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. 2017 Jun 23;2017(6):CD011968. doi: 10.1002/14651858.CD011968.pub2
Methods Study design: RCT
Study grouping: parallel group
Participants Inclusion criteria: chronic unilateral, first‐ever stroke more than 12 months before the start of the study. Participants with stroke presented with paretic ankle muscles with spasticity (medical records), had a CT or MRI scan taken within the previous 5 years, and were able to walk independently (i.e. with no physical assistance) more than 10 m with or without an assistive device
Exclusion criteria: use of antispastic medication; past vertebral surgery; major circulatory, respiratory, or cardiac disease; neurological disease/deficit other than stroke; severe lower limb orthopaedic condition; or cognitive disorder
Baseline characteristics
rPMS (n = 9)
  • Age (years): 51 ± 15

  • Gender: 4 male, 5 female

  • Type: 8 ischaemic stroke, 1 haemorrhagic stroke

  • Location of stroke: 4 right, 5 left

  • Time from onset (months): 53 ± 37


Sham (n = 9)
  • Age (years): 55 ± 11

  • Gender: 3 male, 6 female

  • Type: 8 ischaemic stroke, 1 haemorrhagic stroke

  • Location of stroke: 5 right, 4 left

  • Time from onset (months): 83 ± 101


Baseline comparability between 2 groups: rPMS group was earlier from onset than sham group
Loss of follow‐up: 0%
Interventions Intervention characteristics
rPMS
  • Frequency: theta‐burst frequency (i.e. 5 Hz bursts of three 50‐Hz pulses each)

  • Intensity: 42% of maximal stimulator output

  • Stimulation session: Intermittent theta‐burst stimulation of 2 seconds ON, 8 seconds OFF

  • Duration of stimulation (per session): 190 seconds

  • Number of stimulations (per session): 600 pulses

  • Number of sessions in treatment: 1

  • Target of stimulation: paretic tibialis anterior muscle

  • Co‐exercise: none


Sham
  • Frequency: theta‐burst frequency (i.e. 5 Hz bursts of three 50‐Hz pulses each)

  • Intensity: 5% of maximal stimulator output

  • Stimulation session: intermittent theta‐burst stimulation of 2 seconds ON, 8 seconds OFF

  • Duration of stimulation (per session): 190 seconds

  • Number of stimulations (per session): 600 pulses

  • Number of sessions in treatment: 1

  • Target of stimulation: paretic tibialis anterior muscle

  • Co‐exercise: none


Sham stimulation was applied using the same parameters but at a very low intensity
Outcomes Muscle strength: dorsiflexion strength (kg)
  • Outcome type: continuous

  • Direction: higher is better

  • Assessment time point: post intervention

Identification Sponsorship source: Canadian Foundation for Innovation (CS) and studentships from the Fondsde la Recherche en Sante du Quebec (LDB, HMA) and the Canadian Institutes for Health Research (LDB, HMA)
Country: Canada
Setting: n/a
Authors' names: Louis‐David Beaulieu, Hugo Masse‐Alarie, Brenda Brouwer, Cyril Schneider
Institution: Laboratoire de Neurostimulation et Neurosciences Cliniques
Email: cyril.schneider@rea.ulaval.ca
Address: Centre de recherche du CHU de Quebec, Axe Neurosciences RC‐9800, 2705 Boulevard Laurier, Quebec, QC G1V 4G2, Canada
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information
Allocation concealment (selection bias) Unclear risk No information
Blinding of participants and personnel (performance bias) All outcomes Low risk To ensure blinding, all participants were informed at enrolment that they could receive real rPMS or sham stimulation over the paretic lower limb, but they were not provided with information about the location of the coil or sensations induced by stimulation
Blinding of outcome assessment (detection bias) All outcomes Low risk Experimenters performing pre‐ and post‐intervention measures and analysis had to leave the room during the intervention and remained blind to group allocation during the experiments and to times of measurement during analysis (i.e. pre‐ or post‐intervention) until completion of analyses
Incomplete outcome data (attrition bias) All outcomes Low risk Loss to follow‐up: 0%
Selective reporting (reporting bias) Unclear risk Protocol was not available
Other bias Low risk No other biases