Sedaghati 2016.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: facility, Iran N = 47 Sample: recruited from university afÂÂfiliated neurology clinics and private neurology offices in Kashan (30% women) Age (years): mean (SD) progressive balance and gait training with balance pad intervention group 59.1 (8.4), progressive balance and gait training without balance pad intervention group 58.8 (8.1), control group 57.2 (6.9) Inclusion criteria: diagnosis of idiopathic PD for three years; able to walk independently; aged between 50 and 70 years; consumed the same anti‐PD medication for past 2 weeks; history of falling in the past year Exclusion criteria: significant cognitive impairment (Mini Mental State Examination < 24); other neurological/musculoskeletal/ cardiopulmonary/metabolic conditions that would interfere with safe conduction of training or exercise program. Disease severity at baseline: HY stage 2 to 3, mean (SD) 2.6 (0.5) |
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Interventions | Exercise 1. Exercise: progressive balance and gait training activities with balance pad. Wholly‐supervised exercises (60 minutes, 3x/week for 10 weeks) 2. Exercise: progressive balance and gait training activities with no balance pad. Wholly‐supervised exercises (60 minutes, 3x/week for 10 weeks) 3. Control: received their usual care by a neurologist |
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Outcomes | 1. Rate of falls Other outcomes reported but not included in this review |
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Duration of the study | 10 weeks | |
Funding source | Not reported | |
Notes | Fall data collected: at baseline and after a 10‐week follow‐up intervention by direct questioning | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of generating randomisation list not described. Quote: "After baseline assessment, participants were randomly allocated to control and two exercise groups.” |
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 | See appendix for method of assessment |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement as unable to find a published protocol or trial registration. The published trial registration number appears to be incorrect. |
Method of ascertaining falls (recall bias) Falls and fallers | Unclear risk | No information about how or when this direct questioning occurred. Quote: “The number of falls were recorded by direct questioning.” |