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Table 2 Primary and secondary outcomes

From: Effects of exoskeleton rehabilitation robot training on neuroplasticity and lower limb motor function in patients with stroke

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), %

     

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)

 

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)

     

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

     

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

     

T0

101.00 (14.98)

 

82.18 (30.95)

 

0.012

  

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)

     

T0

22.18 (3.37)

 

22.91 (2.74)

 

0.026

  

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 (%)

    

0.026

T0

2

6 (54.5%)

-

6 (54.5%)

-

0.109

-

 

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

     

Mean CR of knee Flexion (SD),%

     

T0

43.52 (8.59)

 

51.63 (10.57)

 

0.491

  

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), %

     

T0

45.84 (12.25)

 

48.06 (14.07)

 

0.087

  

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)

 

58.20(35.71)

 

0.014

  

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)

 

38.32(25.92)

 

0.001

  

T1

51.16(23.31)

14.33(6.58to22.09

46.80(21.52)

8.48(4.62to12.34)

 

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)

 

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)

 

42.57(19.03)

 

0.010

  

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

     

Mean cadence (SD), step/min

     

T0

34.64(6.48)

 

30.99 (6.06)

 

0.014

  

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

     

T0

1.80(0.38)

 

2.04(0.59)

 

0.579

  

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)

  

0.006

  

T0

0.48(0.15)

 

0.50(0.10)

    

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

  1. SD: standard deviation; TMS: transcranial magnetic stimulation; BEAR-H1: Bilateral Exoskeletal assistive robot H1; rMT: resting motor threshold; RC slope: Slope of the recruitment curve; pMEPamp: the peak amplitude of motor evoked potential; CMCT: central motor conduction time; FMA-LE: Fugl-Meyer assessment lower extremity; FAC: functional ambulation category; 6-MWT:6-minute walking distance test; sEMG: surface electromyography; RF: rectus femoris; BF: biceps femoris; TA: tibialis anterior; MG: medial gastrocnemius; CR: co-contraction ratio