Park 2011
Methods | Design: randomised, single‐blind trial of cardiorespiratory training plus usual care versus usual care ‐ during usual care Randomisation mechanism: participants blindly pick 1 of 2 cards Allocation concealment: envelopes used Blinding: outcome assessor blind to group allocation ITT: not reported Measurements: end of intervention (4 weeks) Withdrawals: 2 participants (1 from both intervention and control groups) not regularly participating |
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Participants | Randomised: 27 participants Intervention: 14 participants; 7 males and 6 females; mean age 59.4 years (SD 8.5) Control: 13 participants; 5 males and 7 females; mean age 56.9 years (SD 7.8) Inclusion criteria: 6 months to 5 years post first stroke; walking speed < 0.7 m/s Exclusion criteria: auditory or visual deficits; no orthopaedic or cardiovascular conditions; cognitive impairment (> 25 MMSE score) |
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Interventions | Invention group: 4‐phased walking training programme (progressing 150 metres to 200 metres to 300 metres to 500 metres) 1 hour 3 times/week for 4 weeks Control group: usual physiotherapy care 1 hour daily based on Bobath concept Setting: community based |
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Outcomes | Included outcomes: 10 metre Walk Test; 6‐MWT; Community Walk test Other outcomes: walking ability questionnaire; activities‐specific balance confidence scale |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants drew 1 of 2 cards from an envelope |
Allocation concealment (selection bias) | Unclear risk | Envelopes used; nature of concealment unclear |
Blinding (performance bias and detection bias) All outcomes | High risk | No attention control |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Person assessing outcome and analysing data blinded |
Incomplete outcome data (attrition bias) End of intervention | Low risk | ITT analysis not reported 2/27 (7%) lost at the end of intervention: 1 from intervention and 1 from control groups (not regularly participating) |
Selective reporting (reporting bias) | Unclear risk | No protocol available |
Other bias | Unclear risk | Unclear |
Imbalanced exposure | High risk | Imbalanced exposure |