Werner 2016

Methods	Study design: cross‐over trial
Participants	Inclusion criteria: single history of CNS lesion due to stroke or traumatic brain injury; lesion interval > 12 months; increased muscle tone, i.e. 1, 2, 3, or 4 in the Modified Ashworth Score (0‐5) in affected wrist or finger joints; no volitional distal motor function of the affected arm, except for mass flexion; no metal implants or open wounds in the stimulation area; no deep vein thrombosis; no relevant oedema; no pacemaker; no preceding botulinum toxin injection within previous 6 months; signed written informed consent (approved by local ethics committee) Exclusion criteria: n/a Baseline characteristics Group 1 (rPMS‐sham) (n = 20) Age (years): 48 ± 9 Gender: 11 male, 9 female Type: 12 ischaemic stroke, 8 traumatic brain injury Paresis: 15 hemiparesis, 5 tetraparesis Time from onset (months): 23 ± 9 Group 2 (sham‐rPMS) (n = 20) Age (years): 55 ± 9 Gender: 13 male, 7 female Type: 13 ischaemic stroke, 7 traumatic brain injury Paresis: 15 hemiparesis, 5 tetraparesis Time from onset (months): 24 ± 6 Baseline comparability between 2 groups: group 1 was younger than group 2 Loss to follow‐up: 0%
Interventions	Intervention characteristics rPMS Frequency: 5 Hz Intensity: 60% Stimulation session: train duration of 3 seconds, and intertrain interval of 3 seconds Duration of stimulation (per session): 5 minutes of stimulation Number of stimulations (per session): 750 pulses Number of sessions in treatment: 1 Target of stimulation: forearm flexor muscles (wrist and metatarsophalangeal joints) Co‐exercise: manual muscle stretch of wrist and finger flexor muscles during stimulation Sham Frequency: 5 Hz Intensity: 0% (typical clicking sound was delivered but without releasing energy) Stimulation session: train duration of 3 seconds, and intertrain interval of 3 seconds Duration of stimulation (per session): 5 minutes of stimulation Number of stimulations (per session): 750 pulses Number of sessions in treatment: 1 Target of stimulation: forearm flexor muscles (wrist and metatarsophalangeal joints) Co‐exercise: manual muscle stretch of wrist and finger flexor muscles during stimulation
Outcomes	Spasticity: Modified Ashworth Score of wrist and finger (scores range from 0 to 4) Outcome type: ordinal Direction: lower is better Assessment time point: after intervention
Identification	Sponsorship source: n/a Country: Germany Setting: n/a Comments: The Verein zur Förderung der Hirnforschung und Rehabilitation, e.V., Berlin Authors' names: Werner C, Schrader M, Wernicke S, Bryl B, Hesse S Institution: Medical Park Berlin Humboldtmühle, Neurological Rehabilitation, Charité, University Medicine Berlin, Germany Email: c.werner@medicalpark.de Address: Medical Park Berlin Charité – University Medicine Berlin An der Mühle 2‐9, Berlin 13507, Germany
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Sequence generation was conducted with the help of a computer‐generated lot (www.randomizer.at)
Allocation concealment (selection bias)	Low risk	Before start of therapy, the sub‐investigator of the study attached the rPMS or sham coil according to group assignment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	This study used a sham coil delivered with an atypical clicking sound. Therapists who applied stimulation and muscle stretch were not aware of whether the coil used was the one intended for rPMS or sham
Blinding of outcome assessment (detection bias) All outcomes	Low risk	A rater, blinded to treatment allocation, assessed participants
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

CT: computed tomography ITT: intention‐to‐treat MRI: magnetic resonance imaging RCT: randomised controlled trial rPMS: repetitive peripheral magnetic stimulation