Ada 2013
| Methods | RCT Method of randomisation: computer‐generated Blinding of outcome assessors: stated as 'yes' by the investigator Adverse events: not stated Deaths: none Drop outs: 4 (0 in EXP group A, 1 in EXP group B, 3 in CTL group) ITT: yes | |
| Participants | Country: Australia 102 participants (34 in EXP group A, 34 in EXP group B, 34 in CTL group) Ambulatory at study onset Mean age: 63 years; 64 to 70 years (control and EXP groups respectively) Inclusion criteria: within 5 years of their first stroke, adults capable of providing consent (defined as having a MMSE score of > 23), had been discharged from formal rehabilitation, were community dwelling and walked slowly (defined as being able to walk 10 metres across flat ground in bare feet without any aids taking more than 9 seconds) Exclusion criteria: unstable cardiac status precluding them from participation in a treadmill training programme (i.e. permission not granted by their medical practitioner), or had severe cognitive and/or language deficits (aphasia) precluding them from participation in the training sessions (i.e. unable to follow 2‐step commands) | |
| Interventions | 3 arms: EXP group A undertook 30 minutes of treadmill and overground walking 3 times per week for 4 months EXP group B undertook treadmill training for 2 months CTL group had no intervention |
|
| Outcomes | Outcomes were recorded at baseline and after 2, 4, 6 and 12 months
|
|
| Notes | The AMBULATE trial We combined the results of both treadmill groups (EXP group A and EXP group B) as 1 group and compared with the results of the CTL group |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated, independent and concealed randomisation was used to assign each participant in this study |
| Allocation concealment (selection bias) | Low risk | Independent and concealed allocation was used |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome measures were collected by therapists trained in the measurement procedures who were blind to group allocation |