Table 1 Result
Reference | Study design, country | sample, age in years, percent female (♀%) | Stroke severity measure | Intervention and severity characteristics | Delivered by | Outcome | Results |
|---|---|---|---|---|---|---|---|
Global early mobilisation within 24 h | |||||||
AVERT Trail Collaboration Group, 2015 [49]; | Parallel-group multicentre RCT Australia, New Zealand, Malaysia, Singapore, and the UK | n= 294 No information for severe stroke patients | NIHSS | Intervention very early mobilisation NIHSS >16 (n=147) Control usual care NIHSS >16 (n=147) | PTs and nurses | Favourable outcome (mRS 0-2) and mortality at 3 months | Subgroup analysis for severe stroke patients concerning mRS favours usual care over early mobilisation with an Odds Ratio of 0.35 (0.11–1.18). 88 (8%) patients died in the very early mobilisation group and 72 (7%) patients in the usual care group. |
Di Lauro et al., 2003 [57] | Individual RCT Italy | n= 60 Intervention 69,30 (±8,0) ♀ 62% Control 67,6 (±9,3) ♀ 55% | BI* | Intervention Intensive rehab group Mean BI 1.4 (±1.4) (n=29) Control Ordinary rehab group (n=31) Mean BI 1.5 (±1.5) | Therapists and nursing staff | BI, mNIHSS | No differences between groups in BI at 180 days (IG: 8.0±2.8; CG: 7.7±3.0; p>0.7) or NIHSS at 14 days (IG: 8.1±3.0; CG: 8.4±2.6; p>0.6) and at 180 days (IG: 6.2±2.8; CG: 6.5±2.7; p>0.7). |
Electrical Stimulation | |||||||
Guo and Kang, 2018 [65] | Individual RCT China | n= 82 Intervention 64.3 (±11.8) ♀ 46% Control 62.5 (±12.2) ♀ 39% | BI | Intervention NMES (n=38) Mean BI 10,5 (±2,2) Control sham NMES (n=36) Mean BI 10,8 (±2,6) | not described | BI, ICIQ-SF, OBASS, Urodynamic outcome | The results of the intervention group are more promising than the control group results in all outcomes: Urodynamic value (p<0,01), OABSS: IG: 8.1±3.4; CG: 12.3±3.0; p<0.01, c: IG 7.8±3.3; CG: 10.5±3.1; p<0.01, BI: IG:15.7±3.1; CG: 11.1±3.4; p<0.01. |
Rosewilliam et al., 2012 [72] | Individual RCT USA | n=90 entire sample 74,6 (±11,0) ♀ 56% | BI^ | Intervention NMES group (n=31) Mean BI 4.4 (±3.9) Control Usual care group (n=36) Mean BI 2.5 (±2.9) | NMES- staff group not reported, patients and carers, Usual care- PTs | ARAT, BI, wrist AROM, wrist strength, grip strength | No differences in ARAT, BI or wrist AROM between groups. Improvements in wrist extensor and grip strength in the NMES group post-intervention but not maintained at follow-up. |
Zheng et al., 2018 [66] | Individual RCT | n= 60 Intervention 59 (±11) ♀ 50% Control 1 60 (±9) ♀ 40% Control 2 59 (±9) ♀ 40% | mBI | Intervention four-channel FES group (n=18) Mean mBI 22 (±9) Control 1 dual-channel FES group (n=15) Mean mBI 23 (±13) Control 2 placebo group (n=15) Mean mBI 24 (±13) | PTs | mBI, FMA, PASS, BBS, BBA, mBI, fMRI | In favour of four-channel FES group showed fractional anisotropy and increased fibre bundles. No significance between-group differences. |
Mirror therapy | |||||||
Cui et al., 2022 [69] | Individual RCT China | n=32 Intervention 61.5±9.93 ♀ 44% Control 58.5±11.15 ♀ 50% | mBI | Intervention mirror therapy on lower leg (n=16), range mBI 21.50 (20.00, 25.75) Control routine rehabilitation (n=16), range mBI 22.50 (10.00, 27.75) | Therapists | FMA-LE, BBS, mBI, mRMI, rs-fMRI | A better effect for the mirror therapy group concerning FMA-LE (Z= -4,526,p<0,01), BBS (F = 36.985, p < 0.01), mMRI (F = 27.171, p < 0.01), mBI (F = 9.830, p = 0.004). |
