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. 2014 Jan 23;2014(1):CD002840. doi: 10.1002/14651858.CD002840.pub3

Smith 2008

Methods RCT Method of randomisation: modified random assignment, matched‐pair CTL group design; stratified regarding (1) motor impairment (measured by FMA) and (2) side of hemiparesis Blinding of outcome assessors: no Adverse events: not reported Deaths: not reported Drop outs: not reported ITT: unclear
Participants Country: USA 20 participants (10 in EXP group, 10 in CTL group) Ambulatory at study onset: yes Mean age: 56 to 58 years (CTL and EXP group respectively) Inclusion criteria: informed consent, ischaemic stroke in the distribution of the middle cerebral artery < 3 months, but > 2 years prior to study enrolment, walking slower than prior to the stroke Exclusion criteria: cognitive impairment, inability to ambulate, concomitant pathology interfering with treadmill walking
Interventions 2 arms:
  1. CTL group received weekly telephone calls, asking about the quality of the participant’s week and encouraging them to record life events in a log

  2. EXP group additionally received treadmill training 12 times per month (mean intensity: 1 hour per week)

Outcomes Outcomes were recorded at baseline, at the end of the intervention phase and at 6‐week follow‐up Outcomes: depression (Beck Depression Inventory); Stroke Impact Scale (SIS)
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding of outcome assessment (detection bias) All outcomes High risk Outcome assessor was not blinded