NCT02552615

Brief Summary

The aim of this study was to compare the effects of spinal stabilization and body awareness in addition to brace wearing versus classical exercises on subjective verticality perception, trunk symmetry and quality of life in AIS. Study included 30 AIS patients between the ages of 14.40±201 years (stabilization group), 14.2±2 years (Body awareness) and 13.60±1.65 (classical). Cobb angles, rotation, subjective visual (SVV), postural (SPV) and haptic (SHV) and deformity perception, quality of life were assessed at baseline and after 10th week of treatment. Cobb angle decreased in stabilization and awareness groups. Rotation decreased in three groups. SVV improved in all groups. SPV and SHV, body asymmetry and cosmetic deformity improved in stabilization and awareness groups. Only function improved with stabilization treatment. Stabilization and body awareness exercises created positive changes in AIS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

1.2 years

First QC Date

September 15, 2015

Last Update Submit

September 15, 2015

Conditions

Keywords

scoliosis, verticality perception, body symmetry

Outcome Measures

Primary Outcomes (1)

  • cobb angle

    Cobb's angles were measured on standard standing anterior-posterior spine radiograph and recorded as degrees. Cobb angle is considered the gold standard to evaluate the curve magnitude

    10 weeks

Secondary Outcomes (5)

  • Posterior Trunk Asymmetry Index (POTSI)

    10 weeks

  • axial trunk rotation

    10 weeks

  • Walter Reed Visual Assessment Scale (WRVAS)

    10 weeks

  • SRS-22 Questionnaire

    10 weeks

  • vertical perception

    10 weeks

Study Arms (3)

body awareness therapy (BAT)

EXPERIMENTAL

Each session started with short warm-up, continued with specific exercises. Following each session, verbal reflexions was taken for 10 minutes. Exercises fulfilled in lying, sitting, standing and walking positions. Additionally program included vocal-breathing exercises and massage. Patients received 20 sessions for one hour at clinic for ten-week treatment period.

Other: body awareness therapy

Traditional exercises

ACTIVE COMPARATOR

Program included traditional exercises intended for strengthening back, abdominal, pelvis and shoulder girdle muscles and muscles in convex side of the curve, stretching exercises especially for the concave side of the curve, flexibility exercises for spine, postural training and breathing exercises. Patients received 20 sessions for one hour at clinic for ten-week treatment period.

Other: traditional exercises

core stabilization exercises

EXPERIMENTAL

Exercises started to progress from static to dynamic positions in which muscle activation incorporate into functional tasks including trunk and extremity movements. Local, global muscle stability training, global muscle mobility training and strengthening training of these core structure was carried out progressively advancing more difficult. Patients received 20 sessions for one hour at clinic for ten-week treatment period.

Other: core stabilization exercises

Interventions

body awareness therapy (BAT)
core stabilization exercises
Traditional exercises

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • patients who were diagnosed with idiopathic scoliosis
  • ages between 10 and 16 who were prescribed a brace

You may not qualify if:

  • Patients who did not accept to participate in the study or wear a spinal brace
  • congenital curve
  • neuromuscular, rheumatologic, renal, cardiovascular, pulmonary or vestibular diseases, tumors,
  • previous surgical correction or conservative therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Samanpazari, 06100, Turkey (Türkiye)

Location

Related Publications (20)

  • Romano M, Minozzi S, Zaina F, Saltikov JB, Chockalingam N, Kotwicki T, Hennes AM, Negrini S. Exercises for adolescent idiopathic scoliosis: a Cochrane systematic review. Spine (Phila Pa 1976). 2013 Jun 15;38(14):E883-93. doi: 10.1097/BRS.0b013e31829459f8.

    PMID: 23558442BACKGROUND
  • Yang JH, Suh SW, Sung PS, Park WH. Asymmetrical gait in adolescents with idiopathic scoliosis. Eur Spine J. 2013 Nov;22(11):2407-13. doi: 10.1007/s00586-013-2845-y. Epub 2013 Jun 4.

    PMID: 23732766BACKGROUND
  • Shneerson JM, Madgwick R. The effect of physical training on exercise ability in adolescent idiopathic scoliosis. Acta Orthop Scand. 1979 Jun;50(3):303-6. doi: 10.3109/17453677908989771.

    PMID: 474101BACKGROUND
  • Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.

    PMID: 24047455BACKGROUND
  • Maruyama T, Grivas TB, Kaspiris A. Effectiveness and outcomes of brace treatment: a systematic review. Physiother Theory Pract. 2011 Jan;27(1):26-42. doi: 10.3109/09593985.2010.503989.

    PMID: 21198404BACKGROUND
  • Negrini S, Minozzi S, Bettany-Saltikov J, Chockalingam N, Grivas TB, Kotwicki T, Maruyama T, Romano M, Zaina F. Braces for idiopathic scoliosis in adolescents. Cochrane Database Syst Rev. 2015 Jun 18;2015(6):CD006850. doi: 10.1002/14651858.CD006850.pub3.

