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临床试验/NCT04357561
NCT04357561Unknown不适用

Investigation of The Effects of Scoliosis Specific Exercises Before Adolescent Idiopathic Scoliosis Surgery

Marmara University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Functional performance

研究概览

简要总结

The aim of this study is to investigate the effects of scoliosis-specific exercises in adolescent idiopathic scoliosis patients, who had surgical indication, on functional capacity, cosmetic deformity perception, quality of life in postoperative period.

详细描述

30 adolescent idiopathic scoliosis patients, who had surgery indication and aged between 10-18 years, will be included. The participants will be randomised into two groups. 15 patients will be included in the exercise group and 15 patients in the control group. In the exercise group, a total of 12 sessions of exercise are planned, 6 weeks before the surgery and 2 days per week. In the control group, the exercise protocol will not be performed before surgery.

The outcomes will include the cosmetic deformity, quality of life, pain level, functional capacity, spine flexibility. In the exercise group, the evaluations will be made in the first interview (before exercise application), at the end of 6 weeks of exercise (when the exercise program is completed), in the early postoperative period and 12 weeks after surgery. Evaluations in the control group will be carried out at the first interview, at the 6th week, in the early postoperative period, and at the 12th week postoperatively.

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
None

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 between 10 and 18 years
  • To have surgery indication

排除标准

  • Leg discrepancy
  • Cervical region participation to curve
  • Additional disease may cause respiratory problem

结局指标

主要结局

Functional performance

时间窗: Change from baseline at week 6, postoperative 4.week, postoperative 12.week

Six-minute walking test will be used. The patients will be asked to walk at his/her own pace of walking in a 30 meter course. The distance walked over a span of 6 minutes will be recorded.

Pain perception

时间窗: Change from baseline at week 6, postoperative 4.week, postoperative 12.week

Pain level will be evaluated with visual analog scale. Patients will be asked to indicate their pain level in activity and in rest period.

Trunk rotation

时间窗: Change from baseline at week 6, postoperative 4.week, postoperative 12.week

Trunk rotation will be measured with scoliometer while the patient is in forward bending position with barefoot. The highest value in each part will be recorded.

Spine flexibility

时间窗: Change from baseline at week 6, postoperative 4.week, postoperative 12.week

Forward bending test will be applied. The patient is asked to reach the feet with his hands while sitting on a hard floor with both feet extended, with feet 15 cm apart from each other, based on a 25 cm long step, without bringing the knees flexed. measured and saved as centimeter. Side bending test will be used to measure the flexibility of spine in right and left lateral flexion. The patient is asked to bend his back to the right and left sides, without separating his back from the wall. The result sill be recorded as centimeter.

Health related quality of life

时间窗: Change from baseline at week 6, postoperative 4.week, postoperative 12.week

Scoliosis Research Society-30 will be used for quality of life evaluation. This questionnaire consists of 30 questions, scored between 1 and 5, and evaluate pain, function, self-image, mental health and treatment satisfaction. Pediatric Quality of Life Inventory is a self-report questionnaire developed for children and their families. consists of 22 questions and evaluate physical and psychosocial health. Higher scores indicate better quality of life.

Cosmetic deformity perception

时间窗: Change from baseline at week 6, postoperative 4.week, postoperative 12.week

Walter Reed Visual Assessment Scale-Walter Reed Visual Assessment Scale will be used to evaluate individuals' self-perception of cosmetic deformities and the effectiveness of treatment in improving body cosmetic deformity. It focuses on the person's perception of posture and the severity of the curve. This questionnaire is divided into 7 parameters including body curvature, rib prominence, waist prominence, head-rib-pelvis positional relation, head-pelvis relation, shoulder level and scapula rotation. Each parameter is scored from 1 to 5.

次要结局

未报告次要终点

研究者

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

Tugce Ozen

Research Assistant

Marmara University

研究点 (2)

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