Physical Activity, Motor Competence, Pulmonary Function, and Quality of Life in Children With Severe Spinal Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Physical Activity, assessed by use of accelerometer
研究概览
简要总结
Observation study about physical activity, motor competence, pulmonary function, and health related quality of life in children, surgically treated for early onset scoliosis
详细描述
Early Onset Scoliosis (EOS) defines patients who develop deformities of the spine and/or thorax in the embryologic development or in the early childhood. The exact prevalence of EOS in Norway is unknown, but it is assumed to be approximately 200-300 new EOS patients every year. EOS is a severe condition, whereby some of the most common and also most severe consequences of the deformity are severe pulmonary problems. The patients may require extensive orthopedic treatment from early childhood and until maturity to avoid serious consequences with severe pulmonary problems and shortening of life.
EOS' secondary problems, including severe consequences on the pulmonary function might contribute to enhanced inactivity. Inactivity contributes to further negative impact on development of the musculoskeletal system, motor competence and pulmonary function. Considering the severity of EOS and children's reduced life expectancy, it is extremely important that EOS children achieve the favorable impact of physical activity during their growth. Insufficient level of activity might worsen the prognosis, thus counteracting the treatment's ambitions. The investigator's aim is to extend the knowledge about level of activity, motor competence, pulmonary function, and health related quality of life in Norwegian children, surgically treated for EOS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Early onset scoliosis diagnosis
- •Understand and speak Norwegian
- •For physical activity test: Walking ability
- •For motor competence test and/or pulmonary function test: Ability to understand the test and cooperate
排除标准
- •Other spinal disease, not early onset scoliosis
结局指标
主要结局
Physical Activity, assessed by use of accelerometer
时间窗: Change in activity counts from baseline to activity counts at 6 months and 12 months.
Physical Activity will be measured objective by use of an accelerometer (used over 7 days), recorded as Activity Counts/ minutes
次要结局
- Forced expiratory flow, assessed by use of spirometry(Change in measures from baseline and to 12 months)
- Motor competence, assessed by use of Movement Assessment Battery of Children- 2. edition(Baseline and after 12 months)
- Pulmonary function, assessed by use of spirometry(Change in measures from baseline and to 12 months)
- Health related quality of life in children(Change in parents answers of health related quality of life of their child from baseline, to 6 months and to 12 months.)
- Health related quality of life in adolescents(Change in subjective answers of health related quality of life from baseline, to 6 mounts and to 12 mounts.)
- Airway resistance, assessed by use of plethysmography(Change in measures from baseline and to 12 months)
- Pulmonary residual volume and total lung capacity, assessed by use of plethysmography(Change in measures from baseline and to 12 months)
- Shoulder function(Baseline and after 12 months)
- Pulmonary function, assessed by use of diffusion capacity test(Change in measures from baseline and to 12 months)
- Physical Activity, assessed by use of questionnaire(Change in subjective answers of everyday activity from baseline, to 6 mounts and to 12 mounts.)
研究者
Thomas Johan Kibsgård
Senior Consultant
Oslo University Hospital