Cattaneo 2019.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: facility and home, Italy N = 32 (PD subgroup) Sample: recruited from three Italian field centres by a group of researchers and clinicians (physiotherapists and medical doctors ‐ the NEUROFALL group) (37% women in whole sample ‐ not reported for PD subgroup) Age (years): mean (SD) intervention group 61 (15), control group 63 (11) (whole sample) Inclusion criteria: diagnosis of PD; able to walk 10 metres independently with or without a mobility aid; willing to commit to the educational program; able to give written informed consent Exclusion criteria: major depression; severe bone/joint disorder interfering with mobility; cognitive impairment (Mini‐mental State Examination score < 21) Disease severity at baseline: not reported |
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Interventions | Exercise plus education 1. Education and exercise: one, one‐hour education session about fall‐prevention delivered by a physical therapist to a small group ranging in size from two to four people. Exercise focused on mobility and balance and was tailored to the individual. Three, one‐hour supervised sessions, followed by home‐based unsupervised exercise two to three times per week for two months 2. Control: usual treatments, plus two, one‐hour sessions to learn stretching exercises, followed by independent performance of stretching exercises at home for two months |
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Outcomes | 1. Number of fallers Other outcomes reported but not included in this review |
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Duration of the study | 6 months | |
Funding source | Italian Ministry of Health (RF‐2010‐2318552) | |
Notes | Fall data collected: with a fall diary and a second monthly phone call for 6 months | |
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: “…using a computer generated randomization list generated before commencement of the study… using random block sizes of 4.” |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement as a method of concealment is not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and intervention (exercise and education) delivery personnel not blinded to group allocation but impact of non‐blinding unclear. |
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 outcomes were blind to group allocation. Quote: "Data were collected by trained interviewers blinded to the intervention not located in the clinical centers where the assessments were made." |
Incomplete outcome data (attrition bias) Fallers | Low risk | See appendix for method of assessment. Data not available for calculation ‐ however, no dropouts in either group. |
Selective reporting (reporting bias) | Low risk | The study protocol is available (NCT03570268) and all of the study’s pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way. |
Method of ascertaining falls (recall bias) Falls and fallers | Unclear risk | The study used concurrent collection of data about falling however follow‐up by the researchers was every 2 months. The effect of the longer time frame for researcher follow‐up is unclear Quote: "Each patient was given a fall diary and was followed for 6 months with telephone contacts approximately at 2, 4, and 6 months." |