| Methods |
RCT
Method of randomisation: unclear
Blinding of outcome assessors: stated as 'yes'
Adverse events: 4 (2 in experimental group and 2 in control group)
Deaths: none stated
Dropouts: 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 11 in treatment group and 9 in control group completed the study 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' poststroke 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. not receiving 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 prevent participation in study |
| Interventions |
2 arms:
|
| Outcomes |
Outcomes were recorded at baseline and at postintervention, 3 months' postintervention
|
| Notes |
NCT00975156; same study as Kelley 2013
|
| 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 |
Authors state: "Blinded assessors tested the participants at baseline, post‐intervention, and 3‐month follow‐up." |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
1 participant in the control group was not analysed. |