The assessment of the stiffness of the trunk by the Scolibed

Not Applicable

Completed

• Conditions: Scoliosis; Musculoskeletal Diseases

• Registration Number: ISRCTN63196384
• Lead Sponsor: Faculty of Medical Sciences / UMCG, Orthopedics (Faculteit Medische Wetenschappen/UMCG, Orthopedie)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-06
• Study Completion: 2015-06-01
• Last Update Posted: 24 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

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 <20º or >60º
8. Use of strong painkillers or opioids

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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).<br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
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.).