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

MacKay‐Lyons 2013

Methods RCT
Method of randomisation: computer‐generated, blocked randomisation Blinding of outcome assessors: stated as 'yes' by the investigator Adverse events: not stated Deaths: not stated Drop outs: 5 (2 in EXP group, 3 in CTL group) ITT: all analyses were conducted on an ITT basis (that means carrying the last observation forward for those lost to follow‐up)
Participants Country: Canada 50 participants (24 in EXP group, 26 in CTL group) Ambulatory at study onset Mean age: 59 to 62 years (control and EXP group respectively) Inclusion criteria: men and women older than 18 years, within 1 month of a first ischaemic stroke confirmed by neuroimaging, inpatients in the stroke rehabilitation unit and able to walk 5 metres with or without use of ambulatory aids, ankle orthoses or stand‐by assistance
Exclusion criteria: contraindications to maximal exercise stress testing, musculoskeletal or cognitive limitations that could preclude participation in the programme, or involvement in other pharmacological or physical intervention studies
Interventions 2 arms:
  1. body weight supported treadmill training + usual care

  2. usual care


All individuals participated in 60‐minute physiotherapy sessions 5 times weekly as inpatients for 6 weeks and 3 times weekly as outpatients for another 6 weeks for a total of 48 sessions Substitute sessions for missed appointments were provided
Outcomes Assessments were done at baseline, post‐training, at 6 and 12‐month follow‐up:
  • peak oxygen consumption, VO2peak

  • walking ability (6‐Minute Walk Test and 10‐metre walk)

  • Berg Balance Scale

  • motor impairment (Chedoke‐McMaster Stages of Recovery, Leg and Foot)

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated, blocked randomisation
Allocation concealment (selection bias) Low risk A person not involved in the study prepared and safeguarded individual, opaque sealed envelopes containing group and physiotherapist allocation, which were opened after completion of the baseline assessment
Blinding of outcome assessment (detection bias) All outcomes Low risk All outcome assessments were conducted by a blinded assessor located off‐site