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临床试验/NCT06416579
NCT06416579已完成不适用

Comparison of the Efficiency of Schroth Method and Schroth Method Based Virtual Reality Exercises in Individuals With Adolescent Idiopatic Scoliosis

Istanbul University - Cerrahpasa2 个研究点 分布在 2 个国家目标入组 48 人开始时间: 2024年6月1日最近更新:
适应症
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
48
试验地点
2
主要终点
Risser Sign Evaluation

研究概览

简要总结

Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine of unknown etiology, in the treatment of which physiotherapy-specific scoliosis-specific exercise (PSSE), corset and surgical treatment approaches are used depending on the severity of the curvature [8, 9]. The Schroth method, one of the PSSE methods, has been shown to reduce the severity of the curvature, Cobb angles and the need for surgery, especially in curvatures between 10-30 degrees, slow down the progression of the curvature, increase back muscle strength and improve respiratory functions [10-12]. In the Schroth method, mental imagery, exteroceptive, proprioceptive stimulations and mirror control, which follow motor learning principles and include internal focus, are used to increase body awareness and facilitate the individual's self-posture corrections with postural, sensorimotor and rotational breathing exercises specific to scoliosis [5, 10]. In cases that require long-term treatment, such as scoliosis, the motivation and participation of the child and adolescent population in particular decreases and negatively affects the success of treatment [1, 2]. Additionally, it has been reported in the literature that patients have difficulty in performing Schroth exercises at home and adapting the corrected posture to daily life[5]. For this reason, in order to maintain the corrected posture and make it permanent, motor learning-based approaches must be used [6]. Virtual reality rehabilitation (VR) creates an external focus on the individual, allows for a large number of repetitions, and thus encourages motor learning. It is also known that VR increases motivation, participation and exercise performance in children and adolescents[7]. When the literature was examined, no studies were found regarding VR in individuals with AIS.

The study will show that Schroth-based VR will be effective on spinal parameters, trunk rotation and spinal mobility parameters in cases with AIS. Our aim is to examine the effects of Schroth-based VR in comparison with Schroth exercises in cases with AIS.

详细描述

Schroth method, applied in the conservative treatment of adolescent idiopathic scoliosis (AIS), uses internally focused feedback to increase body awareness and maintain corrected posture. However, it has been reported in the literature that patients have difficulty in performing exercises at home and adapting the corrected posture to daily life[5]. In addition, since scoliosis rehabilitation requires long-term follow-up, patients' participation in treatment, motivation and exercise performance decrease over time [1, 2]. Virtual reality rehabilitation (VR) creates an external focus on the individual, allows for a large number of repetitions, and thus encourages motor learning [3, 4, 6]. It is also known that SGR increases motivation, participation and exercise performance in children and adolescents[7]. When the literature was examined, no studies were found regarding SGR in individuals with AIS.

The primary aim of our study is to investigate the comparative effects of Schroth-based VR and Schroth exercises on spinal parameters, trunk rotation and spinal mobility in cases with AIS. This study's secondary aim is that these exercise trainings; To comparatively examine the effects on postural parameters, trunk isometric muscle strength, endurance, proprioception, deformity perception, quality of life and satisfaction.

H1 hypothesis: There is a difference between the effects of Schroth-based SGR and Schroth exercises on spinal parameters, trunk rotation and spinal mobility in cases with AIS.

H0 hypothesis: In cases with AIS, there is no difference between the effects of Schroth-based SGR and Schroth exercises on spinal parameters, trunk rotation and spinal mobility.

Cases that meet the inclusion criteria will be randomly divided into groups as Group I - Schroth Group, Group II - SGR Group -, Group III - Control Group, and a 24-week program will be applied. Evaluations will be performed at baseline, 12 and 24 weeks. We think that our study will be an effective, innovative, technology-based approach that will contribute to the development of spinal and postural parameters in cases with AIS.

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 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Having been diagnosed with Adolescent Idiopathic Scoliosis by an orthopedic specialist
  • Being between the ages of 10 and 15
  • Risser 0-3 stage
  • The Cobb angle determined on the anteroposterior radiograph should be 10-30 degrees.
  • Major curvature being lumbar curvature
  • No pulmonary or rib cage-related disease such as rib fracture, atelectasis, or asthma
  • Ability to understand and follow instructions
  • Volunteering to participate in the study

排除标准

  • Using a brace
  • Having received any scoliosis treatment or spine surgery within the last year
  • The patient has any contraindications to exercise
  • Presence of neuromuscular, orthopedic, rheumatic diseases or vestibular problems that may affect balance, vision-related diseases or mental problems.
  • Another exercise or physical activity that may affect trunk muscle strength or balance
  • Presence of any problem that may affect walking other than scoliosis
  • Patients who cannot understand and follow instructions

研究组 & 干预措施

Group I-Schroth Exercise Group

Experimental

Participants will be given individually structured scoliosis-specific three-dimensional exercises according to the Schroth method, 2 days a week for 12 weeks, 1 day a week for the next 12 weeks, under the supervision of a physiotherapist, for a total of 36 sessions. Participants will be given a home exercise program to do on the days they do not come to the session, and will be asked whether they have done it or not when they come to each session. The exercise program will be divided into 4 phases: 0-4, 5-8, 9-12, 12-24. Progress in the exercises will be made positionally by increasing the number of repetitions and the number of rotational breathing during the exercise.

