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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03494829
• Other study ID #: OUHRH
• Status: Enrolling by invitation
• Start date: November 2016
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 20 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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.