Tong 2006.
| Methods | RCT Randomisation was done by computer‐generated random numbers Blinding of outcome assessors: no (except for Barthel Index and Functional Independence Measure scores, which were performed by nurses who were blinded) Adverse events: 2 (none in experimental group, 2 in control group) Deaths: none Dropouts: 4 (none in experimental group, 4 in control group) ITT: yes | |
| Participants | Country: Hong Kong, China 50 participants (15 in treatment group A, 15 in treatment group B, 20 in control group) Non‐ambulatory at study onset Mean age: 68 years Inclusion criteria: diagnosis of first ischaemic brain injury or intracerebral haemorrhage shown by magnetic resonance imaging or computed tomography less than 6 weeks after onset of stroke; sufficient cognition to follow simple instructions and understand the content and purpose of the study (MMSE score > 21); ability to stand upright, supported or unsupported, for 1 minute; significant gait deficit (FAC score < 3); no skin allergy to electrical stimulation Exclusion criteria: recurrent stroke; other neurological, medical, or psychological deficit or condition that would affect ambulation ability or compliance with study protocol (such as Parkinson's disease, major depression, pain, cardiac arrhythmias); aphasia with an inability to follow 2 consecutive step commands or a cognitive deficit; severe hip, knee, or ankle contracture that would preclude passive range of motion of the leg | |
| Interventions | 3 arms:
The study consisted of 1 training session per weekday for 4 weeks. Experimental groups 1 and 2 underwent gait training for 20 minutes, with body weight support by an electromechanical gait trainer; group 2 also received functional electrical stimulation to the paretic lower limb during gait training. Participants in group 3 received physiotherapy overground gait training based on the principles of proprioceptive neuromuscular facilitation and Bobath concepts. |
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| Outcomes |
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| Notes | Published and unpublished data provided by the authors. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
| Allocation concealment (selection bias) | Low risk | Concealed |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Yes for primary outcome |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | ITT unclear |