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

Thaut 2019.

Study characteristics
Methods RCT
Participants Setting: home, USA
N = 60
Sample: study participants were randomly selected from referral lists of local Parkinson's disease support groups and neurology practices (62% women)
Age (years): Mean (SD) intervention group 71 (7), control group 73 (8)
Inclusion criteria: diagnosis of idiopathic PD; HY stage 3 or 4; at least two falls in the past year; a stable antiparkinson medication regime; able to walk independently at least 50 metres.
Exclusion criteria: other neurological or orthopaedic conditions; medically diagnosed hearing loss; dementia (Mini‐mental State Examination score of < 24)
Disease severity at baseline: HY stage mean 3.5 (SD not reported)
Interventions Exercise
1. Exercise: walking in a home‐based environment with rhythmic auditory stimulation via click‐embedded music. Individual, level of supervision unclear (30 minutes, 7x/week for 24 weeks)
2. Exercise: walking in a home‐based environment with rhythmic auditory stimulation via click‐embedded music. Individual, level of supervision unclear (30 minutes, 7x/week for 16 weeks; 8 weeks intervention, 8 weeks no intervention, 8 weeks intervention)
All participants received standard care and optimal medical treatment during the study
Outcomes 1. Number of fallers
Duration of the study 24 weeks
Funding source The Charlene B. Flood Memorial Fund, San Diego California
Notes Fall data collected: during the 24 week intervention period, details of ascertainment not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A random component in the sequence generation was described.
Quote: "Subjects were randomly selected and assigned in an intent‐to‐treat design to the experimental and control conditions using a computerized random selector program."
Allocation concealment (selection bias) Low risk Allocation concealment was described as by central allocation.
Quote: "Subjects were randomly selected and assigned in an intent‐to‐treat design to the experimental and control conditions using a computerized random selector program implemented by a computer specialist external to the study to assure allocation concealment."
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.
Quote: "The Fall Index was computed based on self‐reports by subjects or caregivers”
Incomplete outcome data (attrition bias)
Falls Unclear risk Data not available to assess.
Incomplete outcome data (attrition bias)
Fallers Unclear risk Data not available to assess.
Selective reporting (reporting bias) Low risk The study protocol is available (NCT03316365) and all of the study’s pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way.
Method of ascertaining falls (recall bias)
Falls and fallers Unclear risk Details of ascertainment are not described.