Assessor)

盲法说明

Participants in the training groups and the statistical assessor will not be informed about which group the individuals belong to.

入排标准

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

入选标准

  • Diagnosed with adolescent idiopathic scoliosis,
  • Aged 10-18,
  • Have Physiotherapy Scoliosis Specific Exercises (PSSE) indications,
  • Individuals and her/his parents volunteered to participate in the study.

排除标准

  • Any contraindication that will prevent the individual from participating to exercise training,
  • Have had spinal surgery before,
  • Have any mental problems,
  • The fact that scoliosis is not idiopathic but has arisen for different reasons (neurological, congenital, etc.),
  • The apex of the curve is thoracal-6 vertebrae and above,
  • Any neurological, psychiatric, muscular, rheumatic, renal, cardiovascular, pulmonary, tumoral, or orthopedic disease.

结局指标

主要结局

Change of Cosmetic Deformity Perception according to Individual, Parent and Physiotherapist

时间窗: Baseline, after the 12 weeks of exercise training

Perception of cosmetic deformity assessment with Turkish version of The Spinal Appearance Questionnaire (SAQ)

Change of Trunk Proprioception

时间窗: Baseline, after the 12 weeks of exercise training

Thoracic position sense is measured by active angle reproduction using GyKo (Microgate, Bolzano, Italy) inertial system. The system component is located on the trunk at the level of C7-T1 vertebrae. The individual to be measured is standing, for example, the individual to flexion the trunk to 30 degrees and is shown to target angle. Then, the individual is asked to close his eyes and come to the target angle actively. The measurement is repeated 3 times. All data are read from the screen.

Change of Pelvis Orientation Sense

时间窗: Baseline, after the 12 weeks of exercise training

Pelvis orientation sense is measured by active angle reproduction using GyKo (Microgate, Bolzano, Italy) inertial system. The system component is located on the lumbar area at the level of the S1 vertebrae. The individual to be measured is standing, performs the anterior-posterior pelvic tilt motion in her/his pelvis, and is shown to target angle. Then, the individual is asked to close his eyes and come to the target angle actively. The measurement is repeated 3 times. All data are read from the screen.

Change of Dynamic balance, spatial orientation

时间窗: Baseline, after the 12 weeks of exercise training

Assement of dynamic balance with Fukuda-Utenberger stepping test

Change of Cosmetic Deformity Perception

时间窗: Baseline, after the 12 weeks of exercise training

Perception of cosmetic deformity assessment with Walter Reed Visual Evaluation Scale and Turkish version of The Spinal Appearance Questionnaire (SAQ)

Change of Health-Related Quality of Life

时间窗: Baseline, after the 12 weeks of exercise training

Health-Related Quality of Life Assessment with Turkish version of Scoliosis Research Society-22 (SRS-22) Questionnaire

Change of Body Asymmetry

时间窗: Baseline, after the 12 weeks of exercise training

Body asymmetry assessment with POTSI (Postural Trunk Symmetry Index)

次要结局

  • Change of Pain(Baseline, after the 12 weeks of exercise training)
  • Enroll of the clinical features of scoliosis(Baseline, after the 12 weeks of exercise training)
  • Change of Angle of Trunk Rotation(Baseline, after the 12 weeks of exercise training)
  • Enroll of the Cobb Angle(Baseline, after the 12 weeks of exercise training)
  • Change of Flexibility(Baseline, after the 12 weeks of exercise training)
  • Evaluation of exercise training compliance(Once a week for 12 weeks)
  • Enroll of the Risser sign(Baseline, after the 12 weeks of exercise training)

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Karatel

Principal Investigator

Hasan Kalyoncu University

研究点 (2)

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