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Effectiveness of Exercises in Adolescent Idiopathic Scoliosis

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
body awareness therapy
core stabilization exercises
traditional exercises
Sponsored by
Gözde Gür
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring scoliosis, verticality perception, body symmetry

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

body awareness therapy (BAT)

Traditional exercises

core stabilization exercises

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Posterior Trunk Asymmetry Index (POTSI)
POTSI is a surface topography method, which scores body shape and asymmetry objectively. The measurements of patient's back were taken for the calculation of the score POTSI is composed of six index including frontal asymmetry index (FAI), height differences index (HDI) for shoulder, axilla and trunk regions. Total score is a sum of these six indexes.
axial trunk rotation
Axial trunk rotations (ATR) were assessed with scoliometer in Adam's forward bend test
Walter Reed Visual Assessment Scale (WRVAS)
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). Total score is an average of these 7 domains
SRS-22 Questionnaire
It assess quality of life in scoliosis. This instrument consists of six domains including function, pain, self-image, mental health, satisfaction/dissatisfaction which are scored from 1 (best answer) to 5 (worst answer) each question
vertical perception
All visual (SVV), postural (SPV) and haptic (SHV) subjective vertical perception tests were performed using manually controlled laser liner device by the therapist in a darkened, silent and empty room. The therapist put laser line as deviated from vertical, then turned it to vertical slowly and asked patient to find true earth vertical. Subjects were instructed to tell "stop" when they thought it is correct angle for them. Assessment were repeated for horizontal line and at the angles of 30°, 45°, 60° left and 30°, 45°, 60° right (according to the ground). This test expressed SVV assessment. For SPV patient predict angle with his/her hand position. For SHV, patients predict angle by holding a wooden stick with their hands.

Full Information

First Posted
September 15, 2015
Last Updated
September 15, 2015
Sponsor
Gözde Gür
Collaborators
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT02552615
Brief Title
Effectiveness of Exercises in Adolescent Idiopathic Scoliosis
Official Title
Investigation of the Effects of Spinal Stabilization and Body Awareness Exercises on Subjective Vertical Perception, Curve Magnitude, Body Symmetry and Quality of Life in Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gözde Gür
Collaborators
Hacettepe University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
In patients with idiopathic scoliosis (IS), in addition to curve progression there are many problems including altered posture, gait deviations, muscular imbalance, functional limitations, back pain, negative physico-social, body image effects, and in severe cases pulmonary symptoms commonly occur. To cope with these complications and more, conservative treatment of adolescent idiopathic scoliosis (AIS) involves a variety of bracing methods and exercises. Spinal bracing is an important treatment option to prevent curve progression in moderate curves (between 20-40) and severe curves in AIS. Bracing success rate is reported 80% in the long term but the level of evidence is still low. In literature, exercises are recommended to reduce progression, to improve spine and thoracic cage flexibility, muscle elasticity and strength, to correct postural behavior, and neuro-motor control, spine stability. In general, traditional exercises (TE) including stretching, strengthening exercises for spinal musculature, postural training, respiratory exercises have been used for many years for IS. Besides traditional exercises, there are several exercise concepts including SEAS, Schroth, Dobomed, Side Shift methods... etc. Effectiveness of exercise is still in debate and there is need for further studies, which investigate the role of specific exercises for scoliosis in conservative treatment. In scoliosis, muscle imbalances, the deficiency of muscle ability to stabilize posture, the loss in balance of pelvis-spine relation due to lateral tilt of the body and postural control impairment resulting from these problems are defined. In addition, the tree dimensional scoliotic deformity cause sensory disturbances, standing instability and gait modifications. Core stabilization exercises (CSE) are described as therapy technique that improve neuromuscular control, strength of trunk stabilization muscles, endurance of postural muscles, trunk mobilization muscles around spine, balance between pelvis and spine in order to maintain functional stability and postural control. It was indicated in the literature that patients with AIS exhibit disturbances of vertical perception. Postural vertical line is important for a person to perceive body orientation in space and thereby to provide and maintain upright posture and gait. Body Awareness Therapy (BAT) is a mind-body approach, which aims to improve body awareness, body posture, quality of movements, balance, postural control integrating with slow movement co-ordination and breathing exercises. BAT programs also contain stretching exercises, relaxing exercises and gait training. Patients are instructed to concentrate body vertical line and all movements are thought to initiate from body center. BAT have been studied in many medical conditions including back pain, anxiety, fibromyalgia, eating disorders, heart diseases, falls in elderly. However, there are limited studies determining CSE effects on patients with scoliosis: one have reported improvement in Cobb's angle and pain and the other in sitting balance with lumbar stabilization exercises. There was no research examining the effects of BAT in scoliosis. However for the reasons mentioned above, we hypothesized that CSE and BAT therapies can have positive effects on postural re-alignment and trunk deformity in patients with AIS. The aim of this study was to investigate the effects of core stabilization and body awareness exercises versus traditional exercises in addition to brace wearing on vertical perception, trunk asymmetry, cosmetic deformity and health related quality of life in patients with AIS. The aim of this study was to compare the effects of spinal stabilization and body awareness exercises in addition to brace wearing versus traditional exercises on subjective verticality perception, trunk symmetry, cosmetic deformity and health related quality of life in Adolescent idiopathic scoliosis (AIS). This study included 30 AIS patients between the ages of 14,40 ± 2,01 years (stabilization group), 14,2 ± 2 years (Body awareness group) ve 13,60 ± 1,65 (classical group). Following recording demographic data, bone maturation level according to Riser, curve types according to King, spinal region, which includes curve, were recorded. Cobb angles by antero-posterior X-ray, rotation degrees with scoliometer in Adam's forward bend test, subjective visual (SVV), postural (SPV) and haptic (SHV) verticality perception with laser stick system, cosmetic deformity perception for patient, family and physiotherapist according with Walter Reed Visual Assessment Scale (WRVAS), trunk asymmetries with Posterior Trunk Asymmetry Index (POTSI) and health related quality of life with SRS-22 were assessed at baseline and after 10th week of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
scoliosis, verticality perception, body symmetry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
body awareness therapy (BAT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional exercises
Arm Type
Active Comparator
Arm Description
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.
Arm Title
core stabilization exercises
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
body awareness therapy
Intervention Type
Other
Intervention Name(s)
core stabilization exercises
Intervention Type
Other
Intervention Name(s)
traditional exercises
Primary Outcome Measure Information:
Title
cobb 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
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Posterior Trunk Asymmetry Index (POTSI)
Description
POTSI is a surface topography method, which scores body shape and asymmetry objectively. The measurements of patient's back were taken for the calculation of the score POTSI is composed of six index including frontal asymmetry index (FAI), height differences index (HDI) for shoulder, axilla and trunk regions. Total score is a sum of these six indexes.
Time Frame
10 weeks
Title
axial trunk rotation
Description
Axial trunk rotations (ATR) were assessed with scoliometer in Adam's forward bend test
Time Frame
10 weeks
Title
Walter Reed Visual Assessment Scale (WRVAS)
Description
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). Total score is an average of these 7 domains
Time Frame
10 weeks
Title
SRS-22 Questionnaire
Description
It assess quality of life in scoliosis. This instrument consists of six domains including function, pain, self-image, mental health, satisfaction/dissatisfaction which are scored from 1 (best answer) to 5 (worst answer) each question
Time Frame
10 weeks
Title
vertical perception
Description
All visual (SVV), postural (SPV) and haptic (SHV) subjective vertical perception tests were performed using manually controlled laser liner device by the therapist in a darkened, silent and empty room. The therapist put laser line as deviated from vertical, then turned it to vertical slowly and asked patient to find true earth vertical. Subjects were instructed to tell "stop" when they thought it is correct angle for them. Assessment were repeated for horizontal line and at the angles of 30°, 45°, 60° left and 30°, 45°, 60° right (according to the ground). This test expressed SVV assessment. For SPV patient predict angle with his/her hand position. For SHV, patients predict angle by holding a wooden stick with their hands.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients who were diagnosed with idiopathic scoliosis ages between 10 and 16 who were prescribed a brace Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gozde Gur, PhD
Organizational Affiliation
research assistant and physiotherapist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
State/Province
Samanpazari
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

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Effectiveness of Exercises in Adolescent Idiopathic Scoliosis

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