Outcome | Group A (Treatment group) (n = 11) | Group B (Control group) (n = 11) | Group-by-Time Interaction Effect$ | Between-Group Difference in Change, Mean (95% CI)‡ | P Value | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Mean | Change, Mean (95% CI)†| Mean | Change, Mean (95% CI)†| ||||||||
Primary outcome | |||||||||||
Mean rMT (SD), % | Â | Â | Â | Â | Â | ||||||
T0 | 48.55 (5.72) |  | 52.55 (7.15) |  | < 0.001 |  |  | ||||
T1 | 45.18 (5.71) | −3.36 (− 3.94 to − 2.79) | 50.09 (7.71) | −2.45 (− 3.09to − 1.82) |  | −4.91 (− 10.32 to 0.50) | 0.075 | ||||
T2 | 40.36 (5.45) | −8.18 (− 8.93 to − 7.43) | 48.00 (7.43) | −4.55 (− 5.39to − 3.70) |  | −7.64 (− 12.82 to − 2.45) | 0.004 | ||||
Mean pMEPamp (SD), µV |  |  |  |  |  | ||||||
T0 | 499.43 (63.88) |  | 499.98 (105.83) |  | P < 0.001 |  |  | ||||
T1 | 691.33 (152.35) | 191.90 (128.60 to 255.20) | 557.83 (133.84) | 57.85 (35.64to80.07) | Â | 133.5 (19.24 to 247.76) | 0.022 | ||||
T2 | 849.48 (118.79) | 350.05 (285.22 to 414.87) | 597.50 (131.97) | 97.52 (67.79to127.24) |  | 251.9 (151.94to352.03) | < 0.001 | ||||
Mean RC slope (SD) | Â | Â | Â | Â | Â | ||||||
T0 | 0.079 (0.007) |  | 0.079 (0.01) |  | P < 0.001 |  |  | ||||
T1 | 0.12 (0.02) | 0.04 (0.03to0.05) | 0.096 (0.02) | 0.017 (0.012 to 0.02) |  | −0.02 (0.008to0.04) | 0.004 | ||||
T2 | 0.14 (0.02) | 0.06 (0.05 to 0.07) | 0.10 (0.02) | 0.025 (0.02 to 0.03) |  | −0.03 (0.02to0.05) | < 0.001 | ||||
Mean CMCT(SD), ms | Â | Â | Â | Â | Â | ||||||
T0 | 8.35 (1.07) |  | 8.12 (1.75) |  | P < 0.001 |  |  | ||||
T1 | 7.05 (0.95) | −1.30 (− 1.69 to − 0.91) | 7.62 (1.71) | −0.49 (− 0.66 to − 0.32) |  | −0.57 (− 1.67 to 0.53) | 0.308 | ||||
T2 | 5.99 (1.32) | −2.36 (− 3.07 to − 1.66) | 7.02 (1.82) | −1.10 (− 1.46 to − 0.74 |  | −1.03 (− 2.29 to 2.15) | 0.112 | ||||
Secondary outcome | |||||||||||
Mean 6-MWT(SD), m | Â | Â | Â | Â | Â | ||||||
T0 | 101.00 (14.98) | Â | 82.18 (30.95) | Â | 0.012 | Â | Â | ||||
T1 | 119.27 (30.08) | 18.27 (7.68to28.87) | 95.82 (29.16) | 1.64 (0.62to2.65) |  | 23.45 (− 0.15to − 3.98) | 0.051 | ||||
T2 | 153.27 (25.89) | 45.45 (42.18to48.72) | 118.55 (34.10) | 24.36 (17.91to30.81) |  | −21.09 (− 29.35to47.06) | 0.011 | ||||
Mean FMA-LE(SD), (score) | Â | Â | Â | Â | Â | ||||||
T0 | 22.18 (3.37) | Â | 22.91 (2.74) | Â | 0.026 | Â | Â | ||||
T1 | 24.18 (1.78) | 2.00 (0.77to3.23) | 24.18 (1.78) | 1.27 (0.56to1.99) |  | 0.00 (− 1.42to1.42) | 1.000 | ||||
T2 | 27.82 (2.96) | 5.64 (4.34to6.93) | 26.18 (2.09) | 3.27 (1.96to4.58) |  | 1.64 (− 0.41to3.68) | 0.116 | ||||
Grade of FAC(SD), n (%) | Â | Â | Â | Â | 0.026 | ||||||
T0 | 2 | 6 (54.5%) | - | 6 (54.5%) | - | 0.109 | - | Â | |||
3 | 5 (45.5%) | - | 5 (45.5%) | - | |||||||
T1 | 2 | 3 (27.3%) | - | 1 (9.1%) | - | - | - | 0.519 | |||
3 | 7 (63.6%) | - | 9 (81.8%) | - | |||||||
4 | 1 (9.1%) | - | 1 (9.1%) | - | |||||||
T2 | 2 | 2 (18.2%) | - | 0 (0%) | - | - | - | 0.040 | |||
3 | 5 (45.5%) | - | 2 (18.2%) | - | |||||||
4 | 3 (27.3%) | - | 6 (64.5%) | - | |||||||
