Table 2.
Pre-post differences in clinical profile and gait characteristics for active nVNS and sham nVNS groups.
| Clinical outcome variables | Baseline (Pre for nVNS) Mean (SD) | Post-intervention nVNS Mean (SD) | P value pre-post nVNS | Baseline (Pre for sham) Mean (SD) | Post-intervention sham Mean (SD) | P value pre-post sham |
|---|---|---|---|---|---|---|
| Gait outcome variables | ||||||
| Velocity | 61.9 ± 20.3 | 72 ± 19.1 | 0.003* | 66.6 ± 20.3 | 68.31 ± 18.2 | 0.689 |
| Step length | 36.2 ± 10.3 | 40.3 ± 10.15 | 0.007* | 36.8 ± 10.4 | 37.2 ± 10 | 0.797 |
| Swing time variability | 0.04 ± 0.02 | 0.03 ± 0.02 | 0.085 | 0.04 ± 0.03 | 0.04 ± 0.03 | 0.432 |
| Step time | 0.6 ± 0.10 | 0.57 ± 0.08 | 0.003* | 0.57 ± 0.099 | 0.55 ± 0.08 | 0.059 |
| Swing time | 0.37 ± 0.06 | 0.38 ± 0.07 | 0.970 | 0.36 ± 0.07 | 0.35 ± 0.07 | 0.338 |
| Stance time | 0.83 ± 0.17 | 0.75 ± 0.12 | 0.001* | 0.77 ± 0.16 | 0.74 ± 0.12 | 0.304 |
| Stride velocity variability | 6.4 ± 3.2 | 6.9 ± 3.4 | 0.846 | 6.9 ± 2.55 | 6.9 ± 2.43 | 0.841 |
| Step length variability | 3.9 ± 1.5 | 4.0 ± 2.3 | 0.440 | 4.1 ± 1.2 | 4.3 ± 1.3 | 0.543 |
| Step time variability | 0.05 ± 0.03 | 0.04 ± 0.02 | 0.114 | 0.05 ± 0.03 | 0.05 ± 0.035 | 0.920 |
| Step time asymmetry | 0.04 ± 0.04 | 0.02 ± 0.02 | 0.056 | 0.03 ± 0.03 | 0.03 ± 0.04 | 0.819 |
| Step length asymmetry | 3.1 ± 2.4 | 2.5 ± 2.2 | 0.149 | 2.7 ± 2.4 | 2.7 ± 2.1 | 0.808 |
| Step width | 11 ± 2.9 | 10.7 ± 2.9 | 0.357 | 10.8 ± 2 | 10.7 ± 3.7 | 0.424 |
| Clinical characteristics | ||||||
| MDS-UPDRS I | 16 ± 7 | 13 ± 8 | 0.004* | 16 ± 7 | 13 ± 8 | 0.030 |
| MDS-UPDRS II | 21 ± 6 | 17 ± 7 | 0.001* | 22 ± 5 | 18 ± 5 | 0.009* |
| MDS-UPDRS III | 40 ± 1 | 33 ± 1 | 0.002* | 39 ± 10 | 32 ± 12 | 0.002* |
| H & Y | 2 ± 0.5 | 2 ± 0.5 | 0.083 | 2 ± 0.7 | 2 ± 0.7 | 0.655 |
| TUG (s) | 39 ± 77 | 42 ± 101 | 0.033 | 45 ± 67 | 35 ± 47 | 0.098 |
| FES | 54 ± 13 | 48 ± 13 | 0.001* | 56 ± 7 | 50 ± 8 | 0.003* |
| MMSE | 26 ± 4 | 25 ± 6 | 0.195 | 26 ± 4 | 27 ± 3 | 0.905 |
| RBDSQ | 5.2 ± 2.9 | 4.1 ± 3 | 0.036 | 4 ± 2.8 | 3.6 ± 2.9 | 0.177 |
| Total FOG-Q score | 16.5 ± 3.5 | 13.2 ± 3.9 | 0.001* | 15.5 ± 3 | 11.9 ± 4.3 | 0.001* |
| DRS Total | 124.8 ± 14.8 | 120.6 ± 28.9 | 0.727 | 120 ± 18.4 | 114 ± 31.6 | 0.819 |
The differences were assessed by Wilcoxon Sign Rank Test; P < 0.05 (*) was considered significant after correction for multiple comparisons. [SD = Standard Deviation; MDS-UPDRS = MDS-Unified Parkinson’s disease Rating Scale; H&Y = Hoehn and Yahr scale; TUG = Timed Up and Go test; FES = Falls Efficacy Scale; MMSE = Mini Mental State Examination; RBDSQ = REM Sleep Behaviour Disorder Screening Questionnaire; FOG-Q = Freezing of Gait Questionnaire].