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ScoliosisNCT02978820

The Comparison of Core Stabilization Exercise With Scientific Exercise Approach to Scoliosis in Idiopathic Scoliosis

A study testing SEAS exercise and CS exercise in people with Scoliosis and Adolescent Idiopathic Scoliosis, run by Hacettepe University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Scoliosis specific exercises have been shown to improve curve progression but there have been few studies that compare the different exercise approaches in adolescent idiopathic scoliosis (AIS). Read more about this study

Who is it for?
Ages 12 to 16 years, women only
Conditions the study is for
Scoliosis, Adolescent Idiopathic Scoliosis
What is being tested?
SEAS exercise and CS exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Nov 2015to Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 16 years
  • Women only
  • No healthy volunteers
  • Child

Who may be able to join

  • The patients included in the current study were consecutive adolescents with idiopathic scoliosis seen in our department who were referred to receive both brace and exercise treatment conservatively. Additional inclusion criteria included the following: female gender; at least age 12 years; primary curve magnitude between 20 and 45 degrees of Cobb angle; double curve (right thoracic-left lumbar) or single thoracolumbar curve having an apex in the main thoracic region; Risser 2-3 and no previous treatment.

Who cannot join

  • Exclusion criteria for both groups were as follows: evidence of congenital curve; neuromuscular, rheumatologic, renal, cardiovascular, pulmonary or vestibular diseases or surgical correction history.

About this study

Official title: Core Stabilization Exercise Versus Scientific Exercises Approach to Scoliosis in the Treatment of Adolescent Idiopathic Scoliosis: A Randomized Single Blind Trial

Scoliosis specific exercises have been shown to improve curve progression but there have been few studies that compare the different exercise approaches in adolescent idiopathic scoliosis (AIS). The objective of this study was to compare the effects of Core stabilization (CS) exercises with Scientific Exercises Approach to Scoliosis (SEAS exercises) in addition to brace wearing in patients with AIS. It is important to compare different exercise methods on different aspects of scoliotic deformity, such as curve progression, angle of trunk rotation, body symmetry, cosmetic trunk deformity, satisfaction with treatment and quality of life.

Read the detailed description

The aim of this study was to investigate whether adolescent with idiopathic scoliosis receiving scoliosis specific exercise approach, such as SEAS exercises, in accordance with the bracing approach for moderate curves would have greater improvement in curve progression, trunk deformity, body symmetry and quality of life than adolescent receiving exercise therapy based on the general core stabilization approach with similar intensity. Thirty female patients with AIS aged 12 to16 years, who have moderate curves (20 to 45 degree) randomly divided into two groups. One group received CS exercise, while other received SEAS exercise for forty-min once weekly for four months. Both groups underwent full-time bracing (23 hours per day) intervention. Outcome was based on Cobb angle, angle of trunk rotation, body symmetry (Posterior Trunk Symmetry Index), cosmetic trunk deformity (Walter Reed Visual Assessment Scale) and quality of life (Scoliosis Research Society - 22 Questionnaire) measured at baseline and after intervention period. Results were analyzed using the paired sample t-test to compare repeated measurements and independent sample t-test to compare the groups.

Being tested
SEAS exercise, CS exercise
Keywords
scientific exercise approach to scoliosis, core stabilization training, bracing, adolescent idiopathic scoliosis
Medical subject headings
Scoliosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SEAS exerciseOther

    Patient were referred by medical doctor with a prescription of brace and exercise training for their moderate scoliotic curves. Patients were randomly divided into two groups. The SEAS group received SEAS exercises one times in a week for four months. In addition patients in SEAS groups were wearing spinal brace for their scoliosis in this period

  • CS exerciseOther

    Patient were referred by medical doctor with a prescription of brace and exercise training for their moderate scoliotic curves. Patients were randomly divided into two groups. The CS group received core stabilization exercise training one times in a week for four months. In addition patients in SEAS groups were wearing spinal brace for their scoliosis in this period

Study groups in NCT02978820
Study groupRoleWhat they receive
SEAS exercise groupExperimentalThis group received SEAS exercises in addition to brace wearing for four months
Receives: Other: SEAS exercise
CS exercise groupExperimentalThis group received core stabilization exercise training (CS) in addition to brace wearing for four months
Receives: Other: CS exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Cobb angle

    Cobb angle is considered a gold standard to determine the magnitude of spinal curve on frontal plan radiograph

    Measured: Change from baseline Cobb angle at 4 months

Secondary outcomes (4)

  1. Chance in Posterior trunk symmetry index

    Posterior trunk symmetry index includes the sensitive assessment of the frontal plane asymmetry of trunk deformity as a two-dimensional surface topographic method in scoliosis. The index based on assessing trunk asymmetry with regard to C7 plumb line, shoulder and hip asymmetry based on back surface photograph of patient.

