Scoliosis; Idiopathic, InfantileNCT03494829
Physical Activity, Motor Competence, Pulmonary Function, and Quality of Life in Children With Severe Spinal Disease
An observational study of Scoliosis; Idiopathic, Infantile and Scoliosis; Juvenile, run by Oslo University Hospital at 1 site in Norway.
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 Read more about this study
- Who is it for?
- Ages 1 year to 20 years
- Conditions the study is for
- Scoliosis; Idiopathic, Infantile, Scoliosis; Juvenile, Scoliosis Neuromuscular
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2016to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children treated at the Norwegian National Unit for Surgical Treatment of Non-malignant Pathologies in Pediatric Spine, Oslo University Hospital
Who may be able to join
- 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
Who cannot join
- Other spinal disease, not early onset scoliosis
Trial locations and contacts
1 site in 1 country.
About this study
Observation study about physical activity, motor competence, pulmonary function, and health related quality of life in children, surgically treated for early onset scoliosis
Read the 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
- Keywords
- early onset scoliosis, motor competence, physical activity, pulmonary function, health related quality of life
- Medical subject headings
- Scoliosis, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change in activity counts from baseline to activity counts at 6 months and 12 months.
Secondary outcomes (10)
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
Measured: 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.
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.
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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: Change in subjective answers of everyday activity from baseline, to 6 mounts and to 12 mounts.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study startNov 2016
- Primary completionJan 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; Idiopathic, InfantileStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Johan Kibsgård, Oslo University Hospital
- Investigators
- Thomas Johan Kibsgård, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494829
- Sponsor's protocol ID
- OUHRH
- Status last verified
- Sep 2021
- First submitted
- 15 Mar 2017
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Motor Competence, Pulmonary Function, and Quality of Life in Children With Severe Spinal Disease
- ClinicalTrials.gov ID
- NCT03494829
- Acronym / sponsor ID
- OUHRH
- Conditions
- Scoliosis; Idiopathic, Infantile, Scoliosis; Juvenile, Scoliosis Neuromuscular, Scoliosis in Neurofibromatosis, Scoliosis; Congenital, Postural, Scoliosis in Skeletal Dysplasia
- Keywords
- early onset scoliosis, motor competence, physical activity, pulmonary function, health related quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children treated at the Norwegian National Unit for Surgical Treatment of Non-malignant Pathologies in Pediatric Spine, Oslo University Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Other spinal disease, not early onset scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical Activity, assessed by use of accelerometer
Time frame: Change in activity counts from baseline to activity counts at 6 months and 12 months.
Physical Activity will be measured objective by use of an accelerometer (used over 7 days), recorded as Activity Counts/ minutes
10 secondary outcomes
Airway resistance, assessed by use of plethysmography
Time frame: Change in measures from baseline and to 12 months
Pulmonary residual volume and total lung capacity, assessed by use of plethysmography
Time frame: Change in measures from baseline and to 12 months
Pulmonary function, assessed by use of diffusion capacity test
Time frame: Change in measures from baseline and to 12 months
Pulmonary function, assessed by use of spirometry
Time frame: Change in measures from baseline and to 12 months
Forced expiratory flow, assessed by use of spirometry
Time frame: Change in measures from baseline and to 12 months
Motor competence, assessed by use of Movement Assessment Battery of Children- 2. edition
Time frame: Baseline and after 12 months
Health related quality of life in children
Time frame: 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
Time frame: Change in subjective answers of health related quality of life from baseline, to 6 mounts and to 12 mounts.
Shoulder function
Time frame: Baseline and after 12 months
Physical Activity, assessed by use of questionnaire
Time frame: Change in subjective answers of everyday activity from baseline, to 6 mounts and to 12 mounts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Johan Kibsgård, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis; Idiopathic, Infantile and Scoliosis; Juvenile, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity, assessed by use of accelerometer (time frame: Change in activity counts from baseline to activity counts at 6 months and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.