Martin 2015.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: home, New Zealand N = 21 Sample: recruited from the New Zealand Brain Research Institute database (38% women) Age (years): mean (SD) Immediate start intervention group 72 (5.1) Delayed start intervention group 72 (5.8) Inclusion criteria: diagnosis of PD by a movement disorder specialist; aged over 65 years; presence of FOG as indicated by answering “yes” to question 1 on New Freezing of Gait Questionnaire (NFOGQ); independently mobile with or without walking aid; stable PD medication regimen at the time of recruitment Exclusion criteria: cognitive impairment (Mini Mental State Examination Score of <24); comorbidities that would prohibit safe participation in exercise; unable to press metronome buttons, or hear a metronome adequately Disease severity at baseline: HY stage mean (SD) 2.8 (0.6) |
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Interventions | Exercise 1. Exercise: immediate start (2 week wait period) ‐ Cued Up! program including home‐based cued exercises and practice of functional movements associated with freezing of gait (FOG) using cues along with strategies for preventing FOG (30‐60 min for 24 weeks ‐ including 6 home visits by a physiotherapist within the first 4 weeks of the 24‐week intervention period followed by weekly phone calls for the remaining 20 weeks) 2. Exercise: delayed start (24 week wait period) ‐ Cued Up! program including home‐based cued exercises and practice of functional movements associated with FOG using cues along with strategies for preventing FOG (30‐60 min. for 24 weeks ‐ including 6 home visits by a physiotherapist within the first 4 weeks of the 24‐ week intervention period followed by weekly phone calls for the remaining 20 weeks) |
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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 | 12 months | |
Funding source | Canterbury Multiple Sclerosis and Parkinson's Disease Society, Physiotherapy New Zealand's Older Adult and Neurology Special Interest Groups, and the Hope Foundation for Research on Ageing | |
Notes | Fall data collected: at baseline (weeks 1‐5), mid active (weeks 9‐13) and end of active (weeks 24‐28) 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: "Participants were randomized to immediate‐start (IS), n =1 2, or 6‐month delayed‐start (DS), n = 9, groups by a computerized random number generator.” |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement. |
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 | Low risk | Based on fall rates reported for weeks 24‐28. See appendix for method of assessment |
Incomplete outcome data (attrition bias) Fallers | Low 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: “Participants used a daily diary to record whether a fall had occurred and the number of falls that occurred each day. Family or care givers were also instructed on use of the falls diary to help with its completion. Participants posted diaries to the researcher each month. Telephone calls were made to prompt participants if diaries were not received.” |