Mirelman 2016.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 6 months |
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Participants | Setting: Belgium, Israel, Italy, the Netherlands, and the UK Number of participants: 152 Number analysed: no fall data Sample: community‐dwelling Age (years): mean 82.6 Sex: 35% female Inclusion criteria: aged 60 − 90 years, able to walk ≥ 5 minutes unassisted, stable medication for the past month, self‐reported ≥ 2 falls within 6 months before screening; individuals with mild cognitive impairment were included if they had a score of 0·5 on the Clinical Dementia Rating scale Exclusion criteria: psychiatric comorbidity (e.g. major depressive disorder in accordance with DSM IV criteria); history of stroke, traumatic brain injury, or other neurological disorders (other than Parkinson’s disease and mild cognitive impairment, for those groups); acute lower back or lower extremity pain; peripheral neuropathy; rheumatic and orthopaedic diseases; or a clinical diagnosis of dementia or severe cognitive impairment (MMSE score < 21) |
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Interventions | 1. Individual, supervised treadmill training: progressed with treadmill duration and speed; 45‐minute session, 3 a week for 6 weeks 2. Individual, supervised treadmill training plus virtual reality: as (1) plus received projected images of the virtual environment (e.g. obstacles, distractors) that necessitated continual adjustment of steps; 45‐minute session, 3 a week for 6 weeks |
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Outcomes | 1. Health‐related quality of life | |
Duration of the study | 26 weeks | |
Adherence | Adherence measured by number of completed sessions of the 18 sessions: 1. Individual, supervised treadmill training: 16·82 (SD 1·81) 2. Individual, supervised treadmill training plus virtual reality: 16·62 (SD 1·78) |
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Notes | At baseline 130 participants had Parkinson's disease, 43 mild cognitive impairment, 109 idiopathic falls. Falls data unavailable only for non‐Parkinson's disease participants Source of funding: European Commission Economic information: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "By use of computer‐based allocation, participants were randomly assigned" |
Allocation concealment (selection bias) | Low risk | Group allocation performed by a third party not involved in the day‐to‐day running of the study; treating therapist notified by e‐mail to ensure concealed allocation |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel unblinded but impact of unblinding unknown |
Blinding of outcome assessment (detection bias) Falls | Low risk | Falls recorded using same method in each group Quote: "Falls were recorded without knowledge of training group" |
Blinding of outcome assessment (detection bias) Fractures | Unclear risk | Not applicable |
Blinding of outcome assessment (detection bias) Hospital admission, medical attention and adverse events | Unclear risk | The method of recording adverse events was unclear |
Blinding of outcome assessment (detection bias) Health related quality of life (self report) | High risk | Participants unblinded to intervention group |
Incomplete outcome data (attrition bias) Falls and fallers | Low risk | Less than 20% had missing data (7%) for the study. Missing data were balanced between the treadmill training group (n = 12) and treadmill plus virtual reality group (n = 8), with reasons for missing data similar between groups (e.g. 2 adverse events in treadmill group, 3 adverse events in virtual reality group) |
Selective reporting (reporting bias) | High risk | Falls measured, but number of fallers is not presented |
Method of ascertaining falls (recall bias) | Low risk | Participants received a falls calendar, which they were provided as a paper version, web‐based calender, or a smartphone application. Research staff contacted all participants every month to maximise compliance |