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18 patients underwent more specialized clinical neurological assessment, using the Total Neuropathy Scale-clinical version (TNSc) [ 14] and encompassing symptoms, pinprick and vibration sensibility, strength and deep tendon reflexes (total score 0 28).
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The two project coordinators calculated the total score and the centile rank for each assessment using the centile graph on the AIMS score-sheet (Fig. 1).
Outcome assessment was performed using the total ICU expenses in the period divided by the sum of the life expectancy (years) in survivors after 18 months.
Efficacy assessments encompassed clinical assessment, assessment of CD using the TWSTRS total score (recorded at all visits) 11, assessment of tremor using the Tsui Tremor subscale (recorded at all visits) 12, assessment of Clinical Global Improvement CGII) by both investigator and subject (recorded at visit 2) and CD Impact Profile-58 (CDIP-58) (recorded at visits 1 and 2).
The clinical data included an injury assessment using total body CT scan, Injury Severity Score (ISS), Abbreviated Injury Score (AIS), ICU and hospital length of stay and outcome score.
The 3D as-built model was then subjected to an accuracy assessment using reference points acquired by a total station.
Assessment of CD symptom severity using the Tsui total score was repeated at weeks 4 and 12 post-treatment.
A skin thickening assessment was evaluated using the modified Rodnan total skin score and disease activity was assessed with the SDAI [ 44, 45].
An alternative method based on the assessment of total protein using the Pierce Coomassie Plus (Bradford) Assay was also evaluated and compared.
HbA1c measurement was based on the assessment of total Hb using the colorimetric method, the A1c concentration was determined by means of the turbidimetric immuno-inhibition method (Synchrone DXC 800 1, Beckmann Coulter, USA) with a inter-assay CV of 2.9 3.2%.
A total of 312 mobility assessments were performed using the 17 mobility items.
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