Volpe 2014b.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: facility, Italy N = 34 Sample: did not describe the source of patients Age (years): mean (SD) intervention group 68 (7) control group 66 (8) Inclusion criteria: diagnosis of ‘clinically probable’ idiopathic Parkinson’s disease; HY stage 2.5 and 3; ability to walk without any assistance; at least two falls in the last year; Mini‐mental State Examination score ≥ 25; no relevant comorbidity or vestibular/ visual dysfunctions, limiting locomotion or balance; stable dopaminergic therapy in the last four weeks Exclusion criteria: history of deep brain stimulation surgery and other conditions limiting hydrotherapy (for example cardio pulmonary disease). Disease severity at baseline: HY stage 2.5 to 3, UPDRS motor score mean (SD) 40.6 (10.8) |
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Interventions | Exercise 1. Exercise: hydrotherapy focused on perturbation‐based balance training (60 minutes, 5x/week for 8 weeks) 2. Control: land‐based treatment focused on perturbation‐based balance training (60 minutes, 5x/week for 8 weeks) |
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Outcomes | 1. Rate of falls 2. Number reporting a fall‐related fracture 3. Quality of life (PDQ‐39) Other outcomes reported but not included in this review |
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Duration of the study | 10 weeks | |
Funding source | No funding | |
Notes | Fall data collected: Falls which occurred two months prior to the trial and during the 2 month trial period were collected by falls diary or telephone interview | |
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: "For the allocation of the participants, a computer‐generated list of binary random numbers was used.” |
Allocation concealment (selection bias) | Low risk | Allocation concealment was described as by central allocation. Quote: "The sequence was concealed and the following number (0: Group 1; 1: Group 2) was disclosed by a person not involved in the enrolment process, every time a new patient was added.” |
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. |
Blinding of outcome assessment (detection bias) Fractures | Unclear risk | Insufficient information to permit judgement. No fractures reported (as no injurious falls) and unclear how data regarding fractures was collected. |
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. |
Method of ascertaining falls (recall bias) Falls and fallers | Unclear risk | The study used some form of concurrent collection of data about falling‐ i.e. falls diaries, but frequency of follow‐up by the researchers was not reported. |