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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Scoliosis; Scoliosis; Juvenile; Scoliosis; Idiopathic, Infantile; Scoliosis Neuromuscular; Scoliosis in Neurofibromatosis; Scoliosis; Congenital, Postural; Scoliosis in Skeletal Dysplasia; Scoliosis Associated With Other Conditions; Scoliosis; Congenital, Due to Bony Malformation

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0372
    • Oslo University Hospital, Rikshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

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.

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Thomas Johan Kibsgård, MD PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: April 6, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; pulmonary function; health related quality of life; early onset scoliosis; motor competence
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Genetic Diseases, Inborn; Musculoskeletal Diseases; Neurodegenerative Diseases; Neoplasms, Nerve Tissue; Bone Diseases; Heredodegenerative Disorders, Nervous System; Neoplastic Syndromes, Hereditary; Spinal Curvatures; Bone Diseases, Developmental; Nerve Sheath Neoplasms; Neurocutaneous Syndromes; Neurofibroma; Scoliosis; Spinal Diseases; Neurofibromatoses; Osteochondrodysplasias
• Other Study ID Numbers: OUHRH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO