Clinical trial NCT02552615: 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
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: scoliosis, verticality perception, body symmetry
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2015-09-17
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: cobb angle
timeFrame: 10 weeks
Secondary outcomes:
measure: Posterior Trunk Asymmetry Index (POTSI)
timeFrame: 10 weeks
measure: axial trunk rotation
timeFrame: 10 weeks
measure: Walter Reed Visual Assessment Scale (WRVAS)
timeFrame: 10 weeks
measure: SRS-22 Questionnaire
timeFrame: 10 weeks
measure: vertical perception
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Samanpazari
Study officials:
affiliation: research assistant and physiotherapist
name: Gozde Gur, PhD
role: PRINCIPAL_INVESTIGATOR
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