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

Richards 1993

Methods Parallel‐group design Participants randomised to groups using a stratified block randomisation scheme Concealed allocation to groups not reported 15% drop outs at the end of the treatment phase, number of drop outs not reported at 3 and 6‐month follow‐ups Blinding of outcome assessors to group allocation
Participants 10 participants in the EXP group, 8 participants in the CTL 1 group and 9 participants in the CTL 2 group
Non‐ambulatory at study onset Inclusion criteria: resident within 50 km of Quebec; aged 40 to 80 years; less than 7 days after onset of first stroke; clinically identifiable middle cerebral artery syndrome of thromboembolic origin involving sub‐cortical structures confirmed by CT; under medical supervision of study neurologists; informed consent; middle‐band disability according to Garraway (i.e. excluded patients independent in ambulation as well as those who were unconscious) Exclusion criteria: other neurological problems; major medical problems that would incapacitate functional capacity (patients independent in ambulation were excluded)
Interventions Treated as inpatients for 6 weeks for a mean of 1.74 (SD 0.15) (EXP), 1.79 (SD 0.10) (CTL 1) and 0.72 (SD 0.10) (CTL 2) hours per day Early intensive task‐oriented physiotherapy (EXP): treatment started as early as possible after stroke and included treadmill training (no body weight support was provided using a harness), tilt table exercises and resisted exercises using isokinetic equipment Early intensive traditional physiotherapy (CTL 1): treatment started as early as possible after stroke and included traditional physiotherapy based on neurophysiological techniques Delayed non‐intensive traditional physiotherapy (CTL 2): treatment started later after stroke and included less intense traditional physiotherapy based on neurophysiological techniques
Outcomes Assessed at baseline, after treatment phase and 3 and 6 months later:
  • walking speed over 4 metres (personal assistance could be used, but speed of test (preferred or fast), supervision and gait aid use not reported)

  • 15‐item Barthel Index

  • FMA

  • Berg Balance Scale

Notes 3 and 6‐month follow‐up data not reported We chose to compare the EXP and CTL 1 groups only for this review because they had the same intensity and starting time of therapy
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Evaluators were blind to group allocation