NCT07285551

Brief Summary

The aim of this study is to assess how physiotherapy based on the Rigo Concept, combined with WBV, affects sagittal spinal curvatures, the angle of trunk rotation (ATR), and trunk symmetry in girls with AIS. Participants undergo a 5-day individualized physiotherapy program. The exercises follow the four general principles of the Rigo Concept: three-dimensional postural correction, expansion technique, muscle activation, and integration. Therapy is delivered for 3 hours per day, with three 15-minute breaks. Additionally, participants in the Rigo Concept with WBV group perform exercises in a standing position using two poles while exposed to WBV on a Galileo Med 35 platform (Novotec Medical GmbH, Pforzheim, Germany) at a frequency of 25 Hz, with a peak-to-peak displacement of 2 mm. Each session includes three 3-minute bouts of vibration, with 3-minute rests between them. During WBV, participants perform exercises according to the principles of the Rigo Concept.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
Last Updated

March 5, 2026

Status Verified

December 1, 2025

Enrollment Period

5 days

First QC Date

November 17, 2025

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Measurements of the sagittal curvature of the spine

    The examination of spinal curvatures (degrees) in the sagittal plane is conducted using a Baseline digital inclinometer (MVS in Motion, Belgium). Measurements are taken in a relaxed standing position. The assessment includes evaluation of thoracic kyphosis (upper and lower parts), lumbar lordosis, and sacral slope. The procedure is as follows: 1) Thoracic kyphosis - the inclinometer is zeroed at the thoracolumbar junction (Th12-L1), and the value is recorded at the cervicothoracic junction (C7-Th1); 2) Lumbar lordosis - the inclinometer is zeroed at the lumbosacral junction (L5-S1), and the value is recorded at the thoracolumbar junction (Th12-L1); 3) Sacral slope - the inclinometer is zeroed in the horizontal position, and the value is recorded at the lumbosacral junction (L5-S1).

    Before the first physiotherapy session and three hours after the last physiotherapy session

  • Measurements of the trunk symmetry

    For postural alignment (centimeters), the physician positions a plumb line at the level of the occipital prominence. Measurements are performed using a rigid millimeter ruler and are rounded to the nearest 0 or 5 mm, assessing the distance from the plumb line to the gluteal cleft. For the assessment of scapular height asymmetry, the inferior angles of the scapulae are marked bilaterally. A rigid ruler is placed across these points, and a scoliometer is positioned on the ruler to record the angle of inclination (degrees). The distances from the inferior angles of the scapulae to the line of spinous processes are measured on both the left and right sides using a rigid ruler, and the differences (centimeters) are then calculated.

    Before the first physiotherapy session and three hours after the last physiotherapy session

  • Measurements of the angle of trunk rotation

    The measurements of the angle of trunk rotation in the transverse plane are conducted using a Baseline scoliometer (MoVeS, Poland). The angle of trunk rotation is assessed during the Adams forward bend test. The participant stands in a relaxed upright position and is instructed to keep their hands together and slowly bend forward, aiming their hands toward the center of support. The examiner records the angle (degrees) and direction (left/right) of trunk rotation at the proximal and main thoracic spine, thoracolumbar region, lumbar spine, and at the level of the posterior superior iliac spine.

    Before the first physiotherapy session and three hours after the last physiotherapy session

Study Arms (2)

Rigo Concept group

ACTIVE COMPARATOR

Physiotherapy/exercieses according to the Rigo Concept, 5 days, 3 hour per day

Procedure: Rigo Concept group

Rigo Concept with whole-body vibration group

EXPERIMENTAL

Physiotherapy/exercises according to the Rigo Concept combined with whole-body vibration, 5 days, 3 hour per day, supplemented with 3 x 3 minutes of WBV, frequency 25 Hz, amplitude 2 mm

Procedure: Rigo Concept with whole-body vibration group

Interventions

5-day physiotherapy based on the Rigo Concept. It has four general principles of correction such as three-dimensional stable postural correction, expansion technique, muscle activation, and integration. Intervention last for 3 hours per day.

Rigo Concept group

The same like in the Rigo Concept groupa and additionally in standing position with two poles from Rigo Concept they will be exposed to WBV on a Galileo Med25 platform. WBV will administer in 3 x 3-minute sessions per day at a frequency of 25 Hz and an amplitude of 2 mm.

Rigo Concept with whole-body vibration group

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinical diagnosis of the adolescent idiopathic scoliosis
  • Written consent of a medical doctor for participation
  • Female

You may not qualify if:

  • thrombosis
  • body implants
  • musculoskeletal inflammation
  • arthropathy
  • tendonitis
  • hernia
  • disc herniation
  • recent fractures
  • kidney stones
  • recent scars
  • surgery
  • rheumatoid arthritis
  • neuropathy
  • epilepsy
  • previous spinal surgery
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korrektiv

Gdansk, Poland

Location

Study Officials

  • Paulina Ewertowska

    Gdansk University of Physical Education and Sport

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

December 16, 2025

Study Start

February 15, 2026

Primary Completion

February 20, 2026

Study Completion

February 25, 2026

Last Updated

March 5, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations