Noser 2012
| Methods | RCT Method of randomisation: unclear Blinding of outcome assessors: stated as 'yes' Adverse events: 4 (2 in experimental and 2 in control group) Deaths: none stated Drop‐outs: 1 in the control group (protocol violation) ITT: stated as 'yes' | |
| Participants | Country: USA 21 participants (11 in treatment group, 10 in control group), 20 participants completed all training sessions and were analysed as per protocol All participants were ambulatory at start of study Mean age: unclear Inclusion criteria: people with ischaemic or haemorrhagic stroke confirmed by cerebral CT or MRI scan, age > 18, at least 3 months post‐stroke at time of enrolment into study, ability to walk at least 10 feet with maximum 1 person assist, but not to walk in the community independently; residual paresis in the lower extremity as defined by NIHSS lower extremity motor score 2 to 4, ability to perform Lokomat ambulation training with assistance of 1 therapist, ability to follow a 3‐step command, physician approval for patient participation, ability to give informed consent, completed rehabilitation services (i.e. receiving no concurrent physical, occupational or speech therapy) Exclusion criteria: serious cardiac condition, uncontrolled blood pressure defined as > 200 or diastolic > 100 at rest, history of serious chronic obstructive pulmonary disease or oxygen dependence, severe weight‐bearing pain, lower extremity amputation, claudication while walking, life expectancy < 1 year, history of deep vein thrombosis or pulmonary embolism within 6 months, severe orthopaedic problem, any medical or psychiatric condition that the investigators believe would make the patient unable to participate in this study | |
| Interventions | 2 arms:
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| Outcomes | Outcomes were recorded at baseline and at post‐intervention, 3 months post‐Intervention
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| Notes | NCT00975156 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement | 
| Random sequence generation (selection bias) | Unclear risk | Unclear | 
| Allocation concealment (selection bias) | Unclear risk | Unclear | 
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Yes | 
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear if reasons for missing outcome data are unlikely to be related to true outcome |