Sixty-two patients with severe OA underwent TKR surgery in this clinical trial. This study randomized patients into two groups: the control group, which used the standard TKR rehabilitation protocol, as shown in Table 1, and the experimental group, which used gait training with the Co-walk in addition to 15 minutes of the usual 45-minute rehabilitation protocol. The cohort included 11 males (17.74%) and 51 females (82.26%). The participants' average age was 67.77 years old, the average height was 154.61 cm, and the average BMI was 26.44 kg/m2. The analysis of demographic characteristics revealed no significant difference between the two groups of patients, as shown in Table 2.
Knee
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|
|
|
|
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(n = 62)
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(n = 31)
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(n = 31)
|
|
Characteristic
|
total
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Co-walk
|
Non Co-walk
|
p
|
Table 2
Left
|
28(45.16)
|
11(35.48)
|
17(54.84)
|
0.126
|
Right
|
34(54.84)
|
20(64.52)
|
14(45.16)
|
|
Sex
|
|
|
|
|
Male
|
11(17.74)
|
8(25.81)
|
3(9.68)
|
0.096
|
Female
|
51(82.26)
|
23(74.19)
|
28(90.32)
|
|
Age(years)
|
67.77 ± 7.01
|
68.06 ± 7.16
|
67.48 ± 6.96
|
0.747
|
Weight(kgs.)
|
63.18 ± 11.61
|
63.55 ± 11.39
|
62.82 ± 11.99
|
0.805
|
Height(cms.)
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154.61 ± 7.74
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155.19 ± 7.78
|
154.03 ± 7.80
|
0.559
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BMI
|
26.44 ± 4.53
|
26.37 ± 4.10
|
26.52 ± 5.00
|
0.894
|
Length of stay(days)
|
6.08 ± 2.14
|
5.84 ± 1.66
|
6.32 ± 2.55
|
0.379
|
The range of Motion (ROM) Mean ± S.D.
|
89.68 ± 17.06
|
89.68 ± 12.45
|
89.68 ± 20.89
|
1.00
|
WOMAC
Pain (Mean ± S.D.)
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30.05 ± 10.10
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29.23 ± 10.58
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30.87 ± 9.71
|
0.526
|
WOMAC
Movement (Mean ± S.D.)
|
94.66 ± 24.87
|
94.87 ± 23.04
|
94.45 ± 26.96
|
0.948
|
WOMAC
Stiff (Mean ± S.D.)
|
12.44 ± 4.42
|
12.32 ± 3.70
|
12.55 ± 5.10
|
0.843
|
Length of stay(days)
|
6.08 ± 2.14
|
5.84 ± 1.66
|
6.32 ± 2.55
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0.379
|
The results of the clinical trial established a normal distribution of the balance score data in both groups. No patients in either group experienced an injury during the rehabilitation process, and no surgery failed in either group, as shown in Table 3.
ROM
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(n = 62)
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(n = 31)
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(n = 31)
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total
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Co-walk
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P*
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Non Co-walk
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P*
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P**
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Table 3
ROM, Weight left or right between Co-Walk and Non Co-walk.
Before surgery
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89.68 ± 17.06
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89.68 ± 12.45
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< 0.001
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89.68 ± 20.89
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< 0.001
|
1.00
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1–2 day after surgery
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88.87 ± 13.26
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90.65 ± 13.77
|
|
87.10 ± 12.70
|
|
0.296
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2wk after surgery
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100.48 ± 15.25
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103.39 ± 12.61
|
|
97.58 ± 17.22
|
|
0.135
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6wk after surgery
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111.26 ± 13.86
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113.00 ± 11.58
|
|
109.52 ± 15.83
|
|
0.327
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3mo after surgery
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116.13 ± 13.01
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119.84 ± 8.99
|
|
112.42 ± 15.32
|
|
0.024
|
6mo after surgery
|
122.79 ± 10.09
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124.29 ± 8.10
|
|
121.29 ± 11.69
|
|
0.245
|
Average day 1- 6mo
|
104.87 ± 10.98
|
106.81 ± 8.98
|
|
102.93 ± 12.51
|
|
0.167
|
TUG
|
|
|
|
|
|
|
1–2 day after surgery
|
69.93 ± 17.34
|
71.82 ± 16.65
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< 0.001
|
68.03 ± 18.07
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< 0.001
|
0.394
|
2wk after surgery
|
30.01 ± 16.87
|
18.10 ± 6.45
|
|
41.92 ± 15.62
|
|
< 0.001
|
6wk after surgery
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18.09 ± 10.41
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13.23 ± 3.32
|
|
22.94 ± 12.67
|
|
< 0.001
|
3mo after surgery
|
14.08 ± 7.05
|
11.69 ± 2.52
|
|
16.47 ± 9.10
|
|
0.008
