Song 2018.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: home, Australia N = 60 Sample: recruited from metropolitan Sydney, via Parkinson’s disease support groups and neurology clinics (60% women) Age (years): mean (SD) intervention group 68 (7), control group 65 (7) Inclusion criteria: diagnosis of idiopathic PD; living in the community; age 40 years or older; ability to walk unaided for at least 30 metres; stable antiparkinsonian medication for at least 2 weeks Exclusion criteria: cognitive impairment (Mini‐mental State Examination score of < 24); medical conditions which would preclude or interfere with physical assessment or stepping training Disease severity at baseline: MDS‐UPDRS motor score mean (SD) 32 (12) |
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Interventions | Exercise 1. Exercise: home‐based stepping training exercise video game (at least 15 minutes, 3x/week for 12 weeks ‐ including 3 sessions supervised by a therapist, with two of these supervised sessions at the beginning and one in the middle of the intervention period), plus usual activities and health care 2. Control: maintain usual activities and healthcare |
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Outcomes | 1. Rate of falls 2. Number of fallers Other outcomes reported but not included in this review |
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Duration of the study | 6 months | |
Funding source | Parkinson's New South Wales Bendigo Bank Parkinson's Research Grant and a University of Sydney Bridging Support Grant | |
Notes | Fall data collected: during the 6‐month intervention period by monthly falls diaries | |
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: "The random allocation was conducted using a computer‐generated table with randomly permuted blocks..." |
Allocation concealment (selection bias) | Low risk | Allocation concealment was described as by central allocation. Quote: “The trial manager emailed the allocating researcher, who was located offsite and was not involved in recruitment, intervention or outcome assessment." |
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 were blinded to group allocation. |
Incomplete outcome data (attrition bias) Falls | Low risk | See appendix for method of assessment |
Incomplete outcome data (attrition bias) Fallers | Low risk | See appendix for method of assessment |
Selective reporting (reporting bias) | Low risk | The study protocol is available (ACTRN12613000688785) 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 | Low risk | The study used concurrent collection of data about falling with monthly, or more frequent, follow‐up by the researchers. |