Physical Activity, Motor Competence, Pulmonary Function, and Quality of Life in Children With Severe Spinal Disease

Study Overview
=================
Brief Summary
-----------------
Observation study about physical activity, motor competence, pulmonary function, and health related quality of life in children, surgically treated for early onset scoliosis

Detailed Description
-----------------
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.

Official Title
-----------------
Physical Activity, Motor Competence, Pulmonary Function, and Quality of Life in Children With Severe Spinal Disease

Conditions
-----------------
Scoliosis, Scoliosis; Congenital, Postural, Scoliosis; Idiopathic, Infantile, Scoliosis; Juvenile, Scoliosis Neuromuscular, Scoliosis in Neurofibromatosis, Scoliosis in Skeletal Dysplasia, Scoliosis Associated With Other Conditions, Scoliosis; Congenital, Due to Bony Malformation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Other spinal disease, not early onset scoliosis

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity, assessed by use of accelerometer | Physical Activity will be measured objective by use of an accelerometer (used over 7 days), recorded as Activity Counts/ minutes | Change in activity counts from baseline to activity counts at 6 months and 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway resistance, assessed by use of plethysmography | Children >8 years will also be assessed by use of plethysmography. Airway resistance will be measured, recorded as the ratio of driving pressure divided by flow through the airways | Change in measures from baseline and to 12 months | 
| Pulmonary residual volume and total lung capacity, assessed by use of plethysmography | Children >8 years will also be assessed by use of plethysmography. Residual volume (liters) and total lung capacity (liters) will be measured. | Change in measures from baseline and to 12 months | 
| Pulmonary function, assessed by use of diffusion capacity test | Children >8 years will be assessed by use of diffusion capacity test. Diffusing capacity or transfer factor of the lung for carbon monoxide (CO) (DLCO) will be measured. | Change in measures from baseline and to 12 months | 
| Pulmonary function, assessed by use of spirometry | All participants will go through spirometry. Vital capacity (VC), Forced vital capacity (FVC), Forced expiratory volume (FEV) at timed intervals of 0.5, 1.0 (FEV1), 2.0, and 3.0 seconds and maximal voluntary ventilation (MVV) will be measured (liters) | Change in measures from baseline and to 12 months | 
| Forced expiratory flow, assessed by use of spirometry | All participants will go through spirometry. Forced expiratory flow 25-75% (FEF 25-75) will be measured (liters/second) | Change in measures from baseline and to 12 months | 
| Motor competence, assessed by use of Movement Assessment Battery of Children- 2. edition | Motor competence will be assessed by use of Movement Assessment Battery of Children- 2. edition | Baseline and after 12 months | 
| Health related quality of life in children | Health related quality of life will be assessed by use of the Early Onset Scoliosis 24-item Questionnaire (EOSQ-24). Total score, ranged 0 (worst) to 100 (best), including 11 subdomain scores, ranged 0 (worst) to 100 (best) will be calculated. | 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 | Among participants > 16 years, health related quality of life will be assessed by use of the Scoliosis Research Society 22- item (SRS-22) questionnaire. Total score and 5 subdomain scores, all ranged 5 (best) to 1 (worst), will be calculated. | Change in subjective answers of health related quality of life from baseline, to 6 mounts and to 12 mounts. | 
| Shoulder function | A physiotherapist will assess the active shoulder range of motion, categorized as normal, active range of motion >50% of perceived motion, or active range of motion <50% of perceived motion. shoulder flexion, extension, abduction, and rotation will be measured. | Baseline and after 12 months | 
| Physical Activity, assessed by use of questionnaire | Physical Activity will be subjective measured by use of a questionnaire regarding participants' everyday activity. Participants range their activity in several sports activities from never (1) to several days a week (4).The questionnaire is previous used in a national survey study regarding physical activity among children and adolescents in Norway. | Change in subjective answers of everyday activity from baseline, to 6 mounts and to 12 mounts. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early onset scoliosis, motor competence, physical activity, pulmonary function, health related quality of life