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) |
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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 |
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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. |