Influence of seat wedges on the scoliosis angle measured by rasterstereography in adolescents aged 10-18 years with adolescent idiopathic scoliosis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00021462

Enrollment

Registered

2021-01-21

Start date

2020-11-18

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M41.1

Interventions

Group 1: 8 rasterstereographic measurements per subject: first measurement while standing, second measurement while seated on a flat seat, measurements 3-8 wedges of different inclination (3°,6°,9°) e

Eligibility

Sex/Gender

All

Age

10 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1: Patients have idiopathic adolescent scoliosis 2: Patients are aged 10-18 years

Exclusion criteria

Exclusion criteria: Patients are excluded from the study if at the time of measurement - have a Cobb angle 50° - numeric rating scale (NRS) >3 - suffer from an acute illness (different from the basic illness scoliosis), such as fever, infections, injuries, nausea - suffer from another chronic disease that affects the balance (e.g. multiple sclerosis) - are under medication that affect vigilance, muscle tone or balance - have back contour changes in the sense of large scars or flat tattoos. - have a BMI =30kg/m2. - have already had surgery on the spine. - the COVID-19 situation is taken into account by the Asklepios Katharina-Schroth-Klinik

Design outcomes

Primary

Measure	Time frame
Primary targets are the changes in the rasterstereographic parameters formetric scoliosis angle and the root mean square (RMS) of the lateral deviation depending on the lateral assignment of the wedges. Null hypothesis: There is no correlation between the side of the scoliosis convexity and the side of the optimal correcting wedge. Statistical evaluation using the Chi-square test. After 30 and 60 patients, an interim evaluation for the primary endpoint is performed using the Haybittle-Peto method.	—

Measure

Time frame

Primary targets are the changes in the rasterstereographic parameters formetric scoliosis angle and the root mean square (RMS) of the lateral deviation depending on the lateral assignment of the wedges. Null hypothesis: There is no correlation between the side of the scoliosis convexity and the side of the optimal correcting wedge. Statistical evaluation using the Chi-square test. After 30 and 60 patients, an interim evaluation for the primary endpoint is performed using the Haybittle-Peto method.

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Secondary

Measure	Time frame
Secondary questions: Are the lateral allocation, degree of inclination and extent of correction of the optimally correcting wedge dependent on the scoliosis type and severity? 2. does a more inclined wedge lead to a stronger correction of the parameters scoliosis angle and lateral deviation RMS? 3. is an improvement in the scoliosis angle and lateral deviation RMS parameters accompanied by a subjectively more comfortable sitting sensation? 4. does the raster stereographic scoliosis angle change when changing from standing to sitting?	—

Measure

Time frame

Secondary questions: Are the lateral allocation, degree of inclination and extent of correction of the optimally correcting wedge dependent on the scoliosis type and severity? 2. does a more inclined wedge lead to a stronger correction of the parameters scoliosis angle and lateral deviation RMS? 3. is an improvement in the scoliosis angle and lateral deviation RMS parameters accompanied by a subjectively more comfortable sitting sensation? 4. does the raster stereographic scoliosis angle change when changing from standing to sitting?

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Countries

Germany

Contacts

Public ContactAndreas Feustel

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

afeustel@students.uni-mainz.de0613117471614

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026