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. 2015 Feb 12;2015(2):CD008349. doi: 10.1002/14651858.CD008349.pub3

Mirelman 2008

Methods RCT
Participants Study took place in New Jersey, USA
18 participants: 9 intervention, 9 control
Inclusion criteria: chronic hemiparesis after stroke with residual gait deficits, partial antigravity dorsiflexion, able to walk 50 feet without the assistance of another person, sufficient communication and cognitive ability to participate
Exclusion criteria: motion sickness and receiving concurrent therapy
Mean (SD) age: intervention group 62 (10) years, control group 61 (8) years
83% male
Stroke details: 44% right hemiparesis
Timing post stroke: intervention group mean (SD) 38 (25) months, control group 58 (26) months
Interventions Virtual reality intervention: Rutgers ankle rehabilitation system (a 6 degree of freedom platform force‐feedback system) that allows participants to exercise the lower extremity by navigating through a virtual environment displayed on a desktop computer. Participants executed the exercises by using the foot movements to navigate a plane or a boat through a virtual environment that consisted of a series of targets
Control intervention: Rutgers ankle rehabilitation system without the virtual environment. Participants were instructed by the therapist on which direction to move their foot and were paced by a metronome cueing them to complete a comparable number of repetitions
Sessions were 60 minutes, 3 times a week for 4 weeks (12 hours total)
Outcomes Outcomes recorded at baseline, post‐intervention and at 3 months
Lower limb function and activity outcomes: gait speed over 7‐metre walkway, 6‐minute walk test, Patient Activity Monitor (distance walked, number of steps per day, average speed, step length, top speed)
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was performed based on the table of numbers method (generated by a computer)
Allocation concealment (selection bias) Low risk Allocation was done by an external person to the project and held in a database spreadsheet on a computer in his office which was password protected
Blinding of outcome assessment (detection bias) All outcomes Low risk Blind
Incomplete outcome data (attrition bias) All outcomes Low risk 1 participant in the robotic‐virtual reality group was lost to follow‐up because of personal reasons. 1 outlier was identified in the robotic‐virtual reality group following the descriptive analysis of the endurance test (6MWT), the values presented for this individual were 2 SD from the mean therefore he was excluded from the analysis
Selective reporting (reporting bias) Low risk No other outcomes were collected