Verrusio 2017.
| Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months |
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| Participants | Setting: Rome, Italy Number of participants: 150 Number analysed: 147 Number lost to follow‐up: 3 Sample: outpatients Age (years): mean 64.9 (SD 4.6) Sex: 53% female Inclusion criteria: young old people (60 – 69 years), normal or corrected vision, Tinetti score 19 ‐ 24 Exclusion criteria: medical condition that prevented safe participation in an exercise programme, peripheral artery occlusive disease, diabetic neuropathy, history of stroke, history of inflammatory arthritis, history of vertebral fragility fractures or hip or leg fractures or both in the previous 24 months, systolic blood pressure 200 mmHg or diastolic blood pressure 110 mmHg, or both |
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| Interventions | 1. Individual, supervised balance and gait training using exoskeleton human body posturiser: moderate intensity, 1 hour, 3 a week for 12 months 2. Individual supervised walking, balance and posture training: moderate intensity, 1 hour, 3 a week, for 12 months |
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| Outcomes | 1. Number of people who experienced 1 or more falls (risk of falling) | |
| Duration of the study | 52 weeks | |
| Adherence | Not reported | |
| Notes | Source of funding: not reported 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: "participants were randomly assigned into two groups following simple randomization procedures (computerized random numbers)" |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| 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 | Unclear risk | It is unclear whether the assessors recording falls were blinded to group allocation |
| 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 | Not applicable |
| Blinding of outcome assessment (detection bias) Health related quality of life (self report) | High risk | Participants were not blinded to group alloction |
| Incomplete outcome data (attrition bias) Falls and fallers | Low risk | Less than 20% of fall data are missing (2%). The missing data were balanced between the groups with 2 lost to follow‐up in the intervention group and 1 in the control group |
| Selective reporting (reporting bias) | High risk | Falls were measured, but number of falls was not reported |
| Method of ascertaining falls (recall bias) | Low risk | Quote: "The number of falls will be monitored with daily fall diaries. Diaries will be collected monthly through the mail. Details of each registered fall will be ascertained by the investigator" |