1. Background
2. Objectives
3. Methods
3.1. Trial Design
3.2. Participants
3.3. Intervention
3.4. Outcomes
3.5. Sample Size
3.6. Randomization
3.7. Blinding
3.8. Statistical Methods
4. Results
| Characteristics | Total | CT Group | ST Group | MT Group | P Value b |
|---|---|---|---|---|---|
| Age (y) | 58.88 ± 8.12 | 59.18 ± 8.95 | 59.63 ± 8.05 | 57.81 ± 8.01 | 0.869 |
| Gender (M: F) | 25: 8 (84.85: 15.15) | 9: 2 (81.82: 18.18) | 8: 3 (72.73: 27.27) | 8: 3 (72.73: 27.27) | 0.860 |
| Disease duration (y) | 7.15 ± 1.48 | 6.91 ± 1.64 | 7.36 ± 1.43 | 7.18 ± 1.47 | 0.780 |
| MMSE | 26.79 ± 2.34 | 27 ± 2.41 | 26.72 ± 2.28 | 26.63 ± 2.54 | 0.935 |
| Disease severity (H&Y) | 1.85 ± 0.57 | 1.82 ± 0.603 | 1.82 ± 0.603 | 1.91 ± 0.54 | 0.915 |
Abbreviations: SD, modified standard deviation; MMSE, mini-mental state exam; H&Y, Hoehn & Yahr scale; CT, combined therapy; ST, speech therapy; MT, music therapy.
aValues are expressed as Mean ± SD or No. (%).
b P < 0.05, ANOVA test.
| CT Group | ST Group | MT Group | F | P Value | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pretest | Posttest | Follow-up | Pretest | Posttest | Follow-up | Pretest | Posttest | Follow-up | Time | Time & Group | Group | Time | Time & Group | Group | |
| DHI functional (n) | 11.27 ± 3.10 | 4.36 ± 1.36 | 4.64 ± 1.75 | 11.91 ± 3.36 | 7.54 ± 2.73 | 7.73 ± 3.35 | 11.54 ± 3.78 | 10.82 ± 3.49 | 11.45 ± 3.88 | 203.56 (1.36,40.70) | 56.53 (2.71,40.70) | 6.18 (2,30) | 0.000 | 0.000 | 0.006 |
| DHI physical (n) | 12.64 ± 3.53 | 5.09 ± 1.45 | 5.18 ± 1.60 | 11.64 ± 3.67 | 7.54 ± 2.73 | 7.91 ± 3.11 | 12.91 ± 4.18 | 12.09 ± 3.91 | 12.64 ± 4.39 | 187.52 (1.11,33.45) | 47.52 (2.23,33.45) | 6.73 (2,30) | 0.000 | 0.000 | 0.004 |
| DHI emotional (n) | 5.27 ± 1.79 | 2.18 ± 1.08 | 2.36 ± 1.36 | 4.91 ± 1.51 | 2.73 ± 1.19 | 2.73 ± 1.42 | 5.82 ± 1.94 | 4.45 ± 1.97 | 4.82 ± 2.36 | 187.34 (1.38,41.45) | 11.79 (2.76,41.45) | 3.92 (2,30) | 0.000 | 0.000 | 0.031 |
| DHI total (n) | 29.18 ± 8.22 | 11.64 ± 3.50 | 11.91 ± 3.91 | 27.45 ± 7.95 | 17.82 ± 5.96 | 18.36 ± 6.33 | 30.36 ± 9.73 | 27.36 ± 9.23 | 28.00 ± 9.77 | 334.08 (1.04,31.35) | 62.73 (2.09,31.35) | 6.34 (2,30) | 0.000 | 0.000 | 0.005 |
| SDQ (n) | 16.27 ± 5.64 | 4.64 ± 1.03 | 4.73 ± 1.27 | 16.00 ± 6.08 | 11.54 ± 3.14 | 12.27 ± 3.47 | 16.36 ± 5.55 | 13.54 ± 5.24 | 13.73 ± 5.46 | 104.49 (1.07,32.12) | 21.11 (2.14,32.12) | 6.27 (2,30) | 0.000 | 0.000 | 0.005 |
Abbreviations: CT, combined therapy; ST, speech therapy; MT, music therapy; dB, decibels; DHI, dysphagia handicap index; SDQ, Swallowing Disturbance Questionnaire.
a P values less than 0.05 were considered statistically significant; repeated-measures ANOVA test. Statistically significant group difference.
b Pretest: Immediately before the intervention; posttest: Immediately after the intervention; follow-up: 3 months after the intervention.
| Pre vs Post | Pre vs Follow-up | Post vs Follow-up | |||||||
|---|---|---|---|---|---|---|---|---|---|
| CT | ST | MT | CT | ST | MT | CT | ST | MT | |
| DHI functional (n) | 0.000 | 0.000 | 0.244 | 0.000 | 0.000 | 1.000 | 0.507 | 1.000 | 0.008 |
| DHI physical (n) | 0.000 | 0.000 | 0.341 | 0.000 | 0.000 | 1.000 | 1.000 | 0.038 | 0.001 |
| DHI emotional (n) | 0.000 | 0.000 | 0.000 | 0.000 | 0.000 | 0.003 | 0.582 | 1.000 | 0.038 |
| DHI total (n) | 0.000 | 0.000 | 0.013 | 0.000 | 0.000 | 0.033 | 0.461 | 0.019 | 0.006 |
| SDQ | 0.000 | 0.001 | 0.034 | 0.000 | 0.003 | 0.042 | 1.000 | 0.009 | 1.000 |
Abbreviations: CT, combined therapy; ST, speech therapy; MT, music therapy; DHI, dysphagia handicap index; SDQ, Swallowing Disturbance Questionnaire.
a P values less than 0.05 were considered statistically significant; repeated-measures ANOVA test.
| CT vs ST | CT vs MT | ST vs MT | ||||
|---|---|---|---|---|---|---|
| Mean Difference | P Value | Mean Difference | P Value | Mean Difference | P Value | |
| DHI functional (n) | -1.97 | 0.410 | -4.51 | 0.004 | -2.54 | 0.172 |
| DHI physical (n) | -1.39 | 0.961 | -4.91 | 0.004 | -3.51 | 0.048 |
| DHI emotional (n) | -0.18 | 1.000 | -1.76 | 0.049 | -1.58 | 0.089 |
| DHI total (n) | -3.64 | 0.771 | -11.00 | 0.004 | -7.36 | 0.078 |
| SDQ | -4.72 | 0.038 | -6.00 | 0.006 | -1.27 | 1.000 |
Abbreviations: CT, combined therapy; ST, speech therapy; MT, music therapy; DHI, dysphagia handicap index; SDQ, Swallowing Disturbance Questionnaire.
a P values less than 0.05 were considered statistically significant; post hoc Bonferroni analysis.
Mean raw data for A, the functional sub-test of the dysphagia handicap index; B, the physical sub-test of the dysphagia handicap index; C, the emotional sub-test of the dysphagia handicap index; D, the total score of the dysphagia handicap index; and E, Swallowing Disturbance Questionnaire. DHI, dysphagia handicap index; SDQ, Swallowing Disturbance Questionnaire. Pretest: 1 week before the first intervention session. Posttest: 1 week after the last intervention session. Follow-up: 3 months after the last evaluation.

