Efficacy of Robot-Assisted Gait Training Combined with Robotic Balance Training in Subacute Stroke Patients: A Randomized Clinical Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Participants’ Recruitment
2.2. Randomization
2.3. Therapeutic Interventions
- Exercises in static mode with the blocked “seat platform” or “floor platform” where the patient is positioned as still as possible in the Closed Eyes (CE) and Open Eyes (OE) condition;
- Exercises in dynamic mode with the unblocked “seat platform” or “floor platform” where the patient is positioned as still as possible;
- Exercises in dynamic mode (the “seat platform” or “floor platform are unblocked along one or more axis).
2.4. Clinical Evaluation and Instrumental Assessments
2.5. Safety and Possible Side-Effects during Study Participation
2.6. Statistical Analysis
3. Results
3.1. Sample
3.2. Clinical Outcomes
3.3. Instrumental Outcomes
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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A: Characteristics | |||
GG | GTG | p-value | |
n (%) Mean ± SD | |||
Subjects | 17 (47.20) | 19 (52.80) | |
Gender. Male/Female | 9 (52.94)/8 (47.06) | 12 (63.16)/7 (36.84) | 0.616 |
Age (years) | 66.64 ± 9.61 | 66.11 ± 8.76 | 0.778 |
Time post the acute event (days) | 119.9 ± 38.9 | 134.3 ± 36.1 | 0.129 |
Aetiology. Ischemic/Haemorrhagic | 9 (52.94)/8 (47.06) | 13 (68.42)/6 (31.58) | 0.265 |
Lesion Side. Left/Right | 10 (58.82)/7 (41.18) | 10 (52.64)/9 (47.36) | 0.754 |
B: Clinical Outcomes at T0 | |||
GG | GTG | p-value | |
Median [25th;75th percentiles] | |||
MI-LL | 42 [27–66] | 53 [42–75] | 0.285 |
MAS-LL | 2 [1–4] | 2 [0–4] | 0.531 |
FAC | 0 [0–1] | 1 [0–2] | 0.165 |
TIN-B | 8 [6–9] | 11 [4–14] | 0.219 |
BBS | 13 [8–27] | 22 [8–38] | 0.452 |
TCT | 61 [37–62] | 61 [37–74] | 0.639 |
WHS | 1 [1–1] | 1 [1–2] | 0.066 |
10 MWT velocity m/s | 0.44 [0.33–0.67] | 0.30 [0.17–0.42] | 1.000 |
6 MWT distance (m) | 117 [44–154] | 72 [25–144] | 0.539 |
AI | 1 [0–1] | 1 [1–2] | 0.076 |
TUG time (s) | 24 [16–36] | 29 [22–47] | 0.373 |
BI | 36 [22–50] | 42 [26–67] | 0.330 |
NRS | 4 [1–6] | 3 [0–5] | 0.415 |
ID PAIN | 1 [0–2] | 0 [−1–2] | 0.232 |
GG | GTG | p Value (%∆_GG vs. GTG) | |||||
---|---|---|---|---|---|---|---|
T0 Median (IQR) | T1 Median (IQR) | p Value (T0 vs. T1) | T0 Median (IQR) | T1 Median (IQR) | p Value (T0 vs. T1) | ||
MI-AD | 14 (9–19) | 14 (9–25) | 0.068 | 14 (14–25) | 25 (14–33) | 0.010 | 0.346 |
MI-KE | 14 (9–25) | 19 (12–25) | 0.059 | 14 (14–25) | 25 (14–33) | 0.005 | 0.100 |
MI-HF | 14 (9–25) | 25 (9–25) | 0.126 | 19 (14–25) | 25 (19–33) | 0.011 | 0.433 |
