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Active Not Recruiting NCT07430098

Feedback-Based Balance Training for Adolescents With Idiopathic Scoliosis

Conditions: Adolescent Idiopathic Scoliosis, Postural Balance

Sex: All
Ages: 10 Years – 17 Years
Healthy volunteers: No
Phase: NA
Enrollment: 72
Sponsor: Ankara Etlik City Hospital

Location: Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation Ankara Yenimahalle

Summary

Adolescent idiopathic scoliosis (AIS) is the most common form of scoliosis occurring during the growth period and is associated with significant alterations in postural balance compared with healthy peers. Prior research has shown that adding sensorimotor or balance-focused training to scoliosis-specific exercises may produce greater improvements in postural control and overall balance function than scoliosis-specific exercises alone. However, no study has previously investigated the effects of feedback-based balance training using a multi-axial platform with real-time biofeedback (the HUBER® 360 Evolution system) in this population. The aim of this study is to evaluate the effect of adding HUBER® 360-based feedback balance training to individualized conservative scoliosis exercises on postural balance, postural symmetry, and health-related quality of life in adolescents with AIS. The intervention protocol consists of 12 sessions delivered over 4 weeks, three sessions per week. Each session comprises 40 minutes of individualized conservative scoliosis exercises (identical between arms) followed by 30 minutes of balance training that differs between arms: HUBER® 360-based feedback balance training delivered in the clinic in the intervention arm, and a structured home-based balance exercise program performed independently after physiotherapist instruction in the active comparator arm. Outcomes are assessed at three time points: T0 (baseline, week 0), T1 (immediately post-intervention, week 4), and T2 (12-week follow-up, week 16 from baseline). The primary outcome is the Stability Index measured by the TecnoBody ProKin stabilometric platform. Pre-specified key secondary outcomes include mediolateral standard deviation of the center of pressure, Romberg area ratio, Limits of Stability, the Scoliosis Research Society-22 Patient Questionnaire (SRS-22) total score, and single-leg stance time. Additional exploratory outcomes include further static, dynamic, and proprioceptive balance parameters from the TecnoBody ProKin platform; postural asymmetry parameters from the DIERS Formetric 4D rasterstereography system; and SRS-22 subdomain scores.

Eligibility Criteria

Inclusion Criteria: * Age between 10 and 17 years * Diagnosis of adolescent idiopathic scoliosis confirmed by a specialist physiatrist * No history of brace treatment * Radiological evaluation showing a Cobb angle between 10° and 25° Exclusion Criteria: * Congenital scoliosis * Neuromuscular scoliosis * History of spinal surgery (including procedures involving paravertebral muscles or other spinal operations) * Presence of metabolic bone disease affecting skeletal structure * Severe autoimmune or endocrinological disease * Connective tissue disorder or skeletal dysplasia * Mental retardation preventing comprehension of simple instructions * Advanced peripheral joint disease * Coexisting polyneuropathy * Coexisting myopathy * Central nervous system disease that may affect balance * History of abdominal surgery or abdominal trauma * Presence of additional chronic comorbidities * Lack of parental consent for participation in the study * Functional scoliosis * Current or prior brace use

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07430098). StuddyBuddy aggregates publicly available trial information.