search
Back to results

Exercises in Adolescent Idiopathic Scoliosis

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Schroth Exercises
Core stabilization Exercises
Sponsored by
Karamanoğlu Mehmetbey University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Adolescent Idiopathic Scoliosis, Scoliosis, Exercise

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having a diagnosis of adolescent idiopathic scoliosis,
  • A Cobb angle of 10 to 30 degrees
  • Having Lenke type 1 curve
  • No other treatment which might affect scoliosis

Exclusion Criteria:

  • Non-idiopathic scoliosis
  • Prescribed brace
  • Surgical correction history
  • Who were unable to participate in the supervised sessions,or those who refused to follow treatment were excluded.
  • Contraindications to exercise -Accompanying mental problems, neurological- muscular or rheumatic diseases,

Sites / Locations

  • Karamanoglu Mehmetbey University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Schroth group

Stabilization group

Arm Description

The Schroth group received Schroth exercises in addition to traditional rehabilitation.

The stabilization group received core stabilization in addition to traditional rehabilitation.

Outcomes

Primary Outcome Measures

Cobb's 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. The Cobb angle is the angle from a posterior-anterior full spine radiographs between the upper endplate of the upper-end vertebra of the largest curve and the lower endplate of the lower end vertebra from the largest curve.

Secondary Outcome Measures

Trunk rotation angles
-Trunk rotation angles Axial trunk rotations (ATR) were assessed with a scoliometer in Adam's forward bend test.
Muscle strength
Muscle strengths were assessed by a Biodex System 4-Pro dynamometer (Biodex, Inc., Shirley, New York). Upper extremity pattern strengths (flexion-abduction-external rotation / extension-adduction-internal rotation), and quadriceps, hamstring muscles strengths were assessed in both extremity. The outcome parameter was the peak torque (expressed in Nm) which was normalized to the participants' body weight (expressed in Nm/kg) in an effort to reduce inter-subject variability in raw scores of quantitative muscle tests.
Spinal mobility
Spinal mobility was assessed with a new computer-aided skin-surface device (The Spinal Mouse® System, Idiag, Fehraltorf, Switzerland). Spinal Mouse is an external non-invasive measurement method developed to evaluate the motility and shape of the spine in many planes. The Spinal Mouse has acceptable metrological properties to assess segmental and global thoracal and lumbar mobility. Measurements were performed between spinous process of C7 and the top of the anal crease (approximately S3). Maximal extension, maximal flexion and maximal left and right lateral flexion positions were performed. The analysis of spinal mobility in the sagittal (SAP - maximal extension to flexion) and the coronal (CRP - maximal left to right flexion) plane was evaluated.
Cosmetic trunk deformity
Walter Reed Visual Assessment Scale (WRVAS) was used to assess cosmetic deformity. The domains of WRVAS are body curve, rib prominence, flank prominence, head rib pelvis, head pelvis, shoulder level, and scapular rotation. Each domain generates a score from 1 (best deformity) to 5 (worst deformity). The total score is an average of these 7 domains.
SRS-22 Questionnaire
The SRS-22 questionnaire assesses the quality of life in scoliosis. It is a self-reported tools assessing self-image, function, pain, mental health with 5 questions each and satisfaction with care with 2 questions which are scored from 1 (best answer) to 5 (worst answer) each question. A total score is based on all 22 questions and an average of these 7 domains.

Full Information

First Posted
May 12, 2020
Last Updated
November 25, 2020
Sponsor
Karamanoğlu Mehmetbey University
search

