Clinical trial NCT05039255: Acute Effects of Self-correcting Movement on the Balance and Spine of Patients With Scoliosis.
Official title: Acute Effects of Self-correcting Movement on the Balance and Spine of Patients With Scoliosis. Observational Clinical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scoliosis Idiopathic
Keywords: Scoliosis
self elongation movement
balance
spine curves
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 35
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, of both sexes, affected by idiopathic scoliosis recruited at the Pediatric Orthopedics Outpatient Department of the University Hospital "Istituto di Cura Città di Pavia".

Brief summary: The purpose of this study is to evaluate the acute effects of the self-elongation movement on the balance of patients (aged 8-16 years) suffering from adolescent idiopathic scoliosis,

Detailed description: Recruitment will be carried out by the physician during the scheduled follow-up. The participant and both parents, or the legal guardian, will receive information on the purpose and methods of this study. The informed consent of both parents, or the legal guardian, and of the minor will be requested.

Balance data (oscillations, sway area) will be collected by letting participants get on a stabilometric platform and placing their feet on the landmarks; position will not change for the duration of the assessments.

At the same time, the modification of the amplitude of the scoliotic curves will be evaluated with the use of the Spine 3D (medical class system) which uses micro-pulse laser technology to make a three-dimensional reconstruction of the spine.

Three 10-seconds assessments will be made. In the first the subject will reproduce the position hold for the scheduled radiography and an acquisition will be performed with the Spine3D. The obtained image will be compared with the radiographic one to improve the accuracy of the next evaluations. During the last two acquisitions, the stabilometric platform and the 3D Spine will be used simultaneously and the data for the study will be collected. The second acquisition will be performed in a physiological position and the third in self-lengthening, a position used in most of the rehabilitation methods for scoliosis. The full evaluation will take approximately 15 minutes.

Eligibility criteria: Inclusion Criteria:

* diagnosis of idiopathic scoliosis, carried out by the Physician with the Adams test and the scoliometer;
* age between 8 and 16 years, both sexes;
* ability to perform the self-elongation movement;
* amplitude of the major scoliotic curve \<40 degrees Cobb;
* scheduled annual follow-up which requires a radiograph.

Exclusion Criteria:

* secondary scoliosis;
* obesity;
* orthopedic pathologies that modify the plantar supports;
* pathologies that modify balance (neurological and / or vestibular);
* inability to understand and sign informed consent / assent.

Primary outcomes:
measure: Balance during self-elongation movement
timeFrame: 15 minutes
Secondary outcomes:
measure: Size of the major curve
timeFrame: 15 minutes
measure: Number of patients who improve balance
timeFrame: 15 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Laboratory of Adapted Motor Activity (LAMA), University of Pavia, Pavia, Italy
name: Luca Marin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asomi College of Sciences, Marsa, Malta
name: Febbi Massimiliano, PhD
role: STUDY_CHAIR
affiliation: University of Pavia, Pavia, Italy
name: Luisella Pedrotti, Prof
role: STUDY_DIRECTOR
References:
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citation: Schreiber S, Parent EC, Khodayari Moez E, Hedden DM, Hill DL, Moreau M, Lou E, Watkins EM, Southon SC. Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial. PLoS One. 2016 Dec 29;11(12):e0168746. doi: 10.1371/journal.pone.0168746. eCollection 2016.
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citation: Nault ML, Allard P, Hinse S, Le Blanc R, Caron O, Labelle H, Sadeghi H. Relations between standing stability and body posture parameters in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1911-7. doi: 10.1097/00007632-200209010-00018.
citation: Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.