Smania 2010.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: facility, Italy N = 64 Sample: recruited from the PD outpatient department of the G.B. Rossi University Hospital Neurological Rehabilitation (47% women) Age (years): mean (SD) intervention group 67.6 (7.4), control group 67.3 (7.2) Inclusion criteria: idiopathic PD; HY stage 3‐4; able to rise from chairs or beds without assistance; no other neurological conditions; sufficient cognition (Mini Mental State Examination score >23) Exclusion criteria: unstable cardiovascular disease or other chronic conditions that could interfere with their safety during testing or training procedures; severe dyskinesia or “on‐off” phases. Disease severity at baseline: HY stage 3 to 4, UPDRS total score mean (SD) 44.6 (14.2) |
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Interventions | Exercise 1. Exercise: balance exercises. Individual treatment supervised by a physiotherapist (50 minutes, 3x/week for 7 weeks) 2. Control: exercises not specifically aimed at improving postural reactions. Individual treatment supervised by a physiotherapist (50 minutes, 3x/week for 7 weeks) |
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Outcomes | 1. Rate of falls Other outcomes reported but not included in this review |
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Duration of the study | 3 months | |
Funding source | No funding | |
Notes | Fall data collected: during the 4‐week baseline period, the last 4‐week intervention period and the 4‐week follow‐up period by falls diaries | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of generating the randomisation list not described. Quote: "...according to a simple randomization scheme using a randomization list locked in a desk drawer accessible only to the principal investigator..." |
Allocation concealment (selection bias) | Unclear risk | Principal investigator’s role not described elsewhere. Quote: "…according to a simple randomization scheme using a randomization list locked in a desk drawer accessible only to the principal investigator.” |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and intervention (exercise) delivery personnel not blinded to group allocation but impact of non‐blinding unclear. |
Blinding of outcome assessment (detection bias) Falls and fallers | Unclear risk | Unclear if personnel collecting fall information blinded to group allocation. |
Incomplete outcome data (attrition bias) Falls | High risk | See appendix for method of assessment |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’ as unable to find a published protocol or trial registration. |
Method of ascertaining falls (recall bias) Falls and fallers | Low risk | The study used concurrent collection of data about falling with monthly, or more frequent, follow‐up by the researchers. Quote: “Each participant was requested to record any falls in a diary for 1 month prior to the start of each evaluation session.” |