1. Study Identification

Unique Protocol Identification Number
NCT04421157
Brief Title
Exercises in Adolescent Idiopathic Scoliosis
Official Title
The Effectiveness of Two Different Exercises in Adolescent Idiopathic Scoliosis: A Single-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 17, 2019 (Actual)
Primary Completion Date
January 28, 2020 (Actual)
Study Completion Date
March 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karamanoğlu Mehmetbey University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study was to investigate the effectiveness of two different exercises in adolescent idiopathic scoliosis. In total, 28 subjects with adolescent idiopathic scoliosis were randomly divided into two groups: Schroth (n = 14) and stabilization group (n = 14). The Schroth group received Schroth exercises in addition to traditional rehabilitation, and the stabilization group received core stabilization in addition to traditional rehabilitation for 10 weeks. The outcome measures were based on Cobb angle, angle of trunk rotation, spinal mobility, cosmetic trunk deformity, muscle strength, and quality of life.
Detailed Description
Adolescent idiopathic scoliosis (AIS) is a progressive growth disease with unknown etiology, characterized by a three-dimensional deformity of the spine (frontal translation, sagittal modification, and torsion of the spinous processes on the concave side of the scoliotic curve on radiographs). In patients with AIS, in addition to curve progression there are many problems commonly occur such as; muscular imbalance, functional limitations, altered posture, gait deviations, reduced flexibility of the spine, back pain, negative physico-social, body image effects, and in severe cases pulmonary symptoms. The asymmetry of the trunk and pelvis are affected related to the shape and angle of scoliosis, and the weight distribution position changes depending on the shape and the Cobb angle of scoliosis. To deal with these complications and more, various treatment approaches have been proposed for AIS, including exercise, bracing, casting, traction, biofeedback, surgery, and simple observation to prevent, correct or halt the progression of the deformity. Conservative treatment methods including physiotherapy and bracing are accepted in Central Europe. In literature, exercises are recommended to decrease progression, to improve spine and thoracic cage flexibility, muscle strengths, and elasticity, to correct postural behavior, and neuro-motor control, spine stability. In general, traditional exercises (TE) including postural training, stretching, and strengthening exercises for spinal musculature, respiratory exercises have been used for many years for scoliosis. Except for the traditional exercises, there are several exercise concepts including Schroth, Side Shift, Dobomed methods... etc. Schroth exercises are asymmetric scoliosis-specific postural exercises that aim to improve the curve, function, posture, self-image, and pain. Schroth exercises target strength and endurance training of the back, abdominal, and leg muscles. Also one of the aim of Schroth exercises is to improve motor control of the posture by repeating corrective movements with progressively less feedback. Schroth exercises are the most studied scoliosis exercises but there are limited randomized controlled studies on Schroth exercises. Recently general physiotherapeutic exercises including, Core stabilization (CS) exercises, Pilates have been used in the conservative treatment of idiopathic scoliosis. CS exercises are described as therapy techniques that improve postural control, and functional stability through increasing neuromuscular control, the strength of trunk stabilization muscles, the endurance of postural muscles around the spine, the balance between pelvis and spine. However, limited studies are determining CS exercises' effect on patients with AIS. In a study CS exercises found to be more effective in reducing pain and rotational deformity than traditional exercises in the conservative rehabilitation of AIS. A recent systematic review showed that therapeutic exercise had been effective to reduce symptoms, Cobb's angle, trunk rotation, craniovertebral angle, and body asymmetries, and to improve muscular endurance, pulmonary function, and functional capacity of patients with AIS. Corrective, therapeutic exercises appear to have positive effects by improving function and reducing symptoms, as well as various angles and body asymmetries. However, further studies with better methodological quality are required to confirm these outcomes and detect the best therapeutic exercise intervention. And also there is a need for randomized controlled studies on different methods of exercise to choose the most effective exercise in clinical practice. There was no research compared to the effects of the Schroth method and CS exercises in patients with AIS. And also there was no research examining the effects of the Schroth method on peripheral muscle strengths. This study aimed to investigate the effects of the Schroth versus CS exercises in addition to traditional exercises, on Cobb angle, trunk rotation, peripheral muscle strengths, spine mobility, cosmetic deformity, and health-related quality of life in patients with AIS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Adolescent Idiopathic Scoliosis, Scoliosis, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each patient selected a number in a closed envelope, which was sorted via the 'Research Randomiser' program for the randomisation process, and the patients were separated into the following two groups; Schroth group (n=14) and stabilization group (n=14)
