Table 1.
Characteristics of included studies.
| First Author, Year |
Sample Size | Event Duration | Preparations and Doses | Guidance Techniques | Concomitant Rehabilitation | Control | Outcomes | Results |
|---|---|---|---|---|---|---|---|---|
| Burbaud. 1996 [13] |
23 | >3 months | Dysport®: 1000 U | EMG | All patients continued with active physiotherapy | placebo | Ashworth scale (AS) Fugl–Meyer score (FMS) Gait velocity (GV) Active dorsiflexion (AD) |
AS + FMS + GV – AD+ |
| Pittock. 2003 [16] |
234 | >3 months | Dysport®: 500 U, 1000 U, 1500 U |
None | 38% received physiotherapy, most only received 1 session | placebo/ dose-ranging |
Modified Ashworth Scale (MAS) Use of Walking Aids (WA) Gait velocity (GV) Active dorsiflexion (AD) Rivermead Motor Assessment (RMS) |
MAS + WA + GV – AD– RMS – |
| Mancini. 2005 [24] |
45 | 12–36 months |
Botox®: 160 U, 320 U, 540 U | EMG | Physical therapy was discontinued two months before the study and was suspended during the study period | dose-ranging | Modified Ashworth Scale Gait velocity Medical Research Council Scale |
Medium dosage is safe and effective |
| Kaji. 2010 [15] |
120 | >6 months | Botox®: 300 U | EMG | Rehabilitation programs were not specified | placebo | Modified Ashworth Scale (MAS) Gait velocity (GV) Clinical global impression (CGI) |
MAS + GV – CGI + |
| Dunne. 2012 [14] |
83 | >6 weeks | Botox®: 200 U, 300 U | EMG or ES | 41% of participants receiving unspecified physiotherapy at the time of study enrollment, not mentioned during the study period | placebo/ dose-ranging |
Ashworth Scale (AS) Gait quality (GQ) Leg spasms (LS) Active dorsiflexion (AD) |
AS – GQ + LS + AD + |
| Pimentel. 2014 [25] |
21 | >6 months | Botox®: 100U, 300 U | None | All participants underwent a rehabilitation program included PT (aquatic physiotherapy, motor physiotherapy to improve gait and range of motion), OT with the goal of training ADL, these programs were trained at least 4 days/ week for at least 40 minutes/day. | dose-ranging | Modified Ashworth Scale (MAS) | Improved spasticity in the 300U group was better than in the 100U group. |
| Fietzek. 2014 [19] |
52 | <3 months | Botox®: 230 U | None | All patients received the same standard multi-modal therapy, including PT, OT, ST, maximum of 300 min per day individualized for each patient | placebo | Modified Ashworth Scale (MAS) | MAS + |
| Tao. 2015 [20] |
23 | <6 weeks | Botox®: 200 U | EMG | Comprehensive rehabilitation combined neurodevelopmental technique and motor relearning program encompassing PT (45 minutes per day) OT (30 minutes per day) and gait training. | placebo | Modified Ashworth Scale (MAS) Fugl-Meyer score (FMS) Modified Barthel Index (MBI) Walking speed (WS) |
MAS + FMS + MBI + WS + |
| Jiang Li. 2017 [26] |
104 | NA | HengLi®: 200 U, 400 U. | ES | No rehabilitation program was recorded. | dose/ concentration ranging |
Modified Ashworth Scale Gait velocity |
400 U (100 U/ml) group showed better results. |
| Gracies. 2017 [23] |
388 | >6 months | Dysport®: 1000 U, 1500 U |
ES | No standardized physiotherapy regimen was associated with this protocol. | placebo/ dose-ranging |
Modified Ashworth Scale (MAS) Physician global assessment (PGA) Gait velocity (GV) |
MAS + PGA – GV – |
| Wein. 2018 [21] |
468 | >3 months | Botox®: 300–400 U |
EMG and/ or ES, ultrasound | No rehabilitation program was recorded. | placebo | Modified Ashworth Scale (MAS) Clinical Global Impression of Change (CGI) Goal Attainment Scale (GAS) |
MAS + CGI + GAS + |
| Kerzoncuf. 2019 [22] | 40 | >12 months |
Botox® < 300 U Mean:227 U |
ES | Patients continued their rehabilitation programs which were not systematically recorded. | placebo | Modified Ashworth Scale (MAS) Sway area (SA) Gait velocity (GV) Functional Ambulation Classification (FAC) Functional Independence Measure (FIM) |
MAS + SA + GV – FAC – FIM – |
The table shows the characteristics of selected studies. The characteristics of studies included the first author’s name and published year, the number of participants, event duration (NA: Not available), preparations and doses (U: unit) of BoNT-A, the use of injection guidance techniques (EMG: Electromyography, ES: electrical stimulation), concomitant rehabilitation program (PT: Physical therapy, OT: Occupational therapy, ST: Speech and language therapy), outcome measures, and results: (+) indicates significant improvements in the BoNT-A group compared to the placebo group, (–) indicates nonsignificant improvements in the BoNT-A group compared to the placebo group.