Lee et al., 2020 [60] | Individual RCT Korea | n=21 Intervention 50.91 (±8.73) ♀ 38% Control 61.5 (±9.93) ♀ 28% | K-mBI | Intervention multi-joint-based mirror therapy (n=11), Mean K-mBI 23,73(± 7,70) Control single-joint based mirror therapy (n=10), Mean K-mBI 18,80 (± 7,22) | OTs | K-mBI, FMA, MAL | A favourable outcome for improving upper limb function (FMA-UE) and ADL in IG compared tcontrolrl. FMA-UE: IG:26.36±11.75; CG: 16.00 ±8.7; p= 0.034 MAL-QoM: IG: 20.91±12.8; CG: 12 ±6.2; p=0.034 MAL-AOU: IG: 17.64±72.8; CG: 11.4±6; p=0.048 mBI: IG: 26.55±5.71; CG: 19,4±7.18; p= 0.031 |
Sim and Kwon, 2022 [62] | Individual RCT Korea | n=30 Intervention 69.29 (±8.02) ♀ 33% Control 69.14 (±6.92) ♀ 36% | K-mBI | Intervention bimanual mirror therapy (n=14), Mean K-mBI 35.64 (±16.08) Control unimanual mirror therapy (n=14), Mean K-mBI 30.92 (±11.57) | OTs | MVPT, K-MMSE, BIT, K-CBS, K-mBI, SCT, LBT | In favour of the intervention group was found for SCT (p<0,05), PST (p<0,05), for LBT (p<0,05) and for K-CBS (p<0,05). No differences were found for K-mBI. |
Neurodevelopmental techniques | |||||||
Bai et al., 2014 [67] | Individual RCT China | n=165 Intervention 67,63 (±9,52) ♀ 38% Control 66.04 (±10,13) ♀ 38% | mBI | Intervention 1.-3. month of staged rehabilitation group (n=83) Mean BI 28 (range 24-31) Control Routine care group (n=82) Mean BI 23 (range 19-27) | PTs and OTs | mBI, mAS | IG demonstrated higher mBI scores than the routine care group at 1, 3- and 6 months post-stroke. IG: (M1 vs. M0, M3 vs. M1, M6 vs. M3, p< 0.01); CG: (M1 vs. M0, p <0.01; M3 vs. M1, p = 0.026) 42.9% of patients in the CG demonstrated spasticity in at least one body part compared to 36.4% of patients in the staged rehab group. |
Rahayu et al., 2020 [71] | Individual RCT Indonesia | n=64 Intervention 58.84 (±8.68) ♀ 38% Control 59.93 (±10.65) ♀ 50% | BI | Intervention Neurorestoration intervention (n=32) Mean BI 25.81 (±15.77) Control standard procedure (n=32) Mean BI 19,00 (± 10.29) | Research Assistant | BI, BNDF-Biomarker, BBS | In favour of intervention group for functional performance (BI: IG 67. 47 (58.99-75.94; CG: 46.41 (37.77-55.04); p=0.008) and balance (BBS: IG: 28.38 (21.74-35.01; CG:17.16 (12.62-21.69; p=0.016) in between group difference. No differences in neuroplasticity regeneration (p=0.07). |
Tang et al., 2014 [68] | Individual RCT China | n=48 Intervention 68,2 (±4,1) ♀ 29% Control 66,9 (±4,1) ♀ 33% | STREAM, BBS | Intervention Early contemporary Bobath group (n=24) Mean STREAM 1.4 (± 1.0), Mean BBS 0 (± 0) Control Contemporary group (n=24) Mean STREAM 1.3 (± 0.9), Mean BBS 0 (± 0) | PTs | STREAM, BBS | Improvements in STREAM (F (1, 46) = 11.7, η2 = 0.203, p < .01) and BBS (F (1, 46) = 35.4, ŋ2 = 0.435, p < .001) in the contemporary Bobath approach with early mobilisation group. |
Interventions for verticalization | |||||||
Bagley et al., 2005 [73] | Individual RCT UK | n= 140 Intervention 75,8 (±11,5) ♀ 29% Control 75,1 (±9,4) ♀ 31% | BI | Intervention Oswestry group (n=71) Median BI 1 (IQR 0-3) Control Control group (n=69) Median BI 2 (IQR 1-3) | PTs and nurses | RMI, BI, HADS NEADL, RMA, MAS (balance, sit-to-stand sections), TCT, CSI, GHQ-28 | No differences between groups for all outcome measures. No difference in the number of treatment sessions or stuff required for treatment. |
