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Effects of Expiratory Muscle Strength Training in Adolescent Idiopathic Scoliosis

No phase Interventional Adolescent Idiopathic Scoliosis (AIS) Scoliosis; Adolescence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Expiratory Muscle Strength Training (EMST-150), Sham Training.
Who it may be relevant to
Registry conditions: Adolescent Idiopathic Scoliosis (AIS), Scoliosis; Adolescence. Basic parameters: 10 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Expiratory Muscle Strength Training on Cobb Angle, Respiratory Muscle Strength, Core Stabilization, Functional Exercise Capacity and Quality of Life in Adolescent Idiopathic Scoliosis

Overview

Adolescent idiopathic scoliosis result in deterioration of core muscles and respiratory system. Core muscles provide trunk stabilization as well as responsible for respiratory system. Especially tr. abdominis, rectus abdominis, external oblic and internal oblic muscle, which are core muscles, highly active during forced expiration while diaphragm muscle also active during inspiration. Thus, expiratory muscle strength training has effect not only respiratory muscle strength but also trunk stabilization. While, effects of expiratory muscle strength training in adolesecent idiopathic scoliosis is a topic that needs to be investigated, this topic has not been investigated until today. Hence, this current study aimed to investigate the effects of expiratory muscle strength training on cobb angle, respiratory muscle strength, core stabilization, functional exercise capacity and quality of life.

Detailed description

A convenience of children with adolescent idiopathic scoliosis, 10-19 years, is going to recruited from Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. Patients will randomly allocate to either a treatment group or control group. The treatments group will receive expiratory muscle strength training at 50% maximal expiratory presssure while, the control group will receive sham expiratory muscle strength training without physiological load. Groups are going to train for a total of 25 breathe/day, 5 days/week, for 6 weeks. Before and after treatment, all of patients progression of scoliosis will be evaluated by calculating cobb angle, respiratory muscle strength using with electronic mouth pressure device, core stability using with Mc-Gill endurance test and the stabilizer biofeedback unit, functional exercise capacity using with six minute walk test (6MWT) and six minute pegboard and ring test (6MPBRT), quality of life using with scoliosis research society -22 questionnare (SRS-22) and daily living activity of upper extremity using with quick-DASH questionnare.

Interventions

  • Device Expiratory Muscle Strength Training (EMST-150)
    Training is going to perform by using a pressure treshold-loading device (EMST-150, Aspire Products, LLC, Gainesville, FL) used to exhale against a same-pressure load every exhalation for strengthening primarily the core muscles. The device pressure is adjusted according to PEmax and reliability/reproducibility has been demonstrated.
  • Device Sham Training
    Training is going to perform by using a pressure treshold-loading device (EMST-150, Aspire Products, LLC, Gainesville, FL) without physiological load. The sham device closely resembled the EMST device, with the only difference being that the pressure release valve was rendered nonfunctional by removing the spring. As a result, it exerted minimal to no physiological load on the targeted muscles.

Primary outcome measures

  • Cobb Angle [Time frame: 6 Weeks]
Secondary outcome measures (7)
  • Respiratory Muscle Strength [Time frame: 6 Weeks]
  • McGill Endurance Test [Time frame: 6 Weeks]
  • '6 Minute Pegboard and Ring' Test [Time frame: 6 Weeks]
  • Scoliosis Research Society 22 Patient Questionnaire [Time frame: 6 Weeks]
  • Quick Disabilities of the Arm, Shoulder and Hand Questionnaire [Time frame: 6 Weeks]
  • The Stabilizer Pressure Biofeedback Unit [Time frame: 6 Weeks]
  • 6 Minute Walk Test [Time frame: 6 Weeks]

Eligibility criteria

Inclusion criteria

  • Individuals diagnosed with idiopathic scoliosis,
  • aged between 10 and 19 years,
  • with a Cobb angle ranging from 10 to 45 degrees.

Exclusion criteria

  • Individuals who have undergone spinal surgery,
  • who have received conservative or surgical treatment for scoliosis,
  • individuals with neurological, neuromuscular, systemic, rheumatological, or musculoskeletal disorders, or conditions affecting balance and walking,
  • individuals with a history of cardiac or pulmonary diseases that could affect respiratory function and exercise capacity.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation — Ankara

Identifiers

NCT: NCT06752993 · 02112001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