The assessment of the stiffness of the trunk by the Scolibed

The assessment of the stiffness of the trunk by the Scolibed: a pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN63196384

Enrollment

Registered

2015-05-06

Start date

2015-04-07

Completion date

Unknown

Last updated

2020-08-24

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

Conditions

Scoliosis Musculoskeletal Diseases

Interventions

The subjects are positioned on a vacuum mattress that is fixed to the “Scolibed” and strapped to the bed with Velcro® straps that are passed over the subject’s body (two straps over the upper part and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Control group: 1. Age between 12 and 14 years 2. Individuals able to walk and perform all trunk movements 3. Weight < 120 kg Study group: 1. Idiopathic or congenital scoliosis 2. Age between 12 and 14 years 3. Under treatment at the scoliosis clinic in the UMCG 4. Capability to stand up normally without any supporting devices 5. Cobb angle: between 20° and 60 ° 6. Weight < 120 kg

Exclusion criteria

Exclusion criteria: Control group: 1. Pregnancy 2. Already underwent spinal surgery 3. Recent surgery in trunk or abdomen. Use of implants or prosthesis in trunk or abdomen which limits body motion. 4. Back pain 5. Neurological disorder 6. Any spinal disease 7. Body malformation with effects on body motion 8. History of spinal injury and/or ribcage injury 9. History of handicap 10. Use of strong painkillers or opioids Study group: 1. Pregnancy 2. Already underwent spinal surgery 3. Back pain 4. Neurological disorder 5. Spinal disease not related to scoliosis 6. Body deformation unrelated to scoliosis 7. Scoliosis with Cobb’s Angle 60º 8. Use of strong painkillers or opioids

Design outcomes

Primary

Measure	Time frame
1. Our first goal is to determine the device’s reproducibility. To assess the influence of time variation and operator variation and also to determine the repeatability, each subject must undergo four series of measurements, three in one day (day one) and one after minimum five days and maximum 20 days (day two). 2. After organizing the results a simple analysis regarding the difference among the intra-subject results will be performed using the statistics software SPSS. With the outcome of this analysis, each subject will have a number (referent to the difference found among the results). We will call this number “Variation Coefficient”, shortly “VC”, and like in the table above, we will work with “S1VC”, “S2VC”, and so on. It is determined by calculating the ratio of the standard deviation to the mean value of the intra-subject results. The same statistical method is going to be used to analyse the inter-subject results.	—

Measure

Time frame

1. Our first goal is to determine the device’s reproducibility. To assess the influence of time variation and operator variation and also to determine the repeatability, each subject must undergo four series of measurements, three in one day (day one) and one after minimum five days and maximum 20 days (day two). 2. After organizing the results a simple analysis regarding the difference among the intra-subject results will be performed using the statistics software SPSS. With the outcome of this analysis, each subject will have a number (referent to the difference found among the results). We will call this number “Variation Coefficient”, shortly “VC”, and like in the table above, we will work with “S1VC”, “S2VC”, and so on. It is determined by calculating the ratio of the standard deviation to the mean value of the intra-subject results. The same statistical method is going to be used to analyse the inter-subject results.

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Secondary

Measure	Time frame
Range of truncal stiffness of healthy individuals and scoliotic patients measured by “Scolibed”. We intend to perform statistical analysis of variation to determine if the difference on the stiffness found between our control and study group is statistically significant. After ensuring that the difference found is not “by accident” we want to add some variants (such as gender and severeness of the curve) and compare the results and the likelihood of some statements according to the data collected (e.g. How likely it is that truncal stiffness is larger/ lower in scoliotic patients than in healthy subjects.).	—

Measure

Time frame

Range of truncal stiffness of healthy individuals and scoliotic patients measured by “Scolibed”. We intend to perform statistical analysis of variation to determine if the difference on the stiffness found between our control and study group is statistically significant. After ensuring that the difference found is not “by accident” we want to add some variants (such as gender and severeness of the curve) and compare the results and the likelihood of some statements according to the data collected (e.g. How likely it is that truncal stiffness is larger/ lower in scoliotic patients than in healthy subjects.).

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Countries

Netherlands

Outcome results

None listed

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