Calabró et al., 2015 [56] | Individual RCT Italy | n=32 Intervention 71 (±3) ♀ 60% Control 70 (±5) ♀ 50% | PASS, FMA-LL | Intervention Robotic verticalization group (n=10) Mean PASS 3 (±1), Mean LL FMA 13 (±3) Control Physiotherapy group (n=10) Mean PASS 3 (±3), Mean LL FMA 12 (±6) | PTs | PASS, FMA-LL, RCPM, MRC, vertical posture tolerance | Both interventions were well, tolerated. The robotic group demonstrated greater improvements compared to the physiotherapy group in: MRC (IG: 2±1; CG: 1±1; p=0,03); FMA (IG: 92±10; CG: 58±7; p=0.008) and PASS (IG: 166±30; CG: 66±2; p=0.008). Between-group differences for cognition were measured with RCPM of p=0.03. |
Logan et al., 2022 [74] | Individual RCT UK | n= 45 Intervention 81.7 (±11.7) ♀ 27% Control 78.9 (±10.5) ♀ 31% | mRS | Intervention Functional standing frame programme (n=22) mRS 4= 17; mRS 5= 5 Control usual physiotherapy (n=23) mRS 4= 19; mRS 5= 4 | PTs | Edmans ADL, BI, Goniometer, muscle strength, MAS, TCT, VAS for fatigue, PHQ-9, SADQ-10, EQ-5D 5L, Stroke and Aphasia QoL Scale-39 | It was a feasibility trial. It is not feasible in its current design. The intervention group showed some promising results on the BI for example at the 55th week with a Mean difference (95% CI) of 0,86 [-4.76, 6.49], and showed over time a ≥ 1.85 point minimal clinically important difference. |
Gait training interventions without electrical support | |||||||
Brunelli et al., 2019 [55] | Individual RCT Italy | n= 37 Intervention 69.64 (±10.88) Control 72.05 (±10.08) Overall ♀ 52% | FAC | Intervention BWS overground gait training (n=16), Mean BI 14.35 (±14.62) Control Gait training without BWS (n=21), Mean BI 14.42 (±15.72) | PTs | FAC, RMI, BI 6MWT | Patients in both groups improved continuously. No difference between groups (p>0.05) in independence in walking (FAC), or any secondary outcome (p>0.05). |
Kim et al., 2020 [46] | Individual RCT Korea | n= 22 Intervention 65.2 (11.9) ♀ 45% Control 61.4 (10.9) ♀ 18% | FAC | Intervention underwater gait training (n=10) FAC<3 Control overground gait training (n=11) FAC <3 | PTs | FAC, PASS, Balancia 2.0 program, GAITRite system | No favourable outcome for PASS, Postural control between the groups (p>0.05). The step length difference varied between groups, increased in IG and decreased in CG (IG: 4.55±6.68; CG: -1.25 ±3.56; p<0.05). |
Robotic-assisted gait training | |||||||
Chang et al., 2012 [61] | Individual RCT Korea | n= 48 Intervention 55,5 (±12) ♀ 29% Control 59,7 (±12.1) ♀ 29% | FAC, FMA-LL | Intervention Robot-assisted group (n=20) Mean FAC 0.5 (±0.5) Control Conventional group (n=17) Mean FAC 0.4 (±0.5) | PTs | FAC, LL MI, FMA-LL, Peak chang | Between-group differences for intervention group in FMA-LL (IG: 22.7 ±5.7; CG 19.6±5.6; p=0.037) and peak VO2 (l/min, IG:1.23±0.44; CG: 1.11±0.46; p=0.025). No improvements in LL MI (IG: 56.2±11.0; CG: 53.5±12; p= 0.200) and FAC (IG 0.5±0.5; CG: 1.4±0.8; p=0.232). |
Francesschini et al., 2009 [58] | Individual multicentre RCT Italy | n= 97 Intervention 65,5 (±12,2) ♀ 46% Control 70,9 (±11,8) ♀ 51% | BI* | Intervention Treadmill training group (n=52) Median BI 6 (IQR 3-9), Median FAC 0 (IQR 0-0) Control Conventional group (n=45) Median BI 5 (IQR 3-7), Median FAC 0 (IQR 0-0) | PTs | MI, TCT, mRS, BI, FAC, AS, LL proprioception, 6MWT, 10MWT, BS, WHS | No differences between groups. |
