The assessment of the stiffness of the trunk by the Scolibed

• Register: ISRCTN
• Last refreshed on: 24 August 2020
• Main ID: ISRCTN63196384
• Date of registration: 06/05/2015
• Prospective Registration: No
• Primary sponsor: Faculty of Medical Sciences / UMCG, Orthopedics (Faculteit Medische Wetenschappen/UMCG, Orthopedie)
• Public title: The assessment of the stiffness of the trunk by the Scolibed
• Scientific title: The assessment of the stiffness of the trunk by the Scolibed: a pilot study
• Date of first enrolment: 07/04/2015
• Target sample size: 30
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN63196384
• Study type: Interventional
• Study design: Interventional study. First phase directed to determine if the device is reliable and accurate. Second phase is going to be performed to assess the difference in truncal stiffness between healthy subjects and scoliotic patients. (Quality of life)
• Phase: Not Specified

Countries of recruitment

Netherlands

Contacts

• Name: Bart Verkerke

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Scoliosis
Musculoskeletal Diseases

Intervention(s)

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 three straps over the legs). Then the upper part is rotated relative to the lower part.

Primary Outcome(s)

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.

Secondary Outcome(s)

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.).

Secondary ID(s)

N/A

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

Nit provided at time of registration

Results

• Results available: Yes
• Date Completed: 01/06/2015