Gurak 2005.
Methods | Parallel randomised trial Method of randomisation: simple randomisation Method of concealment: unclear Blinding: unclear Analysis: unclear | |
Participants | Location: Russia
Setting: outpatient clinic Number of participants: 30 at randomisation and all completed the study (33% male, mean age 51 years) Treatment group: 15 Control group: 15 Stroke criteria: ischaemic, criteria unclear Time since stroke onset at randomisation: > 3 months after stroke Fatigue criteria: MFI‐20 Other entry criteria: unclear Comparability of groups: unclear |
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Interventions | Treatment intervention: enerion (a synthetic derivative of vitamin B1, 200 mg, twice per day, 30 days) plus standard rehabilitation Control intervention: standard rehabilitation Treatment duration: 30 days Delivered by: unclear |
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Outcomes | Time for fatigue assessment: baseline and at the end of 30‐day treatment Primary outcome: MFI‐20 (general fatigue, physical fatigue, low activity, low motivation and mental fatigue) |
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Notes | Only people with PSF (MFI‐20) were recruited Funding: no information available |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | High risk | Interventions used in the 2 groups were visibly different, so participants and medical staff would be aware of what was being used |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not enough information reported |
Intention‐to‐treat | Low risk | No loss to follow‐up reported |