- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06806020
Effect Of Scientific Exercise Approach For Scoliosis Versus Barcelona Scoliosis Physical Therapy School On Correction Of Adolescent Idiopathic Scoliosis
Adolescent idiopathic scoliosis AIS is the usual diagnosis made in healthy children with a spinal curvature of unknown cause of least 10 degrees but less than 50 degrees. The primary aim of scoliosis management is to stop curvature progression. Anecdotally, the American Academy of Orthopedic Surgeons agree that PSSEs are often considered to produce just as successful of a patient outcome as does surgery.
SEAS has been described as a scoliosis-specific active self-correction technique performed without any external aids and incorporated into functional exercises, The primary goals of SEAS include enhanced posture control, posture rehabilitation, muscle endurance, spinal stability, self-correction, and development of balance stability. Treatment sessions are conducted at least twice a week for 40 minutes each.
Barcelona Scoliosis Physical Therapy School BSPTS method: based on the principles developed by Katharina Schroth, and is mainly used to treat patients with adolescent idiopathic scoliosis, some forms of congenital anteroposterior scoliosis deformities and such other as Scheuermann disease. The predecessor of BSPTS was founded in 1968 in Barcelona, Spain by physiotherapist Elena Salvá. It is a physiotherapy method that includes cognitive, sensory and kinesthetic retraining to improve scoliosis at a three dimensional level. All principles follow a complete posture correction pattern including the trunk, upper and lower limbs. High-intensity forces are applied to the exercises through isometric contractions, stretching and breathing exercises. In summary, the principles of the BSPTS Method as they appear in the international literature are: 3D postural correction, translation, rotation, sagittal expansions, Expansion / Contraction, Stabilization, Integration.
Studies have shown that the BSPTS methodology is also effective in stabilizing the progression of scoliosis. In a one-year study by Zapata and co-authors, the BSPTS group showed effective stabilization of the Cobb angle compared to the observation group.
There isn't any previous study comparing between effect of SEAS approach and BSPTS in treating AIS.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Scoliosis is a three-dimensional spinal abnormality. The most prevalent form of scoliosis is adolescent idiopathic scoliosis AIS. Usually between the ages of 10 and 16. The majority of patients frequently report the first sign of spinal rotation. The thoracic cage's asymmetry and uneven shoulder height follow, along with other abnormalities like razor back, pelvic tilt, falling height, and uneven lower limb length. In extreme situations, movement imbalance and cardiopulmonary dysfunction may also arise. Additionally, because of changes in their physical appearance brought on by the condition, people with AIS may face psychological problems, such as feelings of inadequacy and the possible emergence of psychological disorders. AIS is now a well-known condition that hinders development and growth.
After ruling out all other possible causes of scoliosis, idiopathic scoliosis is determined. Only 0.3% to 0.5% of adolescents with adolescent idiopathic scoliosis AIS, which affects 2% to 3% of the population, will have a curvature of greater than 20 degrees, the magnitude of the curve at which treatment is typically advised. The risk of advancement is highest at the onset of puberty. According to the Heuter-Volkmann principle loading affects vertebral development. In order to better develop conservative treatment for spinal deformity it's better to start during the adolescent growth.
A thorough treatment plan is necessary for the conservative therapy of idiopathic scoliosis because of its complex pathomechanism. Using physiotherapeutic scoliosis-specific exercises PSSE is one of the best ways to address scoliosis. For all schools and techniques that have been approved by the SOSORT, the phrase physiotherapeutic scoliosis-specific exercises PSSE is used. Every approach and school shares a common goal and applies the SOSORT guidelines' tenets. Scientific evidence must serve as the foundation for a PSSE physiotherapy approach that is tailored to each patient. According to the SOSORT consensus, 3D self-correction ranks top among the crucial components that should be incorporated into the exercises . Self-correction is the process by which a patient looks for the optimal alignment they may attain in the three spatial planes.
The BSPTS is the physiotherapy method integrated into the rehabilitation approach used in the 'Elena Salva Institute' in Barcelona, Spain. BSPTS is physiotherapy method that can be defined as a therapy plan of cognitive, sensory-motor and kinaesthetic training which teaches the patient to improve her/his scoliosis posture and soft tissue imbalance, utilizing the assumption that scoliosis posture and soft tissue imbalance promote curve progression. The BSPTS recognizes the importance of multidisciplinary team approach to treat scoliosis which should include medical doctor, physiotherapist, orthotist and psychologist.