MI-LL | 42 (27–66) | 58 (32–70) | 0.065 | 53 (42–75) | 72 (47–91) | 0.002 | 0.156 |
MAS-H | 0 (0–2) | 0 (0–1) | 0.083 | 0 (0–1) | 0 (0–0) | 0.096 | 0.754 |
MAS-K | 0 (0–1) | 0 (0–1) | 0.582 | 0 (0–1) | 0 (0–0) | 0.038 | 0.490 |
MAS-A | 1 (0–2) | 1 (1–2) | 0.558 | 1 (0–2) | 1 (0–2) | 0.102 | 0.802 |
MAS-LL | 2 (1–4) | 2(1–3) | 0.277 | 2 (0–4) | 1 (0–3) | 0.026 | 0.552 |
FAC | 0 (0–1) | 1 (1–3) | 0.004 | 1 (0–2) | 2 (1–4) | 0.000 | 0.684 |
TIN-B | 8 (6–9) | 11 (7–14) | 0.021 | 11 (4–14) | 12 (8–16) | 0.004 | 0.975 |
BBS | 13 (8–27) | 24 (10–36) | 0.007 | 22 (8–38) | 31 (12–48) | 0.003 | 0.900 |
TCT | 61 (37–62) | 62 (37–80) | 0.018 | 61 (37–74) | 74 (49–100) | 0.009 | 0.778 |
WHS | 1 (1–1) | 1 (1–2) | 0.010 | 1 (1–2) | 2 (1–4) | 0.020 | 0.616 |
10 MWT | 0.44 (0.33–0.67) | 0.49 (0.30–0.75) | 0.500 | 0.30 (0.17–0.42) | 0.37 (0.26–0.53) | 0.575 | 0.093 |
6 MWT | 117 (44–154) | 175 (51–328) | 0.068 | 72 (25–144) | 119 (71–195) | 0.007 | 0.839 |
AI | 1 (0–1) | 3 (1–5) | 0.001 | 1 (1–2) | 3 (3–3) | 0.000 | 0.616 |
TUG | 24 (16–36) | 17 (7–35) | 0.593 | 29 (22–47) | 21 (14–39) | 0.015 | 1.000 |
BI | 36 (22–50) | 52 (44–71) | 0.001 | 42 (26–67) | 68 (45–80) | 0.000 | 0.684 |
NRS | 4 (1–6) | 2 (0–4) | 0.018 | 3 (0–5) | 2 (0–4) | 0.178 | 0.300 |
ID PAIN | 1 (0–2) | 1 (−0–1) | 0.174 | 0 (−1–2) | 0 (0–1) | 0.796 | 0.397 |
GG | GTG | p Value (%∆_GG vs. GTG) | |||||
---|---|---|---|---|---|---|---|
T0 Median (IQR) | T1 Median (IQR) | p Value (T0 vs. T1) | T0 Median (IQR) | T1 Median (IQR) | p Value (T0 vs. T1) | ||
CoP sway Area OE [cm2] | 0.2 (0.1–1.2) | 0.2 (0.1–0.5) | 0.756 | 0.2 (0.2–0.5) | 0.2(0.1–1.0) | 0.959 | 0.897 |
CoP sway Area CE [cm2] | 0.2 (0.0–0.6) | 0.1 (0.05–0.3) | 0.605 | 0.1(0–1.2) | 0.1(0.0–0.4) | 0.469 | 0.669 |
CoP sway Path OE [cm] | 8.4 (3.5–13.5) | 8.2 (4.4–14.65) | 0.438 | 9.5 (5.5–12.3) | 7.9(6.6–11.9) | 0.796 | 0.287 |
CoP sway Path CE [cm] | 7.3 (3.4–10.2) | 7.6 (4.3–11.2) | 0.959 | 7.7 (4.0–11.3) | 7.2 (6.0–8.8) | 0.569 | 1.000 |
Romberg Index | 2.7 (1.6–5.2) | 1.7 (1.1–4.5) | 0.469 | 2.5 (1.5–4.0) | 2.6 (1.2–13.3) | 0.535 | 0.491 |
CoP Oscillation AP OE [cm] | 0.7 (0.3–1.3) | 0.7 (0.4–1.1) | 0.501 | 0.9 (0.7–1.4) | 0.6 (0.3–1.1) | 0.408 | 0.184 |
CoP Oscillation AP CE [cm] | 0.5 (0.3–0.8) | 0.6 (0.4–1.2) | 0.234 | 0.9 (0.5–1.9) | 0.7 (0.4–1.7) | 0.352 | 0.184 |
CoP Oscillation ML OE [cm] | 0.7 (0.3–1.2) | 0.6 (0.4–0.9) | 0.959 | 0.8 (0.5–1.4) | 0.5 (0.4–1.0) | 0.352 | 0.515 |
CoP Oscillation ML CE [cm] | 0.7 (0.3–1.1) | 0.6 (0.3–0.9) | 0.379 | 0.5 (0.4–1.4) | 0.6 (0.4–0.9) | 0.959 | 0.724 |
Ellipse axes ratio OE [%] | 45.5 (41.4–61) | 50.7 (34.6–57.3) | 0.756 | 50.1 (32.2–63.6) | 46.0 (40.1–50.4) | 0.569 | 0.809 |