    PMID: 26086959BACKGROUND
  • Negrini S, Fusco C, Minozzi S, Atanasio S, Zaina F, Romano M. Exercises reduce the progression rate of adolescent idiopathic scoliosis: results of a comprehensive systematic review of the literature. Disabil Rehabil. 2008;30(10):772-85. doi: 10.1080/09638280801889568.

    PMID: 18432435BACKGROUND
  • 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
  • Muthukrishnan R, Shenoy SD, Jaspal SS, Nellikunja S, Fernandes S. The differential effects of core stabilization exercise regime and conventional physiotherapy regime on postural control parameters during perturbation in patients with movement and control impairment chronic low back pain. Sports Med Arthrosc Rehabil Ther Technol. 2010 May 31;2:13. doi: 10.1186/1758-2555-2-13.

    PMID: 20515453BACKGROUND
  • Cakrt O, Slaby K, Viktorinova L, Kolar P, Jerabek J. Subjective visual vertical in patients with idiopatic scoliosis. J Vestib Res. 2011;21(3):161-5. doi: 10.3233/VES-2011-0414.

    PMID: 21558641BACKGROUND
  • Alves de Araujo ME, Bezerra da Silva E, Bragade Mello D, Cader SA, Shiguemi Inoue Salgado A, Dantas EH. The effectiveness of the Pilates method: reducing the degree of non-structural scoliosis, and improving flexibility and pain in female college students. J Bodyw Mov Ther. 2012 Apr;16(2):191-8. doi: 10.1016/j.jbmt.2011.04.002. Epub 2012 Jan 5.

    PMID: 22464116BACKGROUND
  • Gur G, Dilek B, Ayhan C, Simsek E, Aras O, Aksoy S, Yakut Y. Effect of a spinal brace on postural control in different sensory conditions in adolescent idiopathic scoliosis: a preliminary analysis. Gait Posture. 2015 Jan;41(1):93-9. doi: 10.1016/j.gaitpost.2014.09.001. Epub 2014 Sep 16.

    PMID: 25262334BACKGROUND
  • Coelho DM, Bonagamba GH, Oliveira AS. Scoliometer measurements of patients with idiopathic scoliosis. Braz J Phys Ther. 2013 Mar-Apr;17(2):179-84. doi: 10.1590/S1413-35552012005000081.

    PMID: 23778766BACKGROUND
  • Sanders JO, Polly DW Jr, Cats-Baril W, Jones J, Lenke LG, O'Brien MF, Stephens Richards B, Sucato DJ; AIS Section of the Spinal Deformity Study Group. Analysis of patient and parent assessment of deformity in idiopathic scoliosis using the Walter Reed Visual Assessment Scale. Spine (Phila Pa 1976). 2003 Sep 15;28(18):2158-63. doi: 10.1097/01.BRS.0000084629.97042.0B.

    PMID: 14501929BACKGROUND
  • Monticone M, Ambrosini E, Cazzaniga D, Rocca B, Ferrante S. Active self-correction and task-oriented exercises reduce spinal deformity and improve quality of life in subjects with mild adolescent idiopathic scoliosis. Results of a randomised controlled trial. Eur Spine J. 2014 Jun;23(6):1204-14. doi: 10.1007/s00586-014-3241-y. Epub 2014 Feb 28.

    PMID: 24682356BACKGROUND
  • Rumsey N, Harcourt D. Body image and disfigurement: issues and interventions. Body Image. 2004 Jan;1(1):83-97. doi: 10.1016/S1740-1445(03)00005-6.

    PMID: 18089143BACKGROUND
  • Mehling WE, Wrubel J, Daubenmier JJ, Price CJ, Kerr CE, Silow T, Gopisetty V, Stewart AL. Body Awareness: a phenomenological inquiry into the common ground of mind-body therapies. Philos Ethics Humanit Med. 2011 Apr 7;6:6. doi: 10.1186/1747-5341-6-6.

    PMID: 21473781BACKGROUND
  • Bisdorff AR, Wolsley CJ, Anastasopoulos D, Bronstein AM, Gresty MA. The perception of body verticality (subjective postural vertical) in peripheral and central vestibular disorders. Brain. 1996 Oct;119 ( Pt 5):1523-34. doi: 10.1093/brain/119.5.1523.

    PMID: 8931577BACKGROUND
  • Seferiadis A, Ohlin P, Billhult A, Gunnarsson R. Basic body awareness therapy or exercise therapy for the treatment of chronic whiplash associated disorders: a randomized comparative clinical trial. Disabil Rehabil. 2016;38(5):442-51. doi: 10.3109/09638288.2015.1044036. Epub 2015 May 8.

    PMID: 25955823BACKGROUND
  • Danielsson L, Papoulias I, Petersson EL, Carlsson J, Waern M. Exercise or basic body awareness therapy as add-on treatment for major depression: a controlled study. J Affect Disord. 2014 Oct;168:98-106. doi: 10.1016/j.jad.2014.06.049. Epub 2014 Jul 5.

    PMID: 25043321BACKGROUND

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Gozde Gur, PhD

    research assistant and physiotherapist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 17, 2015

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

September 17, 2015

Record last verified: 2015-09

Locations