Skip to main content
. 2017 May 10;2017(5):CD006185. doi: 10.1002/14651858.CD006185.pub4

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
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
Interventions 2 arms:
  • Experimental group: electromechanical gait training (20 minutes) and conventional physiotherapy including stance/gait (25 minutes) 6 days a week for 8 weeks (45 minutes per day)

  • Control group: conventional physiotherapy (including therapy to improve stance/gait), same time and frequency as experimental group

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)
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."