Krewer 2014

Methods	Study design: RCT Study grouping: parallel group
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 rPMS (n = 31) Age (years): 55 ± 13 Gender: 19 male, 12 female Type: 28 stroke, 3 traumatic brain injury Location of stroke: 18 right, 13 left Time from onset (weeks): 26 ± 71 Sham (n = 32) Age (years): 54 ± 13 Gender: 19 male, 13 female 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 rPMS 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 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 outcome 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: Cambridge Electronic Design Limited, Unit 4, Science Park, Milton Rd, Cambridge, CB4 0FE, UK. MAG&More GmbH,Geisenhausenerstrasse 11A, 81379 Munich, Germany 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