Table 2.
Treatment effects at immediately postintervention and 12-week follow-up in the intention-to-treat population
| CIAT Plus | M-MAT | Usual care | CIAT Plus versus usual care | M-MAT versus usual care | M-MAT versus CIAT Plus | ||||
| Unadjusted mean change score PIV-Baseline (SD) | Unadjusted mean change score PIV-Baseline (SD) | Unadjusted mean change score PIV-Baseline (SD) | Adjusted mean difference (95% CI) | P value | Adjusted mean difference (95% CI) | P value | Adjusted mean difference (95% CI) | P value | |
| Primary outcome | |||||||||
| Aphasia severity, WAB-R-AQ | 0.96 (4.81) | 1.04 (5.17) | 2.06 (6.56) | −1.05 (−2.88 to 0.78) | 0.36 | −1.06 (−2.89 to 0.78) | 0.36 | −0.004 (−1.77 to 1.76) | 1.00 |
| Key secondary outcomes at post-intervention | |||||||||
| Aphasia severity, WAB-R-AQ by severity stratum | |||||||||
| Mild | 0.51 (4.56) | 1.43 (3.57) | 1.11 (5.25) | + | + | 0.93 (−0.71 to 2.56) | 0.26 | ||
| Moderate | 2.35 (5.60) | −1.33 (6.54) | 4.74 (9.00) | + | + | −3.71 (−6.36 to 1.06) | 0.006* | ||
| Severe | 0.40 (3.68) | 8.35 (7.05) | NA (n=0) | + | + | 7.83 (0.87 to 14.80) | 0.03* | ||
| Functional communication, CETI | 2.96 (11.85) | 4.29 (10.47) | −1.83 (10.15) | 4.32 (0.03 to 8.61) | 0.048* | 4.64 (0.32 to 8.95) | 0.032* | 0.31 (−3.81 to 4.44) | 0.98 |
| Multimodal communication, Scenario Test | −0.30 (4.62) | 1.83 (5.78) | 1.20 (4.39) | −1.57 (−3.29 to 0.15) | 0.08 | 0.31 (−1.40 to 2.02) | 0.90 | 1.88 (0.195 to 3.57) | 0.0245* |
| Overall quality of life, SAQOL-39g: Mean Score | 0.06 (0.35) | 0.17 (0.38) | −.02 (0.37) | 0.09 (−0.03 to 0.21) | 0.17 | 0.20 (0.08 to 0.31) | 0.0004* | 0.10 (−0.01 to 0.22) | 0.085 |
| Communication-related quality of life, SAQOL-39g: Communication Scale | 0.15 (0.64) | 0.41 (0.49) | −.03 (0.57) | 0.20 (0.01 to 0.39) | 0.039* | 0.43 (0.24 to 0.62) | <0.0001* | 0.24 (0.05 to 0.42) | 0.008* |
| COMPARE naming battery: 80 treated items | 15.61 (11.38) | 11.30 (10.95) | 3.90 (7.73) | 10.73 (7.83 to 13.63) | <0.0001* | 7.49 (4.58 to 10.41) | <0.0001* | −3.24 (−6.05 to 0.43) | 0.019* |
| COMPARE naming battery: 100 untreated items | 4.09 (9.86) | 2.32 (8.95) | 0.51 (10.09) | 3.64 (0.79 to 6.50) | 0.0081* | 1.71 (−1.16 to 4.58) | 0.3402 | −1.93 (−4.71 to 0.84) | 0.2281 |
| Key secondary outcomes at 12 week follow-up | |||||||||
| Aphasia severity, WAB-R-AQ | 0.65 (5.85) | 2.0 (5.02) | 3.07 (6.58) | −2.39 (−4.24 to 0.53) | 0.008* | −1.15 (−3.01 to 0.71) | 0.32 | 1.24 (−0.56 to 3.04) | 0.24 |
| Aphasia severity, WAB-R-AQ by severity stratum | |||||||||
| Mild | 0.37 (5.52) | 2.38 (3.89) | 1.78 (5.84) | + | + | 2.03 (0.38 to 3.67) | 0.02* | ||
| Moderate | 1.40 (7.03) | 0.74 (7.56) | 6.54 (7.39) | + | + | −0.64 (−3.42 to 2.13) | 0.65 | ||
| Severe | 2.60 (NA; n=1) | 3.00 (3.08) | NA (n=0) | + | + | 1.33 (−7.37 to 10.03) | 0.76 | ||
| Functional communication, CETI | 2.64 (15.05) | 3.83 (16.58) | 0.20 (13.31) | 2.14 (−2.31 to 6.59) | 0.49 | 2.68 (−1.77 to 7.13) | 0.33 | 0.54 (−3.73, 4.81) | 0.95 |
| Multimodal communication, Scenario Test | 0.57 (6.10) | 1.76 (5.90) | 1.45 (6.17) | −0.91 (−2.67 to 0.85) | 0.45 | 0.30 (−1.43 to 2.03) | 0.91 | 1.21 (−0.5 to 2.92) | 0.22 |
| Overall quality of life, SAQOL-39g: Mean Score | −0.02 (0.38) | 0.08 (0.35) | 0.01 (0.36) | −0.03 (−0.15 to 0.10) | 0.87 | 0.07 (−0.05 to 0.19) | 0.38 | 0.09 (−0.25 to 0.211) | 0.15 |
| Communication-related quality of life, SAQOL-39g: Communication Scale | 0.11 (0.60) | 0.17 (0.64) | 0.11 (0.67) | −0.001 (−0.194 to 0.193) | 0.9999 | 0.036 (−0.157 to 0.229) | 0.898 | 0.037 (−0.151 to 0.225) | 0.887 |
| COMPARE naming battery: 80 treated items | 9.35 (7.76) | 8.61 (8.55) | 4.00 (7.80) | 4.23 (1.30 to 7.16) | 0.002* | 4.42 (1.49 to 7.35) | 0.001* | 0.186 (−2.67 to 3.04) | 0.987 |
| COMPARE naming battery: 100 untreated items | 3.24 (8.24) | 3.46 (9.52) | 2.97 (6.76) | 0.06 (-2.83 to 2.96) | 0.9985 | 0.26 (-2.64 to 3.16) | 0.9753 | 0.20 9 (2.63 to 3.02) | 0.953 |
NB: Bold and *: Statistically significant difference; +These comparisons were not planned for in our statistical analysis plan.23
CETI, Communication Effectiveness Index; CIAT-Plus, Constraint-Induced Aphasia Therapy; COMPARE, Constraint-Induced or Multi-Modality Personalised Aphasia Rehabilitation; M-MAT, Multimodality Aphasia Therapy; N/A, not available; PIV, Post-intervention; SAQOL-39g, Stroke and Aphasia Quality of Life Scale-39g; WAB-R-AQ, Western Aphasia Battery-Revised Aphasia Quotient.