The SEAS approach originates from Lyon, some of the base characteristics previously published for the Lyon approach have been retained in SEAS: increasing patient's awareness of the deformity, emphasizing an independent auto-correction by the patient, use of exercises in which balance reactions are elicited. The most important differences gradually developed by SEAS, that made it different from the Lyon approach, include: active three-dimensional self-correction instead of the former auto-elongation, spinal stabilization concept according to the actual physiotherapeutic literature, research of an automatic correct reflex response, namely, a subconscious self-correction which should help to obtain the better integration in the daily life. focus on the cognitive-behavioral approach of the patient to increase compliance to treatment, variability of exercises stimuli instead of absolute repetitive precision of movements, according to modern neurophysiologic knowledge.
Self-correction can be defined as the search for the best possible alignment the patient can achieve in the three spatial planes. Three-dimensional self-correction is considered one of the most important elements for the organization of conservative treatment. The SOSORT (International Society on Scoliosis Orthopedic and Rehabilitation Treatment) consensus in 2005 attributes to the "3D Self-correction" first place in the ranking of important elements to be included in the exercises, The goal of SEAS exercises is to develop an automatic reaction to reaching a more appropriate posture which will encourage the maintenance of a three-dimensionally corrected posture while engaging in daily activities.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gharbia Governorate
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Tanta, Gharbia Governorate, Egypt
- Huda Mohamed Hashad
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- angle of scoliosis < 30,
- Risser sign of 0-3,
- not participating in other treatment during study
- not using braces.
Exclusion Criteria:
- scoliosis due to congenital, neuromuscular, or syndromic etiology,
- true leg length discrepancy,
- cardiac anomalies, kyphosis, asthma, and other pulmonary diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: group (1)
SEAS approach
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The SEAS approach provides a thorough evaluation of the patient before the treatment starts. In addition to the usual measurements for the specific assessment of the scoliosis (Cobb degrees, Bunnel, trunk decompensation, sagittal postural structure and aesthetic parameters), the patient performs a series of tests. The objectives are: assessment of physical conditions (strength and elasticity of certain muscle areas that are more likely 6 influence the structure of the pelvis and the spine), assessment of neuromotor ability related to the alignment of the spine and the pelvis (balance, management of body movements with closed eyes, optical/manual skills) (Romano et al, 2015). The main aim of SEAS is to reverse the Stokes vicious cycle, so, the abnormal loading created by the scoliosis with an asymmetric growth leading to worsening of curves that will lead to further asymmetric growth due to increased asymmetrical loading (ettany et al 2014). The goal of SEAS exercises is to develop an a |
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Experimental: group (2)
BSPTS school
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Barcelona scoliosis physical therapy school (BSPTS): Based on the theory that scoliosis posture promotes curve progression, according to the "vicious cycle" model, Barcelona Scoliosis Physical Therapy School (BSPTS) is a physiotherapeutic method that can be defined as a therapy plan of cognitive, sensory-motor, and kinesthetic training to teach the patient to improve their scoliosis 3D posture and shape.
The BSTPS method aims to: 1) improve aesthetics and correct scoliotic posture; 2) stabilize the spine and stop the progression of the curve; 3) inform patients and their families about the condition and available treatments; 4) enhance breathing; 5) increase activity, including daily living activities and functional mobility; 6) enhance general self-image and self-esteem; and 7) reduce pain.
The initial ideas serve as the foundation for BSPTS correctional Principles (Berdishevsky et al 2016).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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change of cobbs angle
Time Frame: after 6 months of treatment
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by x-ray assessment of cobbs angle to know the change of the scoliosis curvature
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after 6 months of treatment
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change of sagittal and coronal imbalance
Time Frame: after 6 months of treatment
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laser line machine will be used to assess changes of imbalance of sagittal and coronal
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after 6 months of treatment
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changes of angle of trunk rotation
Time Frame: after 6 months of treatment
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scoliometer is used to assess angle of trunk rotation
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after 6 months of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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assess quality of life
Time Frame: after 6 months of treatment
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SRS-22r patient Questionnaire used to assess quality of life
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after 6 months of treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed Bedair Ebrahim, professor of physical therapy, kafr-elsheikh university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-404
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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