Chua 2016.
| Methods | RCT
Method of randomisation: computer‐generated sequence
Blinding of outcome assessors: stated as 'yes' by the investigator
Adverse events: no
Deaths: yes
Dropouts: yes (7 in treatment group, 13 in control group) ITT: yes |
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| Participants | Country: Singapore
108 participants (53 in treatment group, 53 in control group)
Not ambulatory at start of study
Mean age: 62 years experimental and 61 years control group Inclusion criteria: unilateral haemorrhagic/ischaemic stroke, age between 18 and 80 years, independent ambulation pre‐stroke Exclusion criteria: > 8 weeks poststroke, FAC ≥ 4, cardiovascular instability, MMSE < 16, communication deficits, lower limb joint contractures |
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| Interventions | 2 arms:
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| Outcomes | Outcomes were recorded at baseline and 4, 8, 12, 24, and 48 weeks after baseline Outcome measures: walking ability (FAC), Barthel Index, gait velocity (10‐metre walk test), gait endurance (6‐minute walk test), health status (Stroke Impact Scale) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Authors state: "Randomization was performed using a computer‐generated sequence of random numbers." |
| Allocation concealment (selection bias) | Low risk | Authors state: "An independent department generated the random group allocation sequence and transferred the sequence to a series of serially numbered opaque envelopes, which were not opened and revealed until after acceptance into the study and the baseline tests, therefore ensuring allocation concealment." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Authors state: "The data assessors were blinded to group allocation, but it was not possible to blind participants or the health care professionals providing interventions." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All data for all participants provided and analysed. Authors state: "An intention‐to‐treat approach was used. Data from subjects were analysed according to the group to which they were randomised, regardless of whether they completed the intervention. Participants failing to complete either intervention were asked to return for follow‐up." |