Feedback-Based Balance Training for Adolescents With Idiopathic Scoliosis

NCT07430098 | Active Not Recruiting

• 1 other identifier: AEŞH-EK-2025-0136
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adolescent Idiopathic Scoliosis; Postural Balance

Keywords

HUBER® 360; Adolescent Idiopathic Scoliosis; Balance Training; Physical Therapy Rehabilitation; TecnoBody Balance System; DIERS Formetric 4D; Postural Balance; Rasterstereography; Postural Control; Scoliosis Exercises; Individualized Conservative Scoliosis Exercises

Outcome Measures

Primary Outcomes (1)

• Change in Stability Index measured by the TecnoBody balance system

  The primary outcome is the change in the Stability Index measured by the TecnoBody ProKin PK252 stabilometric platform (TecnoBody S.r.l., Dalmine, Italy). The Stability Index reflects overall postural control during a multi-axial dynamic balance task on the TecnoBody platform, where lower values indicate better postural stability. This parameter is conceptually comparable to the Overall Stability Index (OSI) reported by the Biodex Balance System, which was used as the reference source for the a priori sample size calculation.

  Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)

Secondary Outcomes (6)

• Change in Mediolateral Standard Deviation of the Center of Pressure (CoP)

  Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)

• Change in Romberg Area Ratio

  Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)

• Change in Limits of Stability (LOS)

  Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)

• Change in Postural Asymmetry Measured by the DIERS Formetric 4D Rasterstereographic Surface Topography System

  Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)

• Change in Unipodal Balance Test Performance

  Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)

Other Outcomes (1)

• Demographic Characteristics of Participants

  Baseline

Study Arms (2)

Individualized Conservative Scoliosis Exercises + HUBER® 360 Feedback Balance Training

EXPERIMENTAL

Participants in this arm receive 40 minutes of clinic-based, physiotherapist-supervised individualized conservative scoliosis exercises followed by 30 minutes of HUBER® 360-based feedback balance training in the clinic. Sessions are delivered three times per week for 4 weeks (12 sessions in total) by a physiotherapist on a one-to-one basis.

Behavioral: HUBER® 360 Balance Training; Behavioral: Individualized Conservative Scoliosis Exercises

Individualized Conservative Scoliosis Exercises + Home-Based Balance Exercise Program

ACTIVE COMPARATOR

Participants in this arm receive 40 minutes of clinic-based, physiotherapist-supervised individualized conservative scoliosis exercises three times per week for 4 weeks (12 clinic sessions in total). In addition, participants perform a 30-minute structured home-based balance exercise program three times per week for the same 4-week period. The home-based balance program is taught in detail by a physiotherapist prior to the intervention period and performed independently by the participant at home.

Behavioral: Home-Based Balance Exercise Program; Behavioral: Individualized Conservative Scoliosis Exercises

Interventions

HUBER® 360 Balance Training BEHAVIORAL

Participants complete 30-minute balance training sessions on the HUBER® 360 Evolution multi-axial neuromuscular training platform (LPG Systems, Valence, France). The platform delivers real-time visual biofeedback on weight distribution and applied force through force sensors in the handles and an integrated screen. The protocol focuses on stretching the posterior chain, opening and increasing the concavity, and reinforcing the convexity. Sessions are supervised by a physiotherapist on a one-to-one basis.

Individualized Conservative Scoliosis Exercises + HUBER® 360 Feedback Balance Training

Home-Based Balance Exercise Program BEHAVIORAL

Participants complete a 30-minute structured home-based balance exercise program three times per week for 4 weeks. The program is taught in detail by a physiotherapist prior to the intervention period and performed independently by the participant at home. It includes bilateral and unilateral stance exercises, balance tasks with eyes open and closed, exercises on different surfaces, and controlled weight-shifting tasks, organized according to a progressive difficulty principle. No device-based or real-time biofeedback is used.

Individualized Conservative Scoliosis Exercises + Home-Based Balance Exercise Program

Individualized Conservative Scoliosis Exercises BEHAVIORAL

Participants perform 40-minute supervised exercise sessions tailored to each patient's curve pattern, apex location, and clinical findings. The program includes posture exercises, pelvic tilt, symmetric extension, scapular adduction with pectoral stretching, asymmetric lateral stretching, Cotrel exercise, flexibility and strengthening exercises, and active three-dimensional postural correction. All sessions are delivered one-to-one by a physiotherapist experienced in scoliosis rehabilitation.

Individualized Conservative Scoliosis Exercises + HUBER® 360 Feedback Balance Training; Individualized Conservative Scoliosis Exercises + Home-Based Balance Exercise Program

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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°

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (3)

• Le Berre M, Guyot MA, Agnani O, Bourdeauducq I, Versyp MC, Donze C, Thevenon A, Catanzariti JF. Clinical balance tests, proprioceptive system and adolescent idiopathic scoliosis. Eur Spine J. 2017 Jun;26(6):1638-1644. doi: 10.1007/s00586-016-4802-z. Epub 2016 Nov 14.

  PMID: 27844226 RESULT

• Shen X, Yang Z, Zhang P, Xu Y, Wang J. Effects of balance training combined with Schroth therapy on adolescents with mild idiopathic scoliosis: A six-week randomized controlled trial. J Back Musculoskelet Rehabil. 2023;36(6):1365-1373. doi: 10.3233/BMR-220383.

  PMID: 37458026 RESULT

• Abdel-Aziem AA, Abdelraouf OR, Ghally SA, Dahlawi HA, Radwan RE. A 10-Week Program of Combined Hippotherapy and Scroth's Exercises Improves Balance and Postural Asymmetries in Adolescence Idiopathic Scoliosis: A Randomized Controlled Study. Children (Basel). 2021 Dec 30;9(1):23. doi: 10.3390/children9010023.

  PMID: 35053648 RESULT

Related Links

• Ankara Etlik City Hospital website
• HUBER® 360 Evolution multi-axial neuromuscular training platform used in the intervention arm of this study - manufacturer website
• DIERS Formetric 4D rasterstereographic surface topography system - manufacturer website

Study Officials

• Ece Ünlü Akyüz, MD, Professor

  Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation

  STUDY CHAIR

• Damla Cankurtaran, MD, Associate Professor

  Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician in Physical Medicine & Rehabilitation

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: April 4, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)