Acute Effects of Self-correcting Movement on the Balance and Spine of Patients With Scoliosis.

Acute Effects of Self-correcting Movement on the Balance and Spine of Patients With Scoliosis. Observational Clinical Study

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,

Study Overview

• Status: Not yet recruiting
• Conditions: Scoliosis Idiopathic

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.

• Study Type: Observational
• Enrollment (Anticipated): 35

Contacts and Locations

• Study Contact: Name: Luca Marin, PhD; Phone Number: +39 0382 433658; Email: luca.marin@unipv.it
• Study Contact Backup: Name: Matteo Chiodaroli, BcS; Phone Number: + 39 0382 433658; Email: matteochiodaroli84@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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".

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance during self-elongation movement	To evaluate the acute effects of the self-elongation movement on the balance of patients with idiopathic scoliosis, mainly in the area of postural oscillations (oscillation area).	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of the major curve	Evaluate the acute effects of the self-elongation movement on the amplitude of the major scoliotic curve, detected with Spine 3D.	15 minutes
Number of patients who improve balance	Estimation of the frequency of subjects who, following self-elongation, present an improvement in balance	15 minutes

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Luca Marin, PhD, Laboratory of Adapted Motor Activity (LAMA), University of Pavia, Pavia, Italy; Study Chair: Febbi Massimiliano, PhD, Asomi College of Sciences, Marsa, Malta; Study Director: Luisella Pedrotti, Prof, University of Pavia, Pavia, Italy

Publications and helpful links

General Publications

• 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.
• Schreiber S, Parent EC, Moez EK, Hedden DM, Hill D, Moreau MJ, Lou E, Watkins EM, Southon SC. The effect of Schroth exercises added to the standard of care on the quality of life and muscle endurance in adolescents with idiopathic scoliosis-an assessor and statistician blinded randomized controlled trial: "SOSORT 2015 Award Winner". Scoliosis. 2015 Sep 18;10:24. doi: 10.1186/s13013-015-0048-5. eCollection 2015.
• 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.
• Berdishevsky H, Lebel VA, Bettany-Saltikov J, Rigo M, Lebel A, Hennes A, Romano M, Bialek M, M'hango A, Betts T, de Mauroy JC, Durmala J. Physiotherapy scoliosis-specific exercises - a comprehensive review of seven major schools. Scoliosis Spinal Disord. 2016 Aug 4;11:20. doi: 10.1186/s13013-016-0076-9. eCollection 2016.
• Le Blanc R, Labelle H, Forest F, Poitras B, Rivard CH. [Possible relationship between idiopathic scoliosis and morphologic somatotypes in adolescent females]. Ann Chir. 1995;49(8):762-7. French.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 11, 2021
• Primary Completion (Anticipated): February 11, 2022
• Study Completion (Anticipated): February 11, 2022

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 7, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Scoliosis; balance; self elongation movement; spine curves
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: UPavia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD sharing will take place upon direct request and after having defined a method that fully respects the privacy of the participants

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No