Ellipse axes ratio CE [%] | 44.0 (36.9–57.6) | 40.7 (28.4–55.8) | 0.234 | 52.5 (46.6–66.3) | 48.5 (40.4–53.8) | 0.109 | 0.616 |
CoP Mean velocity AP OE [cm/s] | 0. 3 (0.1–0.5) | 0.3 (0.2–0.5) | 0.756 | 0.4 (0.2–0.5) | 0.3 (0.2–0.4) | 0.717 | 0.361 |
CoP Mean velocity AP CE [cm/s] | 0.3 (0.1–0.4) | 0.3 (0.1–0.4) | 0.836 | 0.3 (0.2–0.5) | 0.3 (0.2–0.3) | 0.650 | 0.402 |
CoP Mean velocity ML OE [cm/s] | 0.29 (0.17–0.54) | 0.32 (0.21–0.56) | 0.379 | 0.35(0.25–0.47) | 0.32 (0.26–0.54) | 0.600 | 0.047 |
CoP Mean velocity ML CE [cm/s] | 0.3 (0.2–0.4) | 0.3 (0.2–0.4) | 0.918 | 0.3 (0.2–0.4) | 0.3 (0.2–0.4) | 0.753 | 0.491 |
Trunk Displacement OE [deg2] | 0.04 (0.03–0.1) | 0.04 (0.03–0.05) | 0.877 | 0.04 (0.03–0.05) | 0.04 (0.03–0.06) | 0.733 | 0.520 |
Trunk Displacement CE [deg2] | 0.03 (0.03–0.04) | 0.03 (0.03–0.04) | 0.605 | 0.03 (0.03–0.05) | 0.03 (0.03–0.04) | 0.233 | 0.572 |
Trunk Oscillation AP OE [deg] | 3.0 (1.6–4.0) | 3.3 (2.3–4.3) | 0.918 | 3.4 (2.2–7.4) | 3.3 (1.8–6.5) | 0.691 | 0.545 |
Trunk Oscillation AP CE [deg] | 2.9 (1.3–3.5) | 3.3 (2.2–5.3) | 0.056 | 2.9 (1.5–5.7) | 3.4 (2.5–4.4) | 0.650 | 0.264 |
Trunk Oscillation ML OE [deg] | 1.8 (0. 9–4.1) | 2.2 (1.2–4.4) | 0.352 | 1.8 (1.3–2.3) | 2.2 (1.2–3.9) | 0.955 | 0.520 |
Trunk Oscillation ML CE [deg] | 1.6 (0.9–4.6) | 1.9 (1.2–2.8) | 0.959 | 2.2 (1.0–3.1) | 1.9 (1.4–2.9) | 0.910 | 1.000 |
GG | GTG | ||||||
---|---|---|---|---|---|---|---|
T0 Median (IQR) | T1 Median (IQR) | p Value (T0 vs. T1) | T0 Median (IQR) | T1 Median (IQR) | p Value (T0 vs. T1) | p Value (%∆_GG vs. GTG) | |
CoP swayArea OE [cm2] | 125.3 (18.5–573.4) | 235.7 (57.6–383.5) | 0.717 | 392.4 (43.2–512.1) | 79.7 (5.6–426.7) | 0.281 | 0.140 |
CoP swayArea CE [cm2] | 170 (43.7–431.7) | 137.5 (50.2–327.1) | 0.918 | 301.3 (69.3–677.8) | 92 (4.3–248.1) | 0.017 | 0.086 |
CoP sway Path OE [cm] | 41.3 (21.1–82.4) | 50 (35.8–75.2) | 0.501 | 67.7 (22.1–85.0) | 43 (10.2–72.5) | 0.156 | 0.140 |
CoP sway Path CE [cm] | 50.8 (28.8–82.2) | 37.4 (29–74.6) | 0.836 | 68 (42.9–99.6) | 31.5 (9.1–72.3) | 0.078 | 0.188 |
Romberg Index | 1.4 (0.6–3.6) | 3.5 (1.7–5.1) | 0.098 | 2.3 (1.0–5.0) | 1.8 (0.6–4.7) | 0.650 | 0.247 |
CoP Oscillation AP OE [cm] | 10.7 (5–15.1) | 11.1 (7.4–17.5) | 0.569 | 14.4 (6.8–20.3) | 7.1 (2.5–18.3) | 0.112 | 0.101 |
CoP Oscillation AP CE [cm] | 9.5 (5.2–18.2) | 11.9 (6.8–15.1) | 1.000 | 14.1 (7.1–17.6) | 7.7 (3.2–10.6) | 0.023 | 0.078 |
CoP Oscillation ML OE [cm] | 14.3 (6.2–19.8) | 18.4 (10.3–21.2) | 0.501 | 19.7 (9.4–29.3) | 14.1 (2.5–18.3) | 0.012 | 0.072 |
CoP Oscillation ML CE [cm] | 18.9 (12.3–24.4) | 17 (7.8–24) | 0.756 | 21.8 (9.9–28.2) | 13.5 (3.7–18) | 0.041 | 0.216 |
