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

NCT ID: NCT05039255

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-11
• Study Completion Date: 2022-02-11

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.

Conditions

Scoliosis Idiopathic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Marin, PhD

Role: PRINCIPAL_INVESTIGATOR

Laboratory of Adapted Motor Activity (LAMA), University of Pavia, Pavia, Italy

Febbi Massimiliano, PhD

Role: STUDY_CHAIR

Asomi College of Sciences, Marsa, Malta

Luisella Pedrotti, Prof

Role: STUDY_DIRECTOR

University of Pavia, Pavia, Italy

Central Contacts

Luca Marin, PhD

Role: CONTACT

luca.marin@unipv.it

+39 0382 433658

Matteo Chiodaroli, BcS

Role: CONTACT

matteochiodaroli84@gmail.com

+ 39 0382 433658

References

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.

Reference Type: BACKGROUND

PMID: 26413145 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28033399 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27525315 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8561432 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12221357 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29435499 (View on PubMed)

Other Identifiers

UPavia

Identifier Type: -

Identifier Source: org_study_id