CompletedNot Applicable

Effectiveness of a Novel Scoliosis Therapy Using a Standing Scoliosis Therapy Device With Biological Feedback Mechanism

Poland32 participantsStarted 2021-07-05

Plain-language summary

This study evaluates the effectiveness of a novel standing scoliosis therapy device with a biofeedback mechanism in children and adolescents with adolescent idiopathic scoliosis (AIS). Participants are assigned to one of three groups: SkolioMaster (prototype device), Skol-As therapy, or the FITS method. The primary objective is to assess whether the device reduces spinal curvature (Cobb angle). Secondary objectives include evaluating its effects on other physical outcomes. Participants will attend rehabilitation sessions twice weekly for six months and undergo clinical and radiographic assessments.

Who can participate

Age range

8 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children and adolescents aged 8 to 16 years * Diagnosis of adolescent idiopathic scoliosis (AIS) * Cobb angle between 10° and 50° confirmed on standing spinal radiograph * Skeletal immaturity defined as Risser sign 0-3 * Ability to participate in physiotherapy sessions * Written informed consent provided by parent or legal guardian (and assent from the participant when applicable) Exclusion Criteria: * Scoliosis of known etiology (e.g., neuromuscular, congenital, syndromic, or metabolic) * Functional scoliosis * Age below 8 years or above 16 years * Lack of consent from participant and/or legal guardian * Inability to comply with the study protocol or attend regular therapy sessions * Medical conditions preventing safe participation in rehabilitation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Cobb angle of the primary spinal curvature

Timeframe: Baseline and 24 weeks

Trial details

NCT IDNCT07585110

SponsorCentrum Medyczne Katarzyna Smółka

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-17

View on ClinicalTrials.gov More Idiopathic Scoliosis trials