Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial to Evaluate the Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent

Conditions
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Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Other: Global postural re-education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care group<br>Observation or brace plus conventional physiotherapy exercises on video | Other: Global postural re-education<br>* GPR consists of active treatment posture and sensorimotor control exercises to regain back muscle symmetry and correct posture in daily activities<br>|
| Experimental: GPR group<br>GPR interventions added to standard care (observation or brace) | Other: Global postural re-education<br>* GPR consists of active treatment posture and sensorimotor control exercises to regain back muscle symmetry and correct posture in daily activities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cobb angle of at least 5 degrees | Angle measured on radiograph for scoliosis progression | 6, 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back pain on the Numerical Pain Rating Scale | Intensity of back pain on the Numerical Pain Rating Scale (0-10, where 0 indicates no pain et 10 the worst imaginable pain) | 6, 12 and 24 months | 
| Italian Spine Youth Quality of Life questionnaire | Quality of life: score is between 0 and 100, where 100 represents a higher quality of life | 6, 12 and 24 months | 
| Trunk imbalance | The right/left horizontal deviation between the plumb line placed at C7 and S1 calculated in mm | 6 and 12 months | 
| Diaphragm excursion | Diaphragm excursion using ultrasound imaging in mm | 6 and 12 months | 
| Forced vital capacity | Measured of respiratory function using a conventional spirometer | 6 and 12 months | 
| Inter muscular coherence | Measure of the association between right and left paraspinal muscle activity at each frequency on a scale from 0 to 1, where 0 indicates independent processes and 1 indicates correlated processes. | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Global postural re-education, adolescent idiopathic scoliosis, back pain, quality of life, trunk imbalance, inter muscular coherence, respiratory function, functional performance