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. 2022 Jun 6;2022(6):CD011574. doi: 10.1002/14651858.CD011574.pub2

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)
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)
Outcomes 1. Rate of falls
Other outcomes reported but not included in this review
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.”