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

Scoliosis Idiopathic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05039255
• Other study ID #: UPavia
• Status: Not yet recruiting
• Start date: October 11, 2021
• Est. completion date: February 11, 2022

Study information

• Verified date: September 2021
• Source: University of Pavia
• Contact: Luca Marin, PhD
• Phone: +39 0382 433658
• Email: luca.marin[@]unipv.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: February 11, 2022
• Est. primary completion date: February 11, 2022
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

References & Publications (6)

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. Review. — View Citation

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. — View 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. — View 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: ort — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of patients who improve balance	Estimation of the frequency of subjects who, following self-elongation, present an improvement in balance	15 minutes