Development and first application of a standardized assessment to measure posture correction ability in terms of symmetry in patients with adolescent idiopathic scoliosis using video rasterstereography

Not Applicable

• Conditions: M41.1; Juvenile idiopathic scoliosis

• Registration Number: DRKS00021465
• Lead Sponsor: niversitätsmedizin der Johannes Gutenberg-Universität Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

The research project will include subjects who have been previously diagnosed with adolescent idiopathic scoliosis and are expected to spend at least three weeks as inpatients at the AKSK Bad Sobernheim. Gender or ethnicity is not a factor. The age of the participants should be between 10 and 18 years.

Exclusion Criteria

Since the study is exclusively for subjects with AIS, the following spinal deformities are excluded:

- Neuromuscular scolioses
- Congenital scolioses
- Infantile and juvenile scoliosis
- Secondary scolioses.

Since it is important in the context of the study to implement instructions for adopting a specific posture, subjects with the following characteristics will also be excluded:

- Patients with mental retardation
- Patients with surgical fusion of the spine
- Patients with indication of pain at rest above a value of 3 on the visual analogue scale from 0 (no pain) to 10 (strongest imaginable pain)
- Patients with an acute medical condition, such as fever, unhealed injuries, dizziness, nausea or balance problems
- Patients with chronic diseases that have an effect on movement behavior or the sense of balance
- Patients taking medications that affect vigilance, muscle tone or the central nervous system
- Patients with back contour changes due to large scars, a BMI = 30kg/m² or tattoos on the back
- Pregnant patients
- Patients who are not fully capable of consent or understanding

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is the reduction in spinal deviation from the symmetry line as measured by the Formetric device. The deviation of a patient's spine is determined by the system as the Root Mean Square (RMS) of the position of the vertebral bodies relative to the symmetry line. The reduction or difference in RMS is the measured value in standardized posture minus the measured value in habitual posture.<br><br>For the primary endpoint, it will be tested whether there is a significant improvement in the patient's symmetry as a result of adopting the standardized posture, i.e., whether the difference in RMS values is significantly less than zero. To test this hypothesis, a one-sided t-test will be performed for the mean of the RMS differences.

Secondary Outcome Measures

Name	Time	Method
1. Change of symmetry in habitual posture (comparison of measurements in habitual posture from measurement date 1 and 2) <br><br>2. Change of symmetry in standardized corrective posture (comparison of measurements in standardized corrective posture from measurement dates 1 and 2)<br><br>3. Change in posture correction ability (comparison of the difference between habitual posture and standardized corrective posture from measurement dates 1 and 2).