- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07601893
Effects of Core Stabilization Exercises and Rotation Angular Breathing Exercises Among Idiopathic Scoliosis Patients (CSE RAB IS)
Effects of Core Stabilization Exercises and Rotational Angular Breathing Exercises on Cobb's Angle, Trunk Rotation, Inspiratory Capacity and Spinal Appearance Among Idopathic Scoliosis Patients
This study is a single-blind, two-arm parallel-group randomized controlled trial designed to evaluate the effects of core stabilization exercises combined with rotational angular breathing exercises on adolescents with idiopathic scoliosis. Participants aged 10-18 years with a Cobb angle between 10° and 25° will be randomly assigned to either an experimental group receiving a structured exercise program or a control group receiving standard care.
The intervention will be conducted over 12 weeks, with outcomes assessed at baseline, post-intervention, and follow-up periods. Primary outcomes include Cobb angle, angle of trunk rotation, inspiratory capacity, and spinal appearance. The study aims to determine whether the combined exercise approach is more effective than standard care in improving spinal alignment, respiratory function, and physical appearance.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity characterized by lateral curvature and vertebral rotation, commonly developing during adolescence. It is associated with postural asymmetry, trunk deformity, reduced pulmonary function, and decreased quality of life. Conservative management strategies, particularly exercise-based interventions, are widely used to prevent progression and improve functional outcomes.
Core stabilization exercises focus on strengthening the muscles surrounding the spine, including abdominal, paraspinal, and pelvic muscles. These exercises enhance spinal stability, improve postural control, and reduce compensatory movement patterns. However, core stabilization alone may not fully address thoracic asymmetry and respiratory limitations associated with scoliosis.
Rotational angular breathing exercises are scoliosis-specific techniques aimed at improving thoracic expansion, promoting spinal de-rotation, and enhancing pulmonary function. These exercises involve controlled breathing patterns that target the concave side of the rib cage, facilitating improved ventilation and postural correction.
Although both interventions have shown individual effectiveness, limited evidence exists regarding their combined effects on structural, functional, and patient-reported outcomes in adolescents with idiopathic scoliosis. Therefore, this study aims to evaluate the combined impact of core stabilization and rotational angular breathing exercises on multiple clinical outcomes.
This study will be conducted as a single-blind, randomized controlled trial with two parallel groups. A total of 32 participants meeting eligibility criteria will be recruited and randomly assigned in a 1:1 ratio to either the experimental group or the control group.
Participants in the experimental group will undergo a supervised exercise program consisting of core stabilization exercises (planks, bridges, bird dog, and dead bug) combined with rotational angular breathing exercises. The program will be performed 3-4 times per week for 12 weeks, with gradual progression in intensity and duration. The control group will receive standard care without a structured exercise program.
Outcome measures will be assessed at baseline, immediately after the 12-week intervention, and at 3-month and 6-month follow-up periods. Primary outcomes include Cobb angle measured via radiographs, angle of trunk rotation assessed using a scoliometer, inspiratory capacity measured using spirometry, and spinal appearance evaluated using the Spinal Appearance Questionnaire. Secondary outcomes include quality of life assessed using the Scoliosis Research Society-22 questionnaire.
Blinding will be applied at the level of outcome assessors to reduce measurement bias. Statistical analysis will be conducted to compare within-group and between-group differences over time.
The results of this study are expected to provide evidence on the effectiveness of a combined exercise approach targeting both biomechanical and respiratory components of scoliosis. This may support the development of comprehensive rehabilitation protocols for adolescents with idiopathic scoliosis.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Umber Nawaz, Phd Scholar
- Telefonní číslo: +92 3334888279
- E-mail: umber.nawaz@ubas.edu.pk
Studijní záloha kontaktů
- Jméno: Usama Ahmad, MS Physical Therapy
- Telefonní číslo: +92 3013115017
- E-mail: ua950366@gmail.com
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán, 5400
- General hospital lahore
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Kontakt:
- Dr. Ijaz Ahmad Burq, PhD PT
- Telefonní číslo: +92 334615892
- E-mail: burq802@yahoo.com
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Lahore, Punjab Province, Pákistán, 5400
- Ghurki trust and teaching hospital lahore
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Kontakt:
- Prof. Hafiz Muhammad Asim, PhD
- Telefonní číslo: +92 3009400346
- E-mail: info@hafizasim.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Adolescents aged 10-17 years
- Both male and female participants
- Diagnosed cases of idiopathic scoliosis
- Cobb's angle between 10° and 25°
- Both thoracic and lumbar spine scoliosis patients
- Both C-shaped or S-shaped curve scoliosis patients
Exclusion Criteria:
- Previous spinal surgery
- Significant neuromuscular disorders (e.g, muscular dystrophy, cerebral palsy)
- Other medical conditions affecting participation (e.g, respiratory or cardiac)
- Any contraindication to exercise program
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Core stabilization and rotational angular breathing exercises
Planks involve maintaining a straight body position from head to heels while resting on the forearms and toes, effectively strengthening the abdominal muscles and lower back.
Bridges require participants to lie on their backs with knees bent and feet flat, lifting their hips to create a straight line from shoulders to knees, targeting the glutes and hamstrings for enhanced pelvic stability.
The bird dog exercise is performed on hands and knees, where participants extend one arm and the opposite leg, promoting balance and coordination while engaging the core.
Lastly, dead bugs involve lying on the back with arms and legs raised, lowering one arm and the opposite leg while keeping the lower back pressed into the floor, which effectively engages deep core muscles.
Additionally, the program will incorporate rotational angular breathing exercises, focusing on enhancing thoracic expansion and postural control through specific breathing techniques.
|
Core stabilization exercises: planks, bridges, bird dog, and dead bug Rotational angular breathing exercises: emphasizing thoracic expansion, asymmetric rib cage mobility, and postural correction through controlled inhalation and prolonged exhalation All exercises will be performed under supervised conditions initially, with emphasis on neuromuscular control, spinal stability, and coordinated breathing. Each session will last 40 minutes, including: 3 sessions per week 12-week intervention period 5 minutes warm-up 25 minutes core stabilization exercises 10 minutes rotational angular breathing exercises • Cool-down and postural awareness exercises |
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Aktivní komparátor: Standard care
Participants in the active comparator group will receive conventional physiotherapy routinely provided for individuals with idiopathic scoliosis. The program will focus on general posture correction, flexibility, spinal mobility, and basic strengthening exercises without specialized core stabilization or rotational angular breathing techniques. Standard Care Intervention: General stretching exercises for trunk and lower limb muscles Active range of motion exercises for spinal mobility Conventional postural correction exercises Basic strengthening exercises for back and abdominal muscles Breathing awareness exercises without rotational angular emphasis Education regarding posture maintenance and ergonomic advice Frequency: 3 sessions per week Total Duration: 12 weeks Session Duration: 40 minutes Session Structure 5 minutes warm-up 25 minutes conventional physiotherapy exercises 5 minutes breathing and relaxation exercises 5 minutes cool-down and posture education |
Participants in the control group will receive conventional physiotherapy management routinely used for idiopathic scoliosis. The intervention will focus on posture correction, spinal mobility, flexibility, general strengthening, and breathing awareness exercises without specialized core stabilization or rotational angular breathing techniques. The program will include: Warm-up exercises Stretching exercises for trunk and lower limb muscles Spinal mobility exercises Basic abdominal and back strengthening exercises Postural correction and ergonomic education Diaphragmatic breathing and relaxation exercises Cool-down exercises Sessions will be supervised initially by a physiotherapist to ensure correct technique and safety. Frequency and Duration 3 sessions per week 12-week intervention period 40 minutes per session Session Structure 5 minutes warm-up 25 minutes conventional physiotherapy exercises 5 minutes breathing exercises 5 minutes cool-down and posture education |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cobb's angle
Časové okno: 12 Weeks
|
Cobb angle is a radiographic measure used to quantify the degree of spinal curvature in scoliosis. It is measured by identifying the most tilted vertebrae at the upper and lower ends of the curve on an anteroposterior spinal radiograph and calculating the angle between intersecting perpendicular lines drawn from these vertebrae. Time Frame: Baseline, 4 weeks, 8 weeks and 12 weeks |
12 Weeks
|
|
Trunk rotation
Časové okno: 12 weeks
|
Angle of Trunk Rotation (ATR) is assessed using a scoliometer during the Adam's Forward Bend Test. The device is placed over the spine at the point of maximum deformity to quantify axial trunk rotation and rib hump prominence. Time Frame: Baseline, 4 weeks, 8 weeks and 12 weeks |
12 weeks
|
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Inspiratory capacity
Časové okno: 12 weeks
|
Inspiratory capacity is defined as the maximum volume of air that can be inhaled after a normal expiration. It is measured using spirometry with a calibrated spirometer to assess pulmonary function and thoracic expansion. Time Frame: Baseline, 4 weeks, 8 weeks and 12 weeks |
12 weeks
|
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Spinal appearance
Časové okno: 12 weeks
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The Spinal Appearance Questionnaire (SAQ) is a patient-reported outcome measure that evaluates the perception of spinal deformity and cosmetic appearance. It includes domains related to trunk asymmetry, curve perception, and self-image. Time Frame: Baseline, 4 weeks, 8 weeks and 12 weeks |
12 weeks
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Prof. Shoaib Waqas, Phd, Lahore University of Biological and Applied Sciences
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UBAS/ERB/26/04/035
- U1111-1339-6644 (Identifikátor registru: WHO, ICTRP)
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
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Studuje lékový produkt regulovaný americkým FDA
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