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临床试验/NCT04568759
NCT04568759进行中(未招募)不适用

Randomized Controlled Trial to Evaluate the Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent

St. Justine's Hospital4 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2021年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
47
试验地点
4
主要终点
Change in Cobb angle of at least 5 degrees

研究概览

简要总结

The aim of this project is to verify the effect of the global postural reeducation (GPR) intervention used in physiotherapy on scoliosis progression (scoliosis angle), back pain, quality of life, respiratory function, trunk posture and trunk muscle functioning and walking endurance. To do so, we will recruit 144 participants at three scoliosis specialized Centers. Participants will be randomly allocated to the standard of care (SC) group (observation or brace plus home video of exercises for 12 months) or to the GPR group (SC plus individual sessions once a week for 6 months and individual sessions alternating with telerehabilitation sessions once per two weeks between 6 and 12 months). At initial, 6, 12- and 24-months evaluation, participants will have x-ray, complete self-report questionnaires to document back pain and quality of life. Thereafter, measurement of trunk posture, electromyography activity of the back muscles, excursion of the diaphragm muscle using echography and respiratory function as well as distance covered using the 6-minute walk test for walking endurance will be done. We believe that GPR intervention may prevent scoliosis progression and improve physical health and quality of life in adolescence.

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 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • aged between 10 and 16 years old,
  • Cobb angle between 15º and 45º,
  • Risser sign ≤3 (skeletal growth incomplete),
  • with a risk of progression index > 1.3,
  • having recent x-rays (4-6 weeks),
  • ability to travel weekly to attend GPR intervention

排除标准

  • patients with diagnosis other than AIS,
  • patients who are planned for surgery,
  • have had surgery,
  • worn a brace for at least three months prior to GPR intervention

结局指标

主要结局

Change in Cobb angle of at least 5 degrees

时间窗: 6, 12 and 24 months

Angle measured on radiograph for scoliosis progression

次要结局

  • Back pain on the Numerical Pain Rating Scale(6, 12 and 24 months)
  • Italian Spine Youth Quality of Life questionnaire(6, 12 and 24 months)
  • Trunk imbalance(6 and 12 months)
  • Diaphragm excursion(6 and 12 months)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carole Fortin

Associate professor

St. Justine's Hospital

研究点 (4)

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