Louie et al., 2021 [75] | Individual multicentre RCT Canada | n= 36 Intervention 59.6 (15.8) ♀ 16% Control 55.3 (10.6) ♀ 41% | FAC | Intervention Exoskelet group (n=19), Median FAC 0 (0-1) Control usual physiotherapy group (n=17), Median FAC 0 (0-1) | PTs | FAC, 5MWT, 6MWT, FMA-LL, BBS, MoCA, SF-36 | No significant between-group differences for FAC. But significant effects for the intervention group on FMA-LL(as-treated adjusted group difference: 3.9, 95% CI 1.3–6.6, F(1,33) = 9.33, p = 0.004; per-protocol adjusted group differenci: 3.7, 95% CI 0.9–6.5, F(1,28) = 7.29, p = 0.01) and MoCA (as-treated adjusted group difference: 2.1, 95% CI 0.6–3.7, F(1,29) = 7.96, p = 0.009; per-protocol adjusted group difference: 2.0, 95% CI 0.4–3.6, F(1,25) = 6.62, p = 0.02). No further significant between-group differences in secondary outcomes. |
Ochi et al., 2015 [76] | Individual RCT Japan | n= 26 Intervention 61,8 (±7,5) ♀ 15% Control 65,5 (±12,1) ♀ 31% | FIM mobility, FAC | Intervention Robot-assisted treadmill gait training group (n=13) Median FAC 0 (IQR 0-1), Median FIM mobility 7 (IQR 6-10) Control Conventional group (n=13) Median FAC 1 (IQR 0-1), Median FIM mobility 7 (IQR 7-9) | Robot-assisted gait training not reported, conventional gait training PTS | FAC, FMA, LL muscle torque, 10MWT, FIM(mobility scores) | Robot-assisted gait training group demonstrated greater improvements in FAC (IG: 3 (3-4); CG: 3 (3-3); p=0.02) and peak LL muscle torque (IG: 0.37 (0.2-0.52); CG: 0.18 (0.09-0.23; p=0.05compared to the conventional group. |
Rodrigues et al., 2017 [70] | Individual RCT USA | n=20 Intervention 59,3 (±13,8) ♀ 50% Control 50,6 (±14,4) ♀ 40% | FMA-LL, FAC | Intervention Robot-assisted BWS treadmill gait training with increasing speed fast group (n=10) Median FAC 1.5 (1–2), Mean FMA-LL 19.5 (±4.6) Control Slower speed group (n=10) Median FAC 1 (1–2), Mean FMA-LL 17.5 (±2.8) | Not reported | FAC, TUG, 6MWT, 10MWT, BBS, FMA-LL | Improvements in FAC, FMA-LL, TUG and 6MWT in the slow group compared to the fast group. The fast group led to better outcomes on BBS. No between group difference is recorded. |
Thimabut et al., 2022 [77] | Individual RCT Japan | n=26 Intervention 52.8 (±12.6) ♀ 23% Control 62.8 (±8.5) ♀ 40% | BI | Intervention Robotic-assisted gait device (n=13), Mean BI 10 (±2.61) Control Control group (n=13), Mean BI 11.23 (±2.31) | PTs | FIM walking, 6MWT, mBI, gait parameters (Xsens) | In favour of the intervention group for FIM walk score in between-group comparison at the end of the 15th session (5.00±1.29 vs 3.46±1.76, P=.012), but no differences were detected at the second half. No differences for the 6MWT. But between-group differences for ADLs (BI: (7.31±1.89 vs 4.62±0.96, P<.001). |
Diverse interventions | |||||||
An et al., 2021 [64] | Individual RCT Korea | n=30 Intervention 60,5 (±6,0) ♀ 27% Control 64.7 (±6,9) ♀ 30% | k-mBI | Intervention whole-body tilting postural training (n=15), Mean K-mBI 23,4 (±8,0) Control General postural training group (n=15), Mean K-mBI 17,8 (±11,1) | PT | BLS, PASS,K-mBI, BBS, FMA-LL | All outcomes showed a significant between-group difference in favour for the intervention group. |
Chen et al., 2011 [78] | Individual RCT Taiwan | n=35 Intervention 58,0 (±11,5) ♀ 23% Control 62,3 (±11,35) ♀ 43% | FAC, FMA-LL | Intervention Thermal stimulation group (n=17) Median FAC 0 (IQR 0-1), Median LL FMA 7 (4-11.5) Control Standard rehab group (n=16) Median FAC 0 (IQR 0-1), Median LL FMA 6 (4.3-12.0) | Thermal-stimulation- PTs | FMA-LL, MRC-LL, mMAS, PASS (trunk control items), BBS, FAC | Thermal stimulation group demonstrated greater recovery gains compared to standard care in all outcomes except PASS. FMA-LL: IG: 14(10.5-15.5); CG:6.0(3-9.8); p <0.001 MRC-LL: IG: 6(4-7);CG: 3(1.3-4); p<0.001 mMAS: IG 16(12.5-18.5); CG: 10.5(5.3-14); p=0.01 BBS: IG: 28(20.5-33.5); CG: 15.5(9.3-23.5); p=0.007 FAC: IG: 2(2—2); CG: 1(1-1); p<0.001 |