Masking
Outcomes Assessor
Masking Description
Assessments were undertaken at baseline, and after the 10 week treatment period for each patient by the investigator, who was blind to the allocation of the participants.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Schroth group
Arm Type
Experimental
Arm Description
The Schroth group received Schroth exercises in addition to traditional rehabilitation.
Arm Title
Stabilization group
Arm Type
Experimental
Arm Description
The stabilization group received core stabilization in addition to traditional rehabilitation.
Intervention Type
Other
Intervention Name(s)
Schroth Exercises
Other Intervention Name(s)
Schroth Method, Scoliosis specific exercises
Intervention Description
The Schroth approach consists of 3D scoliosis-specific exercises based on kinesthetic and sensorimotor principles. The goal of Schroth exercises is to teach patients to consciously maintain the correct posture in daily living activities in order to improve the curve, pain, and self-image. The treatment program consists of scoliotic posture correction and a breathing pattern with the help of proprioceptive and exteroceptive stimulations and mirror control. Traditional exercises program included strengthening back, abdominal, pelvis and shoulder girdle muscles and also muscles in the convex side of the curve, stretching exercises especially for the concave side of the curve, postural training, flexibility exercises for the spine, and breathing exercises. Schroth group received Schroth exercises in addition to traditional rehabilitation for 10 weeks. Patients received 30 sessions for 90 minutes at the clinic for ten-week treatment period.
Intervention Type
Other
Intervention Name(s)
Core stabilization Exercises
Intervention Description
Each exercise session consisted of a warm-up exercise, core stabilization exercise, and a cool-down exercise. The core stabilization exercise was designed with consideration of local, global muscle stability training, global muscle mobility training,and strengthening training of these core structures was carried out progressively advancing more difficult. Traditional exercises program included strengthening back, abdominal, pelvis and shoulder girdle muscles and also muscles in the convex side of the curve, stretching exercises especially for the concave side of the curve, postural training, flexibility exercises for the spine, and breathing exercises. The Stabilization group received Core stabilization in addition to traditional rehabilitation for 10 weeks. Patients received 30 sessions for 90 minutes at the clinic for ten-week treatment period.
Primary Outcome Measure Information:
Title
Cobb's angle
Description
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. The Cobb angle is the angle from a posterior-anterior full spine radiographs between the upper endplate of the upper-end vertebra of the largest curve and the lower endplate of the lower end vertebra from the largest curve.
Time Frame
10 week
Secondary Outcome Measure Information:
Title
Trunk rotation angles
Description
-Trunk rotation angles Axial trunk rotations (ATR) were assessed with a scoliometer in Adam's forward bend test.
Time Frame
10 week
Title
Muscle strength
Description
Muscle strengths were assessed by a Biodex System 4-Pro dynamometer (Biodex, Inc., Shirley, New York). Upper extremity pattern strengths (flexion-abduction-external rotation / extension-adduction-internal rotation), and quadriceps, hamstring muscles strengths were assessed in both extremity. The outcome parameter was the peak torque (expressed in Nm) which was normalized to the participants' body weight (expressed in Nm/kg) in an effort to reduce inter-subject variability in raw scores of quantitative muscle tests.
Time Frame
10 week
Title
Spinal mobility
Description
Spinal mobility was assessed with a new computer-aided skin-surface device (The Spinal Mouse® System, Idiag, Fehraltorf, Switzerland). Spinal Mouse is an external non-invasive measurement method developed to evaluate the motility and shape of the spine in many planes. The Spinal Mouse has acceptable metrological properties to assess segmental and global thoracal and lumbar mobility. Measurements were performed between spinous process of C7 and the top of the anal crease (approximately S3). Maximal extension, maximal flexion and maximal left and right lateral flexion positions were performed. The analysis of spinal mobility in the sagittal (SAP - maximal extension to flexion) and the coronal (CRP - maximal left to right flexion) plane was evaluated.
Time Frame
10 week
Title
Cosmetic trunk deformity
Description
Walter Reed Visual Assessment Scale (WRVAS) was used to assess cosmetic deformity. The domains of WRVAS are body curve, rib prominence, flank prominence, head rib pelvis, head pelvis, shoulder level, and scapular rotation. Each domain generates a score from 1 (best deformity) to 5 (worst deformity). The total score is an average of these 7 domains.
Time Frame
10 week
Title
SRS-22 Questionnaire
Description
The SRS-22 questionnaire assesses the quality of life in scoliosis. It is a self-reported tools assessing self-image, function, pain, mental health with 5 questions each and satisfaction with care with 2 questions which are scored from 1 (best answer) to 5 (worst answer) each question. A total score is based on all 22 questions and an average of these 7 domains.
Time Frame
