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临床试验/NCT05861856
NCT05861856已完成不适用

Comparison of the Efficiency of Manual Therapy and Virtual Reality Supported Core Stabilization Exercises in Patient With Adolescent Idiopathic Scoliosis

Hacettepe University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年7月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Angle of Trunk Rotation

研究概览

简要总结

Adolescent Idiopathic Scoliosis is a three-dimensional deformity of the trunk and spine of unknown cause seen in adolescents. There are various conservative treatment methods to treat scoliosis. Manual therapy and exercises are a few of these treatments. There are studies showing that manual therapy reduces the severity of curvature, increases range of motion, modulates tissue/muscle extensibility, improves soft tissue movement limitation, relieves pain, and increases psychological well-being in scoliosis patients. In order to treat scoliosis, there are various exercise applications that are applied specifically to scoliosis, from physiotherapy applications. Core stabilization is one of the exercise methods that aim to keep the spine in the center.

Virtual reality, on the other hand, is a three-dimensional simulation model that gives its participants the feeling of reality and allows mutual communication with a dynamic environment created by computers. Virtual reality is a method that provides the opportunity to work with task-based techniques by creating stimulating and entertaining environments, using people's interests and motivations. In a study, it was stated that two of the scoliosis-specific exercises were done through video-assisted games, but they stated that there was no difference because the number of exercises was low. Therefore, in this study, it was aimed to apply core stabilization exercises to scoliosis patients with virtual reality application and to investigate their effects on recovery in patients. In addition, it is planned to investigate whether the severity of the curvature in patients decreases further and whether it has an effect on other healing parameters by using the virtual reality treatment application together with manual treatment.

详细描述

Male and female volunteer patients who were diagnosed with "Adolescent Idiopathic Scoliosis" and referred to physical therapy and met the inclusion criteria will be included in the study. Patients whose families and themselves agreed to participate voluntarily in this study will be randomly divided into three groups and included in the study. Virtual reality supported core stabilization exercises (stability enhancing exercises for the muscles around the spine), manual therapy (mobilization for the spine, mobilization and relaxation methods for the soft tissues around the spine) techniques for the second group, and both virtual reality supported core stabilization exercises and exercises for the third group were given to the third group. Manual therapy techniques will also be applied. The treatment program was planned as a total of 16 sessions, 2 days a week for 8 weeks. This study was planned as single-blind for the purpose of impartiality of the evaluation.

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 (Care Provider, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with AIS
  • Age 10-16 years
  • Cobb angle was between 10° and 25
  • Risser sing did not exceed 4
  • Informed consent forms were signed by the parents and children

排除标准

  • Used brace,
  • Had previous spinal surgery, inferior limb length difference,
  • Could not exercise due to another injury/diagnosis,
  • Had neuromuscular, psychiatric, cardiovascular, respiratory insufficiency and mental disability

结局指标

主要结局

Angle of Trunk Rotation

时间窗: Change from pretreatment and 8 weeks after treatment.

It assessed with a Bunnell scoliometer is a type of inclinometer that measures the asymmetry of the degree of axial rotation on both sides of the body. Assessment is in a standing, forward-bending position bent-over position (arms dangling, palms pressed together) with the pelvis horizontal, and subject standing on a foot template

Cobb angle

时间窗: Change from pretreatment and 8 weeks after treatment.

The most accepted way of scoliosis evaluation is Cobb angle measurement performed on frontal plane x-ray. The Cobb angle is the curvature of the spine, and measuring it is essential for determining the severity of scoliosis, selecting the best course of action, and monitoring the progression or regression of cases following treatment. The Cobb angle measure as the vertically intersecting angle after determining the vertebrae above the apex and below the apex, which are the most tilted from the concave side of the curvature of the spine.

次要结局

  • Walter Reed Visual Assessment Scale(Change from pretreatment and 8 weeks after treatment.)
  • Scoliosis Research Society-22(Change from pretreatment and 8 weeks after treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eylem KÜÇÜK

Principal Investigator

Hacettepe University

研究点 (2)

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