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Status unknownNCT05039255Updated Sep 28, 2021

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

An observational study in Scoliosis Idiopathic, sponsored by University of Pavia. Status unknown. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2021-09-28.

Sponsored by University of Pavia · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Ages
8 Years to 16 Years
Sex
All
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Study 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,

Read the 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.

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Conditions studied

  • Scoliosis Idiopathic

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Keywords

  • Scoliosis
  • self elongation movement
  • balance
  • spine curves
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In context

Scoliosis

594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.

This study's planned enrollment of 35 is below the median of 89 across 233 observational studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

University of Pavia is the lead sponsor of 141 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 16 Years
Sexes eligible
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".

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 15 minutes

Secondary outcomes

  1. 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.

    Time frame: 15 minutes

  2. Number of patients who improve balance

    Estimation of the frequency of subjects who, following self-elongation, present an improvement in balance

    Time frame: 15 minutes

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 26413145 ↗
  • 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. PubMed 28033399 ↗
  • 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. PubMed 27525315 ↗
  • 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. PubMed 8561432 ↗
  • 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. PubMed 12221357 ↗
  • 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. PubMed 29435499 ↗

Individual participant data

Plan to share: No — IPD sharing will take place upon direct request and after having defined a method that fully respects the privacy of the participants

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05039255
Lead sponsor
University of Pavia
Responsible party
Sponsor
First posted
Sep 9, 2021
Start date
Oct 11, 2021 (estimated)
Primary completion
Feb 11, 2022 (estimated)
Completion
Feb 11, 2022 (estimated)
Last update
Sep 28, 2021

Study contacts

Luca Marin, PhD
Contact
luca.marin@unipv.it
+39 0382 433658
Matteo Chiodaroli, BcS
Contact
matteochiodaroli84@gmail.com
+ 39 0382 433658
Luca Marin, PhD
principal investigator · Laboratory of Adapted Motor Activity (LAMA), University of Pavia, Pavia, Italy
Febbi Massimiliano, PhD
study chair · Asomi College of Sciences, Marsa, Malta
Luisella Pedrotti, Prof
study director · University of Pavia, Pavia, Italy

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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