Table 3.
Outcome measures of severity following treatment
| Outcome | Baseline (Mean ± SD) |
Week 6 (Mean ± SD) |
Week 12 (Mean ± SD) |
Change from baseline | |
|---|---|---|---|---|---|
| Week 6 | Week 12 | ||||
| Patient measures | |||||
| Quality of Life (OMDQ-25) | 47.39 ± 23.00 | 43.22 ± 23.24 | 38.00 ± 21.42 | − 4.17 (p = 0.19) |
− 9.39 (p = 0.04) |
| Speech (BFM-q21) | 1.33 ± 0.91 | 0.94 ± 0.87 | 0.94 ± 0.75 | − 0.39 (p = 0.049) |
− 0.39 (p = 0.03) |
| Drooling (SCS-PD) | 3.00 ± 3.91 | 2.72 ± 4.28 | 2.53 ± 3.20 | − 0.28 (p = 0.75) |
− 0.47 (p = 0.55) |
| Ease of chewing and swallowing (SDQ-20) | 13.17 ± 9.54 | 15.61 ± 8.56 | 13.29 ± 8.54 | 2.44 (p = 0.18) |
0.12 (p = 0.72) |
| Unblinded investigator face to face measures | |||||
| Unblinded UDRS jaw/tongue | 4.67 ± 1.15 | 3.47 ± 1.58 | 3.26 ± 1.47 | − 1.2 (p < 0.001) |
− 1.41 (p < 0.001) |
| Unblinded GDS jaw/tongue | 5.67 ± 1.53 | 3.94 ± 2.10 | 3.76 ± 2.25 | − 1.73 (p < 0.001) |
− 1.91 (p = 0.001) |
| CGI-severity | 4.06 ± 1.00 | 3.22 ± 1.11 | 3.29 ± 0.92 | − 0.84 (p = 0.002) |
− 0.77 (p = 0.004) |
| CGI-improvement | n/a | 2.89 ± 1.28 | 2.53 ± 0.87 | n/a | n/a |
| CGI-efficacy | n/a | 1.51 ± 0.93 | 1.93 ± 0.97 | n/a | n/a |
| Blinded rater video assessment measures | |||||
| GDS jaw/tongue | 3.80 ± 2.29 | 3.57 ± 2.05 | 3.71 ± 2.18 | − 0.23 (p = 0.61) | − 0.09 (p = 0.84) |
| UDRS jaw/tongue | 3.50 ± 1.92 | 3.47 ± 1.79 | 3.30 ± 1.72 | − 0.03 (p = 0.92) | − 0.30 (p = 0.58) |