Volpe 2014a.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: facility, Italy N = 40 Sample: recruited from the Neurorehabilitation Unit of ‘‘S. Raffaele Arcangelo’’ Hospital (60% women) Age (years): median (Q1; Q3) intervention group 66.5 (64.0; 78.0) control group 69.5 (65.0; 73.8) Inclusion criteria: diagnosis of PD; HY stages 2 and 3 on levodopa; ≥ 1 fall in the past year; presence of postural alterations; presence of postural instability; ability to attend a physiotherapy venue; absence of cognitive impairment (Mini‐mental State Examination > 24/30); stable medications Exclusion criteria: medication‐induced dyskinesias; presence of co‐morbidities preventing mobility or safe exercise (including clinically evident neuropathy and major medical conditions such as malignancies); history of deep brain stimulation surgery; other conditions affecting stability (e.g. poor visual acuity or vestibular dysfunction); HY stage ≥4 on levodopa; an inability to travel to the physiotherapy venues Disease severity at baseline: HY stage 2 to 3, UPDRS motor score median intervention group = 42, control group = 39.5 |
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Interventions | Exercise 1. Exercise: perturbation‐based balance training program wearing 3 proprioceptive devices. Individual treatment supervised by a physiotherapist (60 minutes, 5x/week for 8 weeks) 2. Control: perturbation‐based balance training program wearing 3 inactive devices. Individual treatment supervised by a physiotherapist (60 minutes, 5x/week for 8 weeks) |
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Outcomes | 1. Rate of falls 3. Quality of life (PDQ‐39) Other outcomes reported but not included in this review |
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Duration of the study | 4 months | |
Funding source | No funding | |
Notes | Fall data collected: at baseline, within 1 week after the intervention period and at two months after the end of treatment by falls diaries | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of generating the randomisation list not described. Quote: "A blocked stratified randomization procedure conducted by a third party and based on the Hoehn & Yahr score was used to allocate participants to one of the two treatment groups…” |
Allocation concealment (selection bias) | Low risk | Allocation concealment was described. Quote: "A blocked stratified randomization procedure conducted by a third party...” |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants and personnel implementing the intervention assured. Quote: "...patients were blinded to the group allocation during the whole duration of the study. The study coordinator responsible for WPS placing (M.G.G.) was not blinded to group allocation, but she was not involved in rehabilitation procedures or outcome assessment. The therapists providing the interventions were blinded and not involved in other aspects of the trial (i.e., aims, hypotheses or predictions of the study were not disclosed). Both active and placebo WPSs were identical and did not cause any recognizable sensory sensation, thus guarantying patients’ blindness.” |
Blinding of outcome assessment (detection bias) Falls and fallers | Low risk | Outcomes were recorded/confirmed in all allocated groups using the same method and the personnel recording/confirming falls were blind to group allocation. Quote: "The two trained assessors and patients were blinded to the group allocation during the whole duration of the study” |
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) | 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 | Details of ascertainment were not described. Quote: “Falls were recorded by means of fall diaries of the previous two months.” |