Clinical trial NCT03494829: Physical Activity, Motor Competence, Pulmonary Function, and Quality of Life in Children With Severe Spinal Disease
Official title: Physical Activity, Motor Competence, Pulmonary Function, and Quality of Life in Children With Severe Spinal Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scoliosis; Idiopathic, Infantile
Scoliosis; Juvenile
Scoliosis Neuromuscular
Scoliosis in Neurofibromatosis
Scoliosis; Congenital, Postural
Scoliosis in Skeletal Dysplasia
Scoliosis Associated With Other Conditions
Scoliosis; Congenital, Due to Bony Malformation
Scoliosis
Keywords: early onset scoliosis
motor competence
physical activity
pulmonary function
health related quality of life
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children treated at the Norwegian National Unit for Surgical Treatment of Non-malignant Pathologies in Pediatric Spine, Oslo University Hospital

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.

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

Primary outcomes:
measure: Physical Activity, assessed by use of accelerometer
timeFrame: Change in activity counts from baseline to activity counts at 6 months and 12 months.
Secondary outcomes:
measure: Airway resistance, assessed by use of plethysmography
timeFrame: Change in measures from baseline and to 12 months
measure: Pulmonary residual volume and total lung capacity, assessed by use of plethysmography
timeFrame: Change in measures from baseline and to 12 months
measure: Pulmonary function, assessed by use of diffusion capacity test
timeFrame: Change in measures from baseline and to 12 months
measure: Pulmonary function, assessed by use of spirometry
timeFrame: Change in measures from baseline and to 12 months
measure: Forced expiratory flow, assessed by use of spirometry
timeFrame: Change in measures from baseline and to 12 months
measure: Motor competence, assessed by use of Movement Assessment Battery of Children- 2. edition
timeFrame: Baseline and after 12 months
measure: Health related quality of life in children
timeFrame: Change in parents answers of health related quality of life of their child from baseline, to 6 months and to 12 months.
measure: Health related quality of life in adolescents
timeFrame: Change in subjective answers of health related quality of life from baseline, to 6 mounts and to 12 mounts.
measure: Shoulder function
timeFrame: Baseline and after 12 months
measure: Physical Activity, assessed by use of questionnaire
timeFrame: Change in subjective answers of everyday activity from baseline, to 6 mounts and to 12 mounts.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
Study officials:
affiliation: Oslo University Hospital
name: Thomas Johan Kibsgård, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: