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

Werner 2002a

Methods Cross‐over group design Participants randomised to groups (group allocation in envelopes that were drawn by an independent person) 0% drop outs at the end of the first treatment phase Blinding of outcome assessors to group allocation
Participants 15 participants allocated to the EXP then CTL order, and 15 participants allocated to the CTL then EXP order Inclusion criteria: first stroke; supratentorial lesion; 4 to 12 weeks post stroke; aged less than 75 years; not able to walk (FAC of 2 or less); able to sit unsupported on the edge of a bed; able to stand for at least 10 seconds with help; written informed consent Exclusion criteria: hip and knee extension deficit of more than 20 degrees; passive dorsiflexion of the affected ankle to less than a neutral position; severe impairment of cognition or communication; evidence of cardiac ischaemia, arrhythmia, decompression or heart failure; feeling of 'overexertion' or heart rate exceeding the age‐predicted maximum (i.e. 190 beats/minute minus age) during training; resting systolic blood pressure exceeding 200 mmHg at rest or dropping by more than 10 mmHg with increasing workload
Interventions Treated as inpatients for 5 x 15 to 20‐minute sessions per week for 2 weeks
  1. Treadmill training with body weight support (EXP): participants walked on a treadmill with partial body weight support provided by a harness

  2. GaitTrainer with body weight support (CTL): participants walked on a GaitTrainer with partial body weight support provided by a harness

Outcomes This was an A‐B‐A (or B‐A‐B) design, so participants were assessed at baseline, at first cross‐over (2 weeks), at second cross‐over (4 weeks) and after treatment phase (6 weeks):
  • FAC

  • fast walking speed over 10 m with personal assistance and gait aids, if required

  • RMAS

  • ankle spasticity (modified Ashworth Scale)

Notes The number of drop outs was changed based on correspondence with the trialists
Trial treated as a parallel‐group design for this review by using the first treatment phase data only (that is baseline and first cross‐over data only)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Lots with sealed opaque envelopes that were drawn by an independent person
Allocation concealment (selection bias) Low risk Sealed opaque envelopes that were drawn by an independent person
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Outcome assessors were blinded to group assignment