Table 3.
Results of sensitivity analysis.
| Measurement | ITT Based Primary Analysis (NControl = 24, NURT = 23, NBRT = 24) | PP Based Analysis * (NControl = 23, NURT = 20, NBRT = 24) |
ITT, MI with Chained Equations § (NControl = 24, NURT = 23, NBRT = 24) | |||
|---|---|---|---|---|---|---|
| Estimates of Treatment Effects (95%CI)/OR (95%CI) | p Value | Estimates of Treatment Effects (95%CI)/OR (95%CI) | p Value | Estimates of Treatment Effects (95%CI)/OR (95%CI) | p Value | |
| Primary Outcome | ||||||
| FMA–UE | ||||||
| Control | 6.26 (3.70–8.82) | 0.017 | 6.53 (3.89–9.17) | 0.022 | - | - |
| URT | 7.44 (5.04–9.83) | 7.38 (4.68–10.09) | - | |||
| BRT | 12.88 (9.21–16.54) | 12.90 (9.25–16.56) | - | |||
| Secondary Outcomes | ||||||
| MBI | ||||||
| Control | 8.48 (4.56–12.41) | 0.008 | 8.97 (4.93–13.01) | 0.014 | - | - |
| URT | 10.07 (7.31–12.84) | 10.07 (7.01–13.12) | - | |||
| BRT | 15.68 (12.55–18.80) | 15.68 (12.56–18.79) | - | |||
| RMS_biceps brachii bundle | ||||||
| Control | 36.99 (13.04–60.94) | 0.755 | 40.12 (16.34–63.91) | 0.824 | 36.96 (12.96–60.96) | 0.491 |
| URT | 32.01 (4.26–59.77) | 34.01 (4.97–63.04) | 29.60 (4.08–55.13) | |||
| BRT | 47.01 (18.79–75.23) | 47.00 (18.75–75.26) | 47.01 (18.80–75.22) | |||
| RMS_anterior deltoid bundle | ||||||
| Control | 30.05 (8.25–51.86) | 0.006 | 30.69 (7.92–53.46) | 0.006 | 30.15 (8.36–51.94) | 0.001 |
| URT | 38.33 (15.31–61.35) | 39.60 (15.62–63.58) | 41.53 (20.10–62.97) | |||
| BRT | 117.07 (70.73–163.40) | 116.66 (70.45–162.87) | 117.14 (70.82–163.45) | |||
| RMS_middle deltoid | ||||||
| Control | 47.42 (6.37–88.47) | 0.275 | 50.24 (7.76–92.72) | 0.358 | 47.61 (6.68–88.55) | 0.205 |
| URT | 88.94 (33.81–144.07) | 86.04 (28.50–143.58) | 90.55 (39.38–141.71) | |||
| BRT | 95.23 (49.71–140.75) | 95.04 (49.58–140.50) | 95.44 (49.99–140.90) | |||
| RMS_triceps brachii bundle | ||||||
| Control | 52.42 (18.58–86.26) | 0.635 | 54.89 (20.00–89.77) | 0.505 | 52.31 (18.44–86.19) | 0.493 |
| URT | 36.59 (8.74–64.45) | 33.00 (4.71–61.29) | 35.31 (10.14–60.48) | |||
| BRT | 35.02 (10.98–59.06) | 34.91 (10.83–58.99) | 34.94 (10.91–58.97) | |||
| iEMG_biceps brachii bundle | ||||||
| Control | 28.13 (8.68–47.58) | 0.863 | 30.54 (11.15–49.92) | 0.915 | 28.10 (8.60–47.61) | 0.545 |
| URT | 25.15 (2.57–47.73) | 26.99 (3.39–50.60) | 23.51 (2.83–44.20) | |||
| BRT | 34.56 (9.02–60.09) | 34.56 (8.99–60.12) | 34.55 (9.03–60.07) | |||
| iEMG_anterior deltoid bundle | ||||||
| Control | 21.69 (4.10–39.27) | 0.002 | 22.31 (3.92–40.70) | 0.003 | 21.15 (4.07–38.23) | 0.000 |
| URT | 19.97 (−2.91–42.86) | 20.43 (−3.35–44.21) | 23.43 (1.23–45.63) | |||
| BRT | 91.61 (56.68–126.53) | 91.07 (56.10–126.03) | 91.58 (56.69–126.48) | |||
| iEMG_middle deltoid | ||||||
| Control | 36.79 (−2.98–76.56) | 0.163 | 39.40 (6.43–72.36) | 0.398 | 37.10 (5.37–68.84) | 0.306 |
| URT | 47.34 (22.54–72.13) | 68.77 (25.29–112.25) | 73.46 (35.29–111.63) | |||
| BRT | 87.90 (40.29–135.52) | 69.60 (35.64–103.56) | 69.65 (35.61–103.69) | |||
| iEMG_triceps brachii bundle | ||||||
| Control | 38.06 (6.65–69.48) | 0.901 | 41.60 (18.52–64.69) | 0.499 | 39.62 (17.32–61.92) | 0.636 |
| URT | 29.96 (3.72–56.19) | 26.16 (5.56–46.76) | 28.90 (9.89–47.92) | |||
| BRT | 30.60 (7.39–53.82) | 27.13 (8.79–45.46) | 27.00 (8.83–45.17) | |||
| MEP (response) | ||||||
| Control | Reference | Reference | Reference | |||
| URT | 0.29–15.25 | 0.54 | 1.10 (0.17–7.20) | 0.9 | 1.82 (0.36–10.62) | 0.48 |
| BRT | 0.93–39.81 | 0.08 | 3.67 (0.81–20.50) | 0.1 | 4.00 (0.90–22.21) | 0.08 |
* Per-protocol-based analysis included only patients who completed the study according to the intervention protocol specified at randomization entry; patients who did not receive or complete the study process according to the established protocol were excluded from the analysis. § Based on multiple interpolations using chained equations, assuming missing data at random. The interpolation model included all outcomes and the following predictor variables: sex, age, type of stroke, side of stroke, and length of stroke (week). BRT, bilateral robotic training; CI credit interval; FMA–UE, Fugl-Meyer Assessment-Upper Extremities; iEMG, integrated electromyographic; ITT, intention-to-treat; MBI, Modified Barthel Index; MEP, Motor Evoked Potential; MI, multiple imputations; PP, per protocol; RMS, root mean square; SD, standard deviation; URT, unilateral robotic training.