Krewer 2014.
Methods |
Study design: RCT Study grouping: parallel groups |
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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)
Sham rPMS plus rehabilitation (n = 32)
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 |
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Interventions |
Intervention characteristics Active rPMS plus rehabilitation
Sham rPMS plus rehabilitation
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Outcomes | Activities of daily living: Barthel Index (scores range from 0 to 100)
Upper limb function: Fugl‐Meyer Assessment (scores range from 0 to 66)
Spasticity: Modified Tardieu Scale of elbow and wrist (scores range from 0 to 5)
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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 |
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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 |