10 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having a diagnosis of adolescent idiopathic scoliosis, A Cobb angle of 10 to 30 degrees Having Lenke type 1 curve No other treatment which might affect scoliosis Exclusion Criteria: Non-idiopathic scoliosis Prescribed brace Surgical correction history Who were unable to participate in the supervised sessions,or those who refused to follow treatment were excluded. Contraindications to exercise -Accompanying mental problems, neurological- muscular or rheumatic diseases,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hikmet Kocaman, MSc
Organizational Affiliation
Karamanoğlu Mehmetbey University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karamanoglu Mehmetbey University
City
Karaman
ZIP/Postal Code
70200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23558442
Citation
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.
Results Reference
background
PubMed Identifier
474101
Citation
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.
Results Reference
background
PubMed Identifier
18432435
Citation
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.
Results Reference
background
PubMed Identifier
28033399
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.
Results Reference
background
PubMed Identifier
31286903
Citation
Schreiber S, Parent EC, Hill DL, Hedden DM, Moreau MJ, Southon SC. Patients with adolescent idiopathic scoliosis perceive positive improvements regardless of change in the Cobb angle - Results from a randomized controlled trial comparing a 6-month Schroth intervention added to standard care and standard care alone. SOSORT 2018 Award winner. BMC Musculoskelet Disord. 2019 Jul 8;20(1):319. doi: 10.1186/s12891-019-2695-9.
Results Reference
background
PubMed Identifier
30824243
Citation
Thompson JY, Williamson EM, Williams MA, Heine PJ, Lamb SE; ACTIvATeS Study Group. Effectiveness of scoliosis-specific exercises for adolescent idiopathic scoliosis compared with other non-surgical interventions: a systematic review and meta-analysis. Physiotherapy. 2019 Jun;105(2):214-234. doi: 10.1016/j.physio.2018.10.004. Epub 2018 Oct 27.
Results Reference
background
PubMed Identifier
30016036
Citation
Ceballos Laita L, Tejedor Cubillo C, Mingo Gomez T, Jimenez Del Barrio S. Effects of corrective, therapeutic exercise techniques on adolescent idiopathic scoliosis. A systematic review. Arch Argent Pediatr. 2018 Aug 1;116(4):e582-e589. doi: 10.5546/aap.2018.eng.e582. English, Spanish.
Results Reference
background
PubMed Identifier
27134403
Citation
Kim G, HwangBo PN. Effects of Schroth and Pilates exercises on the Cobb angle and weight distribution of patients with scoliosis. J Phys Ther Sci. 2016 Mar;28(3):1012-5. doi: 10.1589/jpts.28.1012. Epub 2016 Mar 31.
Results Reference
background
PubMed Identifier
12221357
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. doi: 10.1097/00007632-200209010-00018.
Results Reference
background
PubMed Identifier
14501929
Citation
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.
Results Reference
background
PubMed Identifier
23778766
Citation
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.
Results Reference
background
PubMed Identifier
22464116
Citation
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.
Results Reference
background
PubMed Identifier
20032022
Citation
Martinez-Llorens J, Ramirez M, Colomina MJ, Bago J, Molina A, Caceres E, Gea J. Muscle dysfunction and exercise limitation in adolescent idiopathic scoliosis. Eur Respir J. 2010 Aug;36(2):393-400. doi: 10.1183/09031936.00025509. Epub 2009 Dec 23.
Results Reference
background
PubMed Identifier
27625122
Citation
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.
Results Reference
background
PubMed Identifier
31658087
Citation
Ameer MA, Kamel MI, Elhafez YM. A comparison of sagittal spine deformities among elementary school students using spinal mouse device. Work. 2019;64(3):545-550. doi: 10.3233/WOR-193015.
Results Reference
background
PubMed Identifier
25900295
Citation
Livanelioglu A, Kaya F, Nabiyev V, Demirkiran G, Firat T. The validity and reliability of "Spinal Mouse" assessment of spinal curvatures in the frontal plane in pediatric adolescent idiopathic thoraco-lumbar curves. Eur Spine J. 2016 Feb;25(2):476-82. doi: 10.1007/s00586-015-3945-7. Epub 2015 Apr 22.
Results Reference
background
PubMed Identifier
29238754
Citation
Cheshire J, Gardner A, Berryman F, Pynsent P. Do the SRS-22 self-image and mental health domain scores reflect the degree of asymmetry of the back in adolescent idiopathic scoliosis? Scoliosis Spinal Disord. 2017 Dec 11;12:37. doi: 10.1186/s13013-017-0144-9. eCollection 2017.
Results Reference
background
PubMed Identifier
20979705
Citation
Tsai YT, Leong CP, Huang YC, Kuo SH, Wang HC, Yeh HC, Lau YC. The electromyographic responses of paraspinal muscles during isokinetic exercise in adolescents with idiopathic scoliosis with a Cobb's angle less than fifty degrees. Chang Gung Med J. 2010 Sep-Oct;33(5):540-50.
Results Reference
background
PubMed Identifier
20421854
Citation
Lin JJ, Chen WH, Chen PQ, Tsauo JY. Alteration in shoulder kinematics and associated muscle activity in people with idiopathic scoliosis. Spine (Phila Pa 1976). 2010 May 15;35(11):1151-7. doi: 10.1097/BRS.0b013e3181cd5923.
Results Reference
background
PubMed Identifier
33857180
Citation
Kocaman H, Bek N, Kaya MH, Buyukturan B, Yetis M, Buyukturan O. The effectiveness of two different exercise approaches in adolescent idiopathic scoliosis: A single-blind, randomized-controlled trial. PLoS One. 2021 Apr 15;16(4):e0249492. doi: 10.1371/journal.pone.0249492. eCollection 2021.
Results Reference
derived

Learn more about this trial

Exercises in Adolescent Idiopathic Scoliosis

We'll reach out to this number within 24 hrs