NCT05039255

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,

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 11, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2022

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

September 7, 2021

Last Update Submit

September 27, 2021

Conditions

Keywords

Scoliosisself elongation movementbalancespine curves

Outcome Measures

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).

    15 minutes

Secondary Outcomes (2)

  • Size of the major curve

    15 minutes

  • Number of patients who improve balance

    15 minutes

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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".

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 26413145BACKGROUND
  • 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.

    PMID: 28033399BACKGROUND
  • 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.

    PMID: 27525315BACKGROUND
  • 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.

    PMID: 8561432BACKGROUND
  • 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.

    PMID: 12221357BACKGROUND
  • 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.

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Luca Marin, PhD

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

    PRINCIPAL INVESTIGATOR
  • Febbi Massimiliano, PhD

    Asomi College of Sciences, Marsa, Malta

    STUDY CHAIR
  • Luisella Pedrotti, Prof

    University of Pavia, Pavia, Italy

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2021

First Posted

September 9, 2021

Study Start

October 11, 2021

Primary Completion

February 11, 2022

Study Completion

February 11, 2022

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

IPD sharing will take place upon direct request and after having defined a method that fully respects the privacy of the participants