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:
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:
|
|
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 |