    Measured: Change from baseline trunk symmetry at 4 months

  2. Change in Walter reed visual assessment scale

    Walter reed visual assessment scale assesses patient's cosmetic trunk deformity with set of figures representing seven visible aspects of spinal deformity: Item 1, spinal deformity; item 2, rib prominence; item 3, lumbar prominence; item 4, thoracic deformity; item 5, trunk imbalance; item 6, shoulder asymmetry; and item 7, scapular asymmetry

    Measured: Change from baseline cosmetic trunk deformity at 4 months

  3. Change in Scoliosis Research Society 22 Questionnaire

    Scoliosis Research Society 22 Questionnaire is widely used to evaluate the efficacy of several treatment regimens for idiopathic scoliosis from the patient's perception of his or her condition. The questionnaire consists of 22 items exploring 5 domains related to psychophysical wellbeing: function/activity level, pain, mental health, self-image and treatment satisfaction.

    Measured: Change from baseline quality of life at 4 months

  4. Change in Angle of trunk rotation

    Angle of Trunk rotation is assessed with scoliometer in forward bending test

    Measured: Change from baseline angle of trunk rotation at 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionSep 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02978820
Sponsor's protocol ID
GO 16/82
Status last verified
Nov 2016
First submitted
20 Nov 2016
Last updated
1 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Negrini S, Aulisa AG, Aulisa L, Circo AB, de Mauroy JC, Durmala J, Grivas TB, Knott P, Kotwicki T, Maruyama T, Minozzi S, O'Brien JP, Papadopoulos D, Rigo M, Rivard CH, Romano M, Wynne JH, Villagrasa M, Weiss HR, Zaina F. 2011 SOSORT guidelines: Orthopaedic and Rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis. 2012 Jan 20;7(1):3. doi: 10.1186/1748-7161-7-3.

    PubMed 22264320

  • Negrini S, Grivas TB, Kotwicki T, Maruyama T, Rigo M, Weiss HR; Members of the Scientific society On Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT). Why do we treat adolescent idiopathic scoliosis? What we want to obtain and to avoid for our patients. SOSORT 2005 Consensus paper. Scoliosis. 2006 Apr 10;1:4. doi: 10.1186/1748-7161-1-4.

    PubMed 16759352

  • Weinstein SL. Adolescent idiopathic scoliosis: prevalence and natural history. Instr Course Lect. 1989;38:115-28.

    PubMed 2649564

  • Smania N, Picelli A, Romano M, Negrini S. Neurophysiological basis of rehabilitation of adolescent idiopathic scoliosis. Disabil Rehabil. 2008;30(10):763-71. doi: 10.1080/17483100801921311.

    PubMed 18432434

  • Fusco C, Zaina F, Atanasio S, Romano M, Negrini A, Negrini S. Physical exercises in the treatment of adolescent idiopathic scoliosis: an updated systematic review. Physiother Theory Pract. 2011 Jan;27(1):80-114. doi: 10.3109/09593985.2010.533342.

    PubMed 21198407

  • Romano M, Negrini A, Parzini S, Tavernaro M, Zaina F, Donzelli S, Negrini S. SEAS (Scientific Exercises Approach to Scoliosis): a modern and effective evidence based approach to physiotherapic specific scoliosis exercises. Scoliosis. 2015 Feb 5;10:3. doi: 10.1186/s13013-014-0027-2. eCollection 2015.

    PubMed 25729406

  • Gur G, Ayhan C, Yakut Y. The effectiveness of core stabilization exercise in adolescent idiopathic scoliosis: A randomized controlled trial. Prosthet Orthot Int. 2017 Jun;41(3):303-310. doi: 10.1177/0309364616664151. Epub 2016 Sep 13.

    PubMed 27625122

Questions about this trial

What is this clinical trial studying?

A study testing SEAS exercise and CS exercise in people with Scoliosis and Adolescent Idiopathic Scoliosis, run by Hacettepe University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cobb angle (time frame: Change from baseline Cobb angle at 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02978820, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.

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