Effectiveness of Rehabilitation With Technology-Based Systems in Adolescent Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Posterior Trunk Symmetry Index (POTSI)
研究概览
简要总结
The aim of this study was to investigate the effect of technology-based exercises on treatment success in adolescents with idiopathic scoliosis.
Within the scope of the study, twenty five patients with AIS will be randomly allocated to two groups. The control group will apply a program with conventional approaches consisting of a combination of structured three-dimensional scoliosis exercises, core stabilization and balance exercises. Patients in the intervention group will perform structured three-dimensional scoliosis exercises, core stabilization and balance exercises similarly to the control group. However, patients in the intervention group will perform core stabilization and balance exercises with virtual reality games for twenty-four weeks. Patients' Cobb angle, Pediatric Berg Balance Scale (balance), Posterior Trunk Asymmetry Index (POTSI) (cosmetic), Walter Reed Visual Assessment Scale (WRVAS)(cosmetic), System Usability Scale (system usability) and Physical Activity Participation Motivation Scale (PAPMS) (motivation) parameters will be assess at the beginning of treatment, third and six month.
详细描述
Adolescent idiopathic scoliosis (AIS) is a three-dimensional structural deformity in growing children, not associated with a cause, in which lateral deviation of the spine over 10° is accompanied by rotation. The magnitude of the Cobb angle is used to classify the severity of scoliosis. In immature AIS cases, if the Cobb angle is between 25°-40°, bracing and exercise therapy is applied. Exercise in AIS is performed to reduce clinical symptoms, improve cosmetics and prevent curve progression. Corrective exercises based on sensorimotor and kinesthetic principles include self-correction in front of a mirror, three-dimensional breathing techniques and home exercise programs.
Virtual reality applications (VRA) are three-dimensional computer simulations that give the individual the feeling of "being anywhere" and provide various information (light, sound and others) to the sensory organs. VRS is based on motor learning principles. The possibility of repetitive movements and computer feedback results in positive changes at the cortical level. In addition, the virtual environment increases the motivation of the individual and ensures active participation in the treatment.
A review of the literature reveals that there are very limited studies on technology-based applications or virtual reality in scoliosis rehabilitation. To the best of our knowledge, it has been observed that there is no long-term rehabilitation protocol applied on the basis of rehabilitative game therapy in AIS rehabilitation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with Adolescent Idiopathic Scoliosis,
- •Female participants aged between 10 and 14 years,
- •Being the Cobb angle between 25-40 degrees,
- •Being using three dimensional brace,
- •Being immature (Risser 0-2 or Sanders 1-4 phase)
- •Regular follow-ups (0-3-6 months)
排除标准
- •Presence of previous spinal surgery,
- •Progression resulting in the necessity of surgery,
- •Participation in any exercise therapy program,
- •Playing sports at a professional level,
- •Cardiac and respiratory dysfunction and/or concomitant systemic disease,
- •Health (mental, orthopedic) problems that prevent exercise
研究组 & 干预措施
Control Group:
The control group will perform the structured three-dimensional scoliosis exercise, core stabilization, and balance exercise with conventional methods at the clinic and home setting for twenty-four weeks. One clinic-based and one online supervised session per week, each lasting 45-55 minutes, together with a home exercise program performed three days per week for 24 weeks. Patients will be asked to perform their exercises as a home exercise program on the remaining days (home exercise program 3 days a week for the first 12 weeks, 4 days a week after week 12).
干预措施: Conservative Approach (Other)
Rehabilitative Game Based Exercise Group
The Rehabilitative Game-Based Exercise group will perform the structured three-dimensional scoliosis exercise with conventional methods similar to the control group. Differently, technology-based systems (BeCure Systems) will be used in the implementation of core stabilization and balance exercises. Patients will be asked to perform their exercises as a home exercise program on the remaining days (home exercise program 3 days a week for the first 12 weeks, 4 days a week after week 12).
干预措施: Rehabilitative Game Therapy (Other)
结局指标
主要结局
Posterior Trunk Symmetry Index (POTSI)
时间窗: At the beginning of the study, third month and sixth month of the study
POTSI is a method that makes it possible to evaluate the trunk asymmetry of an individual with AIS from the posterior and objectively scores the cosmetic effect. It is based on certain calculations performed on a posterior photograph of the individual. The score calculated in POTSI analysis consists of the sum of 6 indices. In order to prevent possible calculation errors and standardize the measurements, the cases will be evaluated with a mobile application named POTSIApp.
Cobb Angle
时间窗: At the beginning of the study and sixth month of the study
In the treatment of scoliosis, the Cobb angle is considered the most important outcome for the evaluation of treatment efficacy. The Cobb angle is measured from anteroposterior graphs taken during standing. Measurements will be taken by a blinded assessor via SurgiMap web application to eliminate individual errors. Measurements will be made from radiographs taken at the beginning and sixth month of treatment because of the radiation exposure.
Walter Reed Visuel Assessment Scale (WRVAS)
时间窗: At the beginning of the study, third month and sixth month of the study
WRVAS is a scale that scores the severity of curvature by focusing on the person's perception of posture. It is divided into 7 parameters including body curvature, rib prominence, lumbar prominence, head-rib-pelvis positional relationship, head-pelvis relationship, shoulder level and scapula rotation. A high score means that the perceived deformity is high.
次要结局
- Single Leg Balance Test(At the beginning of the study, third month and sixth month of the study)
- The Physical Activity Participation Motivation Scale (PAPMS)(At the beginning of the study, third month and sixth month of the study)
- The System Usability Scale (SUS)(At the beginning of the study, third month and sixth month of the study)
- Angle of Trunk Rotation(At the beginning of the study, third month and sixth month of the study)
研究者
hande tunc
Doctor of Philosophy Candidate (PhD(c))
Istanbul Medipol University Hospital