Nyfeller 2019.
Study characteristics | ||
Methods | RCT Setting: Switzerland, neurorehabilitation centre |
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Participants | 60 patients with a first, right hemispheric stroke participated in the study Age, years: sham = 70.6 ± 11.44, 8cTBS = 67.8 ± 10.13, 16cTBS = 74.3 ± 10.23 Sex (men/women): sham = 7/3, 8cTBS = 5/5, 16cTBS = 6/4 Time post stroke, days: sham = 25.8 ± 11.26, 8cTBS = 26.8 ± 20.89, 16cTBS = 22.9 ± 10.34 | |
Interventions | In brief, the cTBS protocol comprised 801 pulses, delivered in a continuous train of 267 bursts. Each burst consisted of 3 pulses at 30 Hz, repeated at 6 Hz. Duration of 1 single cTBS train was therefore 44 seconds In the 16cTBS group, the same daily protocol was repeated 4 times, i.e. 16 cTBS trains were applied over 4 days In the 8cTBS group, 8 cTBS trains were applied over 2 days. Four cTBS trains were applied on Day 1 (2 cTBS trains with an interval of 15 minutes, third and fourth cTBS trains 60 and 75 minutes after the first one, respectively (Cazzoli et al, 2012), and 4 cTBS trains on Day 2 ‐ same time intervals as for Day 1, repeated after 24 hours) Sham stimulation was applied with the same 8cTBS protocol as described above, except for use of a sham coil |
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Outcomes |
Assessed pre‐intervention, post intervention, and 3 months post intervention |
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Notes | We entered this study as Nyfeller 2019 8c TBS and Nyfeller 2019 16c TBS and spilt the control group across entries | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The randomisation procedure was carried out by a blinded collaborator (TP), using a computerised block randomisation protocol to ensure equal group sizes (https://www.random.org/ integer‐sets) |
Allocation concealment (selection bias) | Low risk | Treatment allocation was concealed from trained observers |
Blinding of participants | Low risk | “Double‐blind” |
Blinding of personnel | Unclear risk | Unclear |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | CBS was completed by rehabilitation nurses taking care of patients on a daily basis, who were blind with respect to the experimental protocol, and who observed patients performing different ADL. Unknown whether blinding was successful |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 3 dropped out at T2, unclear from which group though |
Selective reporting (reporting bias) | Low risk | Outcomes reported equally |
Other bias | Low risk | Nothing obvious |