Clinical trial NCT04568759: Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent
Official title: Randomized Controlled Trial to Evaluate the Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: adolescent idiopathic scoliosis
Global postural re-education
back pain
quality of life
trunk imbalance
inter muscular coherence
respiratory function
functional performance
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Laval University
name: Shriners Hospitals for Children
name: Université de Montréal
name: CHU de Québec
First posted: 2020-09-29
Enrollment: 47
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this project is to verify the effect of the global postural reeducation (GPR) intervention used in physiotherapy on scoliosis progression (scoliosis angle), back pain, quality of life, respiratory function, trunk posture and trunk muscle functioning and walking endurance. To do so, we will recruit 144 participants at three scoliosis specialized Centers. Participants will be randomly allocated to the standard of care (SC) group (observation or brace plus home video of exercises for 12 months) or to the GPR group (SC plus individual sessions once a week for 6 months and individual sessions alternating with telerehabilitation sessions once per two weeks between 6 and 12 months). At initial, 6, 12- and 24-months evaluation, participants will have x-ray, complete self-report questionnaires to document back pain and quality of life. Thereafter, measurement of trunk posture, electromyography activity of the back muscles, excursion of the diaphragm muscle using echography and respiratory function as well as distance covered using the 6-minute walk test for walking endurance will be done. We believe that GPR intervention may prevent scoliosis progression and improve physical health and quality of life in adolescence.


Eligibility criteria: Inclusion Criteria:

* aged between 10 and 16 years old,
* Cobb angle between 15º and 45º,
* Risser sign ≤3 (skeletal growth incomplete),
* with a risk of progression index \> 1.3,
* having recent x-rays (4-6 weeks),
* ability to travel weekly to attend GPR intervention

Exclusion Criteria:

* patients with diagnosis other than AIS,
* patients who are planned for surgery,
* have had surgery,
* worn a brace for at least three months prior to GPR intervention

Primary outcomes:
measure: Change in Cobb angle of at least 5 degrees
timeFrame: 6, 12 and 24 months
Secondary outcomes:
measure: Back pain on the Numerical Pain Rating Scale
timeFrame: 6, 12 and 24 months
measure: Italian Spine Youth Quality of Life questionnaire
timeFrame: 6, 12 and 24 months
measure: Trunk imbalance
timeFrame: 6 and 12 months
measure: Diaphragm excursion
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Québec
country: Canada
facility: Centre interdisciplinaire de recherche en réadaptation et intégration sociale/Université Laval
Study officials:
affiliation: CHU Sainte-Justine/Université de Montréal
name: Carole Fortin, PhD
role: PRINCIPAL_INVESTIGATOR
References: