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

NCT ID: NCT03494829

Last Updated: 2021-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2022-12-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Thomas Johan Kibsgård

Senior Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Johan Kibsgård, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Countries

Norway

Other Identifiers

OUHRH

Identifier Type: -

Identifier Source: org_study_id