Choi et al., 2021 [59] | Individual RCT Korea | n=24 Intervention 63.00 (±10.02) ♀ 58% Control 61.58 (±9.99) ♀ 50% | mBI | Intervention Digital Practice group (n=12) Mean mBI 37.42 (±8.73) Control Control group (n=12) Mean mBI 38.08 (±9.80) | Therapists | LBT, CBS, MVPT-V, head-tracking sensor data, mBI | Digital practice with VR rehabilitation system led to greater recovery of self-awareness of behavioural neglect, cognitive and visual perception. Between-group differences in LBT-score (IG: 11.75±5.83; CG: 9.67±6.61; p=0.02). No differences in mBI (p=0.52) and CBS (p=0.143). |
Katz-Leurer et al., 20003 [79] | Individual RCT Israel | n=92 Intervention 65,5 (±12,2) ♀ 48% Control 70,9 (±11,8) ♀ 46% | SSS | Leg cycle ergometer and regular rehabilitation groups- actual number of patients with severe stroke (SSS <30) not reported | Leg cycle ergometer- PTs | FAI | No differences in FAI between groups. |
Kim et al., 2022 [63] | Individual RCT Korea | n=41 Intervention 64.76 (±12.80) ♀ 38% Control 63.60 (±14.46) ♀ 50% | K-mBI | Intervention Elastic dynamic shoulder sling group (n=21) Mean K-mBI 35.00 (±17.85) Control Bobath sling group (n=20) Mean K-mBI 30.90 (±20.50) | Not further defined | X-Ray, FMA, K-mBI, VAS pain, MAD, MMT | There was a significant between-group difference (-0,80±3,11 vs. 2,28±3,66, p=0,006) in favour of the intervention group. No further differences had been detected. |
Individual RCT Netherlands | n=101 Intervention 2 64,1 (±15,0) ♀ 62% Intervention 2 69 (±9,8) ♀ 52% Control 64,5 (±9,7) ♀ 58% | BI | Intervention 1 (IG-A) UL training group (n=33) Median BI 5 (IQR 3-7) Intervention 2 (IG-L) LL training (n=31), Median BI 6 (IQR 3-8) Control Splint control group (n=37), Median BI 5.5 (IQR 3-7) | PTs and OTs | BI, FAC, ARAT, 10MWT, SIP, NHP, FAI | UL training group had significantly higher ARAT than the splint control group post-intervention. LL training group had significantly higher BI, FAC, walking speed and ARAT than the splint control group post-intervention. No significant differences in all outcomes were seen between groups from 6 months onwards up until the 12-month follow-up. ADL 6 weeks: IG-L: 13(8.75-19); IG-A: 10(5-13); p< 0.05) FAC: IG-L: 3(2-4); IG-A: 2(1-3); p<0.05 ARAT: IG-A: 3 (0-34), CG: 0 (0-1); p<0.05 | |
Lincoln et al., 1999 [53] | Individual RCT UK | n=282 Intervention 73(64-80) ♀ 53% Control 1 73 (65-91) ♀ 46% Control 2 73 (66-80) ♀ 48% | BI^ | Intervention Qualified PT group (n=94) Median BI 6 (IQR 3-9) Control 1 PTA group (n=93) Median BI 6 (IQR 4-8) Control 2 Standard PT group (n=95) Median BI 7 (IQR 3-9) | PTs/ PTAs | RMA- arm scale, ARAT, THPT, grip strength, mAS, BI, MCA | No differences between the groups across all outcomes. |
Shao et al., 2023 [54] | Individual RCT China | n=139 Intervention 64.56 (±7.08) ♀ 23% Control 65.72 (±5.95) ♀ 40% | NIHSS | Intervention Strength training group (n=69) Median NIHSS 16.25 (±3.69) Control Usual physiotherapy group (n=70) Median NIHSS 15.97 (±3.30) | Not further defined | BBS, 6MWT, mBI, max. muscle strength | There are significant between-group differences for BBS (adjusted: 40.30±0.75 vs. 33.47±0.74; mean difference (95% CI) 6.83 (4.71 8.94); ɳ2= 0.24; p <0.001) and 6MWT (adjusted: 196.82±3.48 vs. 146.45±3.45, mean difference (95% CI) 50.32 (40.58 60.05); ɳ2= 0.45; p <0.001). The comparison of the gain of muscle strength of hemiplegic limbs was in favour of the intervention group (p=0,01). |