干预措施: Schroth Exercise Group (Other)

Group II-Schroth Method Based Virtual Reality Group

Experimental

Participants will undergo a Schroth method-based virtual reality exercise program under the supervision of a physiotherapist, 2 days a week for 12 weeks, and 1 day a week for the next 12 weeks, for a total of 36 sessions. Participants will be given a home exercise program to do on the days they do not come to the session, and will be asked whether they have done it or not when they come to each session. Schroth method based virtual reality exercise program will be made on Nintendo Wii. Games within Nintendo Wii will be implemented in individually configured positions in accordance with the Schroth method.The virtual reality exercise program will be divided into 4 phases: 0-4, 5-8, 9-12, 12-24. Sessions will last 40 minutes in total, including 5 minutes of warm-up, 30 minutes of balance and sports games, and 5 minutes of cool-down. Progression will be made by difficulty level and positional in all games.

干预措施: Schroth Method Based Virtual Reality Group (Other)

Group III-Control Group

Other

Participants in the control group will be placed on a waiting list for 24 weeks. Participants will be given initial, intermediate and final evaluations. Participants will not receive any exercise intervention for 24 weeks and will be able to continue their routine physical activities.

干预措施: Control Group (Other)

结局指标

主要结局

Risser Sign Evaluation

时间窗: Baseline and 24th week

Risser sign is defined as the change of the pelvic growth plate from cartilage to bone. Gradual ossification of the growth plate on the iliac apophysis from anterolateral to posteromedial is evaluated. Evaluations will be determined by the orthopedic and traumatology physician during routine follow-ups of the patient based on x-rays.

Angle of Trunk Rotation Measurement

时间窗: Baseline, 12th week and 24th week

Trunk rotation angle will be measured with a Bunnell scoliometer. There is a metal sphere inside the scoliometer that moves between 0-30˚ in the water bed. Measurements will be made by placing the scoliometer vertically on the axial axis of the spine, perpendicular to the spinosus processes of the vertebra. The evaluation will be carried out standing, in a forward bending position with hands extended forward. To adjust the distance between the feet, the physiotherapist places one foot between the patient's two feet and the patient is positioned. By moving the scoliometer from the beginning of the thoracic region to the sacrum, the largest rotation angle in the major curvature will be recorded. In our study, trunk rotation angle will be measured and recorded at baseline, at week 12, and after 24 weeks of treatment.

Spinal Parameters

时间窗: Baseline and 24th week

The most commonly used method to measure the size of the scoliosis curve is the Cobb angle. As a standard, measurement is made on a posteroanterior spine radiograph taken while standing. To determine the boundaries of scoliosis, a line is drawn parallel to the upper line of the vertebra with the greatest deviation. Similarly, for the lower border, a line is drawn parallel to the lowest vertebra. Vertical lines parallel to these two lines are drawn and the angle between the two lines is recorded. In our study, the Cobb angle will be measured and recorded in the sagittal and frental planes, based on the same vertebral endplates, on the spine x-ray taken at the beginning and after 24 weeks of treatment by the orthopedic and traumatology physician during the routine follow-up of the patient.

Spinal Mobility Evaluation

时间窗: Baseline, 12th week and 24th week

Evaluation of spinal mobility was performed with a portable, computer-aided electromechanical device (the Spinal Mouse System, Idiag, Fehraltorf, Switzerland) called "Spinal Mouse" (SM). The SM is an external, non-invasive measurement device that can evaluate spinal angles and curvatures in the frontal and sagittal planes. It has been reported that SM can be used as a reliable, fast and easy-to-use measurement method with no side effects for clinical research and patient follow-up in AIS. Measurements were made between the spinous process of the 7th cervical vertebra and the top of the anal fold (approximately the level of the sacral 3rd vertebra). Maximum right-left lateral flexion degrees in the frontal plane and maximum flexion-extension degrees in the sagittal plane will be measured and recorded.

次要结局

  • Trunk Isometric Muscle Strength(Baseline, 12th week and 24th week)
  • Posterior Trunk Symmetry Index (POTSI)(Baseline, 12th week and 24th week)
  • Trunk Muscle Endurance(Baseline, 12th week and 24th week)
  • Spinal proprioception assessment:(Baseline, 12th week and 24th week)
  • Anterior Trunk Symmetry Index (ATSI)(Baseline, 12th week and 24th week)
  • Walter Reed Visual Assessment Scale (WRVAS)(Baseline, 12th week and 24th week)
  • Global Rating of Change (GRC):(Baseline, 12th week and 24th week)
  • "Scoliosis Research Society Scale-22 (SRS-22)"(Baseline, 12th week and 24th week)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Irem Kurt

PhD (c)

Istanbul University - Cerrahpasa

研究点 (2)

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