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

NCT03494829 | Unknown DMC

• 1 other identifier: OUHRH
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Airway resistance, assessed by use of plethysmography

  Change in measures from baseline and to 12 months

• Pulmonary residual volume and total lung capacity, assessed by use of plethysmography

  Change in measures from baseline and to 12 months

• Pulmonary function, assessed by use of diffusion capacity test

  Change in measures from baseline and to 12 months

• Pulmonary function, assessed by use of spirometry

  Change in measures from baseline and to 12 months

• Forced expiratory flow, assessed by use of spirometry

  Change in measures from baseline and to 12 months

Eligibility Criteria

• Age: 1 Year - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• Other spinal disease, not early onset scoliosis

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Rikshospitalet

Oslo, 0372, Norway

Location

MeSH Terms

Conditions

Scoliosis; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior

Study Officials

• Thomas Johan Kibsgård, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: April 11, 2018
• Study Start: November 1, 2016
• Primary Completion: January 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)