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. 2014 Jan 23;2014(1):CD002840. doi: 10.1002/14651858.CD002840.pub3

Visintin 1998

Methods Parallel‐group design Participants randomised to groups using a stratified block randomisation scheme Allocation was concealed using sealed and numbered envelopes 21% drop outs at the end of the treatment phase, 48% drop outs at the 3‐month follow‐up Blinding of outcome assessors to group allocation
Participants 50 participants in the EXP group and 50 participants in the CTL group Inclusion criteria: admitted to the Jewish Rehabilitation Hospital for physical rehabilitation after stroke; abnormal gait; no severe cardiac problems; no comorbid conditions contraindicating treadmill training; not cerebellar, bilateral or brain stem stroke; able to understand simple commands; anticipated length of stay of at least 4 weeks; onset of stroke no more than 6 months prior to recruitment; able to ambulate pre‐stroke; first admission during study period; treadmill training time slot available; informed consent
Interventions Treated as inpatients for 4 x 20‐minute session per week for 6 weeks Treadmill training with body weight support (EXP): participants walked on a treadmill with partial body weight support using a harness and the assistance of 1 to 2 therapists Treadmill training only (CTL): participants walked on a treadmill with the assistance of 1 to 2 therapists; no body weight support was provided using a harness
Outcomes Assessed at baseline, after treatment phase and 3 months later:
  • preferred walking speed over 3 m (personal assistance and gait aids could be used)

  • walking endurance ‐ maximum distance walked up to a maximum of 320 m (personal assistance and gait aids could be used)

  • Berg Balance Scale

  • Stroke Rehabilitation Assessment of Movement

Notes The rating of concealed allocation and the allocation concealment classification were changed based on correspondence from the trialist Data divided into 2 comparisons, see Visintin 1998a and Visintin 1998b
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Drawing lots out of a box
Allocation concealment (selection bias) Low risk Allocation was concealed using sealed and numbered envelopes
Blinding of outcome assessment (detection bias) All outcomes Low risk Outcome assessors were blind to group allocation