5 | 1 (9.1%) | - | 3 (27.3%) | - | |||||||
Myoelectricity | Â | Â | Â | Â | Â | ||||||
Mean CR of knee Flexion (SD),% | Â | Â | Â | Â | Â | ||||||
T0 | 43.52 (8.59) | Â | 51.63 (10.57) | Â | 0.491 | Â | Â | ||||
T1 | 27.06 (7.66) | −0.15 (− 0.17to − 0.13) | 37.59(9.16) | −0.15(− 0.17to − 0.13) |  | −0.09(− 0.16to − 0.03) | 0.003 | ||||
T2 | 17.05(5.77) | −0.25(− 0.28to − 0.22) | 27.35(9.66) | −0.25(− 0.28to − 0.23) |  | −0.09(− 0.16to − 0.03) | 0.003 | ||||
Mean CR of ankle dorsiflexion (SD), % | Â | Â | Â | Â | Â | ||||||
T0 | 45.84 (12.25) | Â | 48.06 (14.07) | Â | 0.087 | Â | Â | ||||
T1 | 28.81(8.78) | −0.15(− 0.18to − 0.12) | 35.06(10.02) | −0.15(− 0.18to − 0.12) |  | −0.06(− 0.14to0.14) | 0.115 | ||||
T2 | 15.00(3.40) | −0.27(− 0.31to − 0.23) | 24.71(10.22) | −0.27(− 0.31to − 0.23) |  | −0.06(− 0.14to0.14) | 0.115 | ||||
RMS of Rectus Femoris(SD),µV |  |  |  |  |  |  | |||||
T0 | 57,78(16.67) | Â | 58.20(35.71) | Â | 0.014 | Â | Â | ||||
T1 | 72.71(13.50) | 14.93(7.48to22.38) | 66.16(33.07) | 7.96(3.94to11.98) |  | 6.55(− 13.58to26.68) | 0.524 | ||||
T2 | 91.18(18.68) | 33.40(26.51to40.30) | 78.45(37.86) | 20.25(14.67to18.43) |  | 12.73(− 11.05to36.52) | 0.294 | ||||
RMS of Biceps Femoris (SD), µV |  |  |  |  |  | ||||||
T0 | 36.82(18.50) | Â | 38.32(25.92) | Â | 0.001 | Â | Â | ||||
T1 | 51.16(23.31) | 14.33(6.58to22.09 | 46.80(21.52) | 8.48(4.62to12.34) | Â | 51.15(64.29to22.23) | 0.633 | ||||
T2 | 70.69(18.70) | 33.87(28.77to38.96) | 57.88(25.78) | 19.57(14.20to24.93) | Â | 70.69(81.23to30.76) | 0.162 | ||||
RMS of Tibialis Anterior (SD), µV |  |  |  |  |  | ||||||
T0 | 50.42(21.17) |  | 42.17(27.84) |  | P < 0.001 |  |  | ||||
T1 | 57.60(21.69) | 7.18(− 1.09to15.45) | 56.91(25.27) | 14.74(8.58to20.91) |  | 0.68(− 18.08to19.45) | 0.943 | ||||
T2 | 77.90(22.06) | 27.48(15.45to31.28) | 60.92(29.23) | 18.75(14.49to23.01) |  | 16.98(− 3.65to37.61) | 0.107 | ||||
RMS of Medial Gastrocnemius (SD), µV, |  |  |  |  | |||||||
T0 | 47.64(26.64) | Â | 42.57(19.03) | Â | 0.010 | Â | Â | ||||
T1 | 57.36(21.77) | 9.73(3.86to15.60) | 47.14(22.10) | 4.57(− 0.88to10.02) |  | 10.22(− 7.25to27.70) | 0.252 | ||||
T2 | 76.19(24.82) | 28.55(22.52to34.58) | 59.00(21.47) | 16.43(11.31to21.55) |  | 17.18(− 1.31to35.68) | 0.069 | ||||
Gait | Â | Â | Â | Â | Â | ||||||
Mean cadence (SD), step/min | Â | Â | Â | Â | Â | ||||||
T0 | 34.64(6.48) | Â | 30.99 (6.06) | Â | 0.014 | Â | Â | ||||
T2 | 41.82(7.00) | −7.18 (− 7.81to − 6.55) | 37.04 (6.36) | −6.05 (− 6.70to − 5.39) |  | 4.78 (− 0.55to10.11) | 0.079 | ||||
Mean Gait Cycle Time (SD), S | Â | Â | Â | Â | Â | ||||||
T0 | 1.80(0.38) | Â | 2.04(0.59) | Â | 0.579 | Â | Â | ||||
T2 | 1.48(0.27) | 0.32(0.26to0.38) | 1.68(0.41) | 0.36(0.24to0.46) |  | −0.21 (− 0.48to0.07) | 0.143 | ||||
the ratio of support period to swing period (SD) | Â | Â | 0.006 | Â | Â | ||||||
T0 | 0.48(0.15) | Â | 0.50(0.10) | Â | Â | Â | Â | ||||
T2 | 0.61(0.15) | −0.13 (− 0.15to − 0.11) | 0.59 (0.10) | −0.09 (− 0.11to − 0.08) |  | 0.02 (− 0.08to0.12) | 0.724 |