Idiopathic scoliosis (IS): Reduction of scoliosis progression by improving muscle function and muscle strength with vibratio

Phase 4

• Conditions: M41.1; Juvenile idiopathic scoliosis

• Registration Number: DRKS00010657
• Lead Sponsor: Klinik und Poliklinik für Kinder- und JugendmedizinUniversität Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-05-29
• Study Start: 2017-02-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Child/ adolescent with idiopathic scoliosis (AIS), Cobb angle of the main curvature in X-ray 20° to 40 °, date of the last X-ray may no longer than 6 ago, bracet: construction after the Chêneau principle, signed consent of legal guardian and of child/ adolescent if applicable, physiotherapy: at least 1 x/month,after the Schroth concept, wearing the brace min. 16 hrs/ day

Exclusion Criteria

Child / adolescent with idiopathic scoliosis (AIS) with a Cobb angle of the main curvature < 20° to 40 °, gender: male, younger than 10 years, older than 17 years, other forms of scoliosis, general physiotherapy not based on the Schroth concept, Schroth therapy for less than 1 month, wearing the brace for less than 16 hrs/ day, date of last X-ray more than 6 months ago , other neurologic, systemic or osteological diseases, condition after spinal surgery, Hypersplenisyndrom, esophageal varices, acute venous thrombosis, acute inflammation of the locomotor system, acute tendinopathy, acute hernia, migraines, epilepsy, pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessments are performed at baseline (M0) and after six months (M6).<br>Primary outcome: degree of curvature of the spine measured by the Cobb angle.<br>The Cobb angle is measured using upright Standing MRI. The reconstructed coronar image is used for calculating the Cobb angle.

Secondary Outcome Measures

Name	Time	Method
Assessments are performed at baseline (M0) and after six months (M6).<br>1) Muscle function: muscle force and power is measured by mechanography. Mechanography is a medical diagnostic measurement method for motion analysis, assessment of muscle function and muscle power by means of physical parameters (Leonardo Mechanograph®, Novotec Medical GmbH, Pforzheim, Germany)<br>2) Quality of life: assessed by the questionnaire of the Scoliosis Research Society (SRS Questionnaire).