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6mo after surgery
|
11.90 ± 4.69
|
11.04 ± 1.87
|
|
12.76 ± 6.29
|
|
0.153
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Average day 1- 6mo
|
28.80 ± 8.33
|
25.18 ± 3.81
|
|
32.43 ± 9.98
|
|
0.769
|
Weight Left
|
|
|
|
|
|
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1–2 day after surgery
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50.19 ± 13.37
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51.26 ± 10.26
|
0.603
|
49.13 ± 15.99
|
0.777
|
0.535
|
2wk after surgery
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49.44 ± 9.55
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49.55 ± 8.59
|
|
49.32 ± 10.56
|
|
0.927
|
6wk after surgery
|
49.89 ± 5.71
|
50.03 ± 4.90
|
|
49.74 ± 6.51
|
|
0.843
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3mo after surgery
|
49.95 ± 4.25
|
49.94 ± 3.10
|
|
49.97 ± 5.21
|
|
0.976
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6mo after surgery
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49.84 ± 2.65
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49.74 ± 2.16
|
|
49.94 ± 3.10
|
|
0.776
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Average day 1- 6mo
|
49.86 ± 6.39
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50.10 ± 4.57
|
|
49.62 ± 7.88
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|
0.769
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Weight Right
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|
|
|
|
|
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1–2 day after surgery
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49.81 ± 13.34
|
48.74 ± 10.20
|
0.586
|
50.87 ± 15.99
|
0.777
|
0.535
|
2wk after surgery
|
50.61 ± 9.59
|
50.55 ± 8.69
|
|
50.68 ± 10.56
|
|
0.958
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6wk after surgery
|
50.10 ± 5.72
|
49.94 ± 4.91
|
|
50.26 ± 6.51
|
|
0.827
|
3mo after surgery
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50.08 ± 4.27
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50.13 ± 3.14
|
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50.03 ± 5.21
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|
0.930
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6mo after surgery
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50.15 ± 2.64
|
50.23 ± 2.14
|
|
50.06 ± 3.10
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|
0.812
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Average day 1- 6mo
|
50.15 ± 6.40
|
49.92 ± 4.58
|
|
50.38 ± 7.88
|
|
0.778
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Diff Weight Left to Right
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|
|
|
|
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1–2 day after surgery
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-0.39 ± 26.71
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-2.52 ± 20.45
|
0.594
|
1.74 ± 31.98
|
0.777
|
0.535
|
2wk after surgery
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1.18 ± 19.12
|
1.00 ± 17.26
|
|
1.35 ± 21.11
|
|
0.942
|
6wk after surgery
|
0.21 ± 11.44
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-0.10 ± 9.81
|
|
0.52 ± 13.02
|
|
0.835
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3mo after surgery
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0.13 ± 8.52
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0.19 ± 6.23
|
|
0.06 ± 10.42
|
|
0.953
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6mo after surgery
|
0.31 ± 5.29
|
0.48 ± 4.30
|
|
0.13 ± 6.20
|
|
0.794
|
Average day 1- 6mo
|
0.29 ± 12.79
|
-0.19 ± 9.15
|
|
0.76 ± 15.76
|
|
0.773
|
* p-value within group related mean before surgery to 6 months after surgery by repeated measure ANOVA .
** p-value for comparison of mean between group by Independent t test.
The control group (Non-Co-Walk) and the experimental group (Co-Walk) of TKR patients were compared in terms of preoperative and postoperative ROM. The ROM of the experimental group (119.84 ± 8.99) was significantly different from that of the control group (112.42 ± 15.32) (p = 0.024) at 6 weeks, as shown in Fig. 3.
The TUG scores of the experimental group (18.10 ± 6.45) and those of the control group (41.92 ± 15.62) were significantly different (p < 0.001) at 2 weeks, 6 weeks, and 3 months, as shown in Fig. 4.
The WOMAC scores for pain of the experimental group (13.29 ± 5.49) and control group (22.52 ± 5.47) were significantly different (p < 0.005) at 2 weeks, 6 weeks, and 3 months. The WOMAC movement scores of the experimental group (36.10 ± 13.78) and control group (63.52 ± 12.71) were significantly different (p < 0.001) at 2 weeks, 6 weeks, 3 months, and 6 months. The WOMAC scores for stiffness of the experimental group (6.03 ± 3.62) and control group (10.16 ± 3.42) were significantly different (p < 0.001) at 2 weeks. (Figs. 5).
Weight-Bearing on the left and right was not significantly different in the experimental group. The experimental group showed significant improvement in postural control in position (Left 16[8.5(6.5–14.0)] and Right 11[10.0(3.0–24.0)] ) when compared with that of the control group (Left 6[14.0(14.0–17.0)] and Right 22[24.0(13.0–30.0)] (p = 0.024), (p = 0.019)) at 2 weeks, 6 weeks, 3 months and 6 months. However, the anterior and posterior positions were not significantly different, as shown in Fig. 8.