Wong‐Yu 2015.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: facility and home, Hong Kong N = 70 Sample: recruited from the Hong Kong PD Association (a patient self‐help group) and movement disorder clinics (43% women) Age (years): mean (SD) intervention group 60.2 (9), control group 61.9 (8.5) Inclusion criteria: diagnosis of PD according to the United Kingdom PD Brain Bank Criteria; at least 30 years of age; stable on anti‐PD medications; no fall history in the previous 6 months; could walk 30mutes with or without a cane Exclusion criteria: musculoskeletal or cardiopulmonary disorders; had undergone neurosurgery; neurologic conditions other than PD; cognitive deficits on the Mini‐mental State Examination (<24); had joined another exercise program in the previous 3 months. Disease severity at baseline: HY stage mean (SD) 2.4 (0.3), MDS‐UPDRS motor score mean (SD) 29.7 (10.6) |
|
Interventions | Exercise 1. Exercise: task‐ and context‐specific multisystem balance program and lower limb strength training. Group supervised by a physiotherapist and an assistant (120 minutes, 1x/week for 8 weeks). Plus, home exercise guided by handouts and DVDs (3 hours/week) 2. Control: upper limb training. Group supervised by a physiotherapist and an assistant (120 minutes, 1x/week for 8 weeks). Plus, home exercise guided by handouts and DVDs (3 hours/week) |
|
Outcomes | 1. Rate of falls 2. Number of fallers Other outcomes reported but not included in this review |
|
Duration of the study | 8 months | |
Funding source | Hong Kong Parkinson's Disease Foundation (no. 8‐ZH89). | |
Notes | Fall data collected: at 1‐week pre‐training, immediately post‐training and at the 6‐month post‐training follow‐up by fall 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: "Before the baseline assessment, a team member not involved in this study used the Research Randomizer to make a randomized assignment of eligible participants into either a balance (BAL) or an active control (CON) group.” |
Allocation concealment (selection bias) | Low risk | Allocation concealment was described as by central allocation. Quote: "Before the baseline assessment, a team member not involved in this study used the Research Randomizer to make a randomized assignment of eligible participants into either a balance (BAL) or an active control (CON) group.” |
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 | See appendix for method of assessment |
Incomplete outcome data (attrition bias) Fallers | Low risk | See appendix for method of assessment |
Selective reporting (reporting bias) | High risk | The study protocol is available (NCT01799681) and pre‐specified outcomes of interest (falls and fallers) were specified to be reported over 12 months, but have been reported over 6 months. A pre‐specified secondary outcome of interest (PDQ‐39) has not been reported. |
Method of ascertaining falls (recall bias) Falls and fallers | Unclear risk | The study used concurrent collection of data about falling however it is unclear if there was any follow‐up by the researchers. Quote: “Fall diaries were provided, and subjects were instructed to complete a standard form on the date and location of the fall, fall activities, landing body parts, perceived causes, and related injuries, as soon as possible after each fall event.” |
CNS: central nervous system; DSM IV: Diagnostic and Statistical Manual of Mental Disorders, fourth edition;HY stage: Hoehn and Yahr Stage; MDS‐UPDRS: Movement Disorders Society Sponsored Revision of the Unified Parkinson's disease Rating Scale;PD: Parkinson's disease; RCT: randomised controlled trial; QALY: quality‐adjusted life years: SF36: Short Form 36; SD: standard deviation; UPDRS: Unified Parkinson's Disease Rating Scale;