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

Zhu 2004

Methods RCT, parallel‐group design
Method of randomisation: random number table
Allocation concealment: unclear
Blinding of outcome assessors: no
Adverse events: not reported by the authors
Drop outs: none, all participants completed the study
ITT: yes
Participants Country: China
20 participants (10 in EXP group, 10 in CTL group)
Ambulatory at study onset: not stated by the authors
Mean age: 58 to 57 years (CTL and EXP group respectively)
Inclusion criteria: aged 30 to 80 years; ischaemic or haemorrhagic stroke; confirmed by CT or MRI; not able to walk (FAC of 2 or less); being able to stand up without help; MMSE ≥ 21 points
Exclusion criteria: other conditions than stroke affecting ambulation, such as history of spinal cord injury or amputation; myocardial infarction; severe heart failure; poor kidney function; uncontrolled diabetes mellitus; activated rheumatic diseases; MMSE < 21 points; body weight ≥ 110 kg
Interventions 2 arms, treated as inpatients:
  1. treadmill training with body weight support (EXP): participants walked on the Pneu‐weight system 5 sessions per week for 4 weeks (duration of sessions not stated), therapy (duration, body weight support) was tailored to the patients individual capabilities

  2. traditional gait training (CTL): conventional functional gait training 5 sessions per week for 4 weeks (duration of sessions not stated)

Outcomes Assessed at baseline and at the end of the intervention phase:
  • walking ability (FAC)

  • balance ability (BBS)


The following outcomes were measured by footprint analysis:
  • ipsilateral stepping length

  • contralateral stepping length

  • contralateral stride

  • ipsilateral stride

  • contralateral step angle

  • ipsilateral step angle

  • cadence

  • step width

  • walking speed

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number table
Allocation concealment (selection bias) Unclear risk Not described
Blinding of outcome assessment (detection bias) All outcomes High risk Outcome assessor was not blinded

ADL: activities of daily living BBS: Berg Balance Scale BWS: body weight support BWSTT: body weight supported treadmill training CT: computed tomography CTL: control EMG: electromyographic activity EXP: experimental FAC: Functional Ambulation Category FIM: Functional Independence Measure FMA: Fugl‐Meyer Assessment ITT: intention‐to‐treat km/hr: kilometres per hour LTT: limited progressive treadmill training m/min: metre per minute m/s: metre per second MMSE: Mini Mental State Examination MRI: magnetic resonance imaging NYHA: New York Heart Association RCT: randomised controlled trial RMAS: Rivermead Motor Assessment Scale RMI: Rivermead Mobility Index SD: standard deviation STT: speed‐dependent treadmill training TBC: to be confirmed TTBWS: treadmill training with body weight support