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. 2019 Nov 30;2019(11):CD011968. doi: 10.1002/14651858.CD011968.pub3

Krewer 2014.

Methods Study design: RCT
Study grouping: parallel groups
Participants Inclusion criteria: hemiparesis caused by stroke or traumatic brain injury; spasticity of an upper extremity, with a score of 1 to 3 on the Tardieu Scale; ages between 18 and 75 years
Exclusion criteria: metal implant in the head or within the stimulation area; medically implanted device (cardiac pacemaker, cochlear implant, or medication pump); pregnancy; comorbidity with other neurodegenerative disorders or other neurological or orthopaedic disorders; increased intracranial pressure; unstable fracture of the paretic upper extremity
Baseline characteristics
Active rPMS plus rehabilitation (n = 31)
  • Age, years: 55 ± 13

  • Gender: 19 men, 12 women

  • Type: 28 stroke, 3 traumatic brain injury

  • Location of stroke: 18 right, 13 left

  • Time from onset, weeks: 26 ± 71


Sham rPMS plus rehabilitation (n = 32)
  • Age, years: 54 ± 13

  • Gender: 19 men, 13 women

  • Type: 32 stroke

  • Location of stroke: 15 right, 17 left

  • Time from onset, weeks: 37 ± 82


Baseline comparability between 2 groups: only rPMS groups included traumatic brain injury; rPMS group earlier from onset than sham group
Loss to follow‐up: 0.05%; ITT analysis was performed
Interventions Intervention characteristics
Active rPMS plus rehabilitation
  • Frequency: 25 Hz

  • Intensity: 10% above the level that evoked movement taken at rest

  • Stimulation session: train duration of 1 second, and intertrain interval of 2 seconds

  • Duration of stimulation (per session): 20 minutes

  • Number of stimulations (per session): 5000 pulses

  • Number of sessions in treatment: 20 (2 times a day, 5 times a week, for 2 weeks)

  • Target of stimulation: extensors and flexors of the upper and lower arm

  • Co‐exercise: 20 minutes of occupational therapy after each stimulation


Sham rPMS plus rehabilitation
  • Frequency: n/a

  • Intensity: 0% (using non‐active coil; active coil makes typical discharge noises)

  • Stimulation session: train duration of 1 second, and intertrain interval of 2 seconds

  • Duration of stimulation (per session): 20 minutes

  • Number of stimulations (per session): 5000 pulses

  • Number of sessions in treatment: 20 (2 times a day, 5 times a week, for 2 weeks)

  • Target of stimulation: extensors and flexors of the upper and lower arm

  • Co‐exercise: 20 minutes of occupational therapy after each stimulation

Outcomes Activities of daily living: Barthel Index (scores range from 0 to 100)
  • Outcome type: continuous

  • Direction: higher is better

  • Assessment time point: after 2 weeks of therapy, 2 weeks after intervention phase


Upper limb function: Fugl‐Meyer Assessment (scores range from 0 to 66)
  • Outcome type: continuous

  • Direction: higher is better

  • Assessment time point: after 2 weeks of therapy, 2 weeks after intervention phase


Spasticity: Modified Tardieu Scale of elbow and wrist (scores range from 0 to 5)
  • Outcome type: ordinal

  • Direction: lower is better

  • Assessment time point: after 2 weeks of treatment, 2 weeks after treatment phase

Identification Sponsorship source: n/a
Country: Germany
Setting: neurological rehabilitation hospital
Authors' names: Carmen Krewer, Sandra Hartl, Friedemann Muller, Eberhard Koenig
Institution: Schoen Klinik Bad Aibling, Motor Research Department, Bad Aibling, Germany
Email: CKrewer@schoen‐kliniken.de
Address: Schoen Klinik Bad Aibling, Kolbermoorer Strasse 72, D‐83043 Bad Aibling, Germany
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information
Allocation concealment (selection bias) Low risk Randomised allocation was done by an individual not involved in any other part of the study
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Active coil makes typical discharge noises. Blinding of participants and personnel was enough
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Trained therapists, blinded for treatment allocation, assessed each participant
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Loss to follow‐up 5%; no differences in reasons why outcome data were missing
Selective reporting (reporting bias) Unclear risk Protocol was not available
Other bias Low risk No other biases