Ellipse axes ratio OE [%] | 33.3 (14.3–44.8) | 32.9 (17.7–37.5) | 0.605 | 24.9 (18.6–39.3) | 29.7 (23.2–40.9) | 0.427 | 0.545 |
Ellipse axes ratio CE [%] | 33.7 (20.1–46.2) | 28.4 (19.3–36.7) | 0.352 | 37.4 (24.9–50.5) | 39.1 (26.3–50.3) | 0.427 | 0.830 |
CoP Mean velocity AP OE [cm/s] | 1.5 (0.7–2.2) | 1.9 (0.7–2.2) | 0.570 | 1.5 (0.7–2.8) | 1.2 (0.3–2.3) | 0.140 | 0.299 |
CoP Mean velocity AP CE [cm/s] | 1.2 (0.8–2.2) | 1.4 (0.8–2.4) | 0.865 | 1.7 (0.8–2.6) | 0.9 (0.3–1.5) | 0.036 | 0.140 |
CoP Mean velocity ML OE [cm/s] | 2.1 (0.6–3.4) | 2.2 (1.2–4) | 0.776 | 2.9 (0.7–4.9) | 2.2 (0.3–3.3) | 0.233 | 0.830 |
CoP Mean velocity ML CE [cm/s] | 2.4 (1.2–3.3) | 1.8 (0.8–3.2) | 0.820 | 3.1 (2.1–4.0) | 1.4 (0.2–3.9) | 0.125 | 0.599 |
Trunk Displacement OE [deg2] | 0.12 (0.08–0.20) | 0.12 (0.09–0.14) | 0.379 | 0.123 (0.084–0.204) | 0.120 (0.090–0.141) | 0.009 | 0.131 |
Trunk Displacement CE [deg2] | 0.09 (0.06–0.14) | 0.09 (0.06–0.13) | 0.326 | 0.092 (0.062–0.140) | 0.091 (0.060–0.138) | 0.004 | 0.038 |
Trunk Oscillation AP OE [deg] | 12.6 (7–19.2) | 12.8 (8.6–15.3) | 0.535 | 14.6 (6.5–18.5) | 7.1 (3.2–11.6) | 0.006 | 0.038 |
Trunk Oscillation AP CE [deg] | 11.8 (7–16.4) | 11 (5.6–16.2) | 0.642 | 12.4 (7.6–16.5) | 6 (3.4–10.5) | 0.022 | 0.028 |
Trunk Oscillation ML OE [deg] | 11.5 (6.9–20.8) | 11.3 (7.5–17) | 0.877 | 12 (9.2–18.3) | 6 (2.3–10.1) | 0.026 | 0.101 |
Trunk Oscillation ML CE [deg] | 9.6 (6–15.4) | 9.8 (3.9–17.7) | 0.642 | 10.2(6.1–21.9) | 4.9 (2–11.4) | 0.056 | 0.110 |
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Aprile, I.; Conte, C.; Cruciani, A.; Pecchioli, C.; Castelli, L.; Insalaco, S.; Germanotta, M.; Iacovelli, C. Efficacy of Robot-Assisted Gait Training Combined with Robotic Balance Training in Subacute Stroke Patients: A Randomized Clinical Trial. J. Clin. Med. 2022, 11, 5162. https://doi.org/10.3390/jcm11175162
Aprile I, Conte C, Cruciani A, Pecchioli C, Castelli L, Insalaco S, Germanotta M, Iacovelli C. Efficacy of Robot-Assisted Gait Training Combined with Robotic Balance Training in Subacute Stroke Patients: A Randomized Clinical Trial. Journal of Clinical Medicine. 2022; 11(17):5162. https://doi.org/10.3390/jcm11175162
Chicago/Turabian StyleAprile, Irene, Carmela Conte, Arianna Cruciani, Cristiano Pecchioli, Letizia Castelli, Sabina Insalaco, Marco Germanotta, and Chiara Iacovelli. 2022. "Efficacy of Robot-Assisted Gait Training Combined with Robotic Balance Training in Subacute Stroke Patients: A Randomized Clinical Trial" Journal of Clinical Medicine 11, no. 17: 5162. https://doi.org/10.3390/jcm11175162