Gandolfi 2017.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: home (virtual reality telerehabilitation group) and facility (sensory‐integration balance training group), Italy N = 76 Sample: recruited from four neurorehabilitation units in Veneto, Italy (predominantly rural areas) (33% women) Age (years): mean (SD) virtual reality telerehabilitation group 67.5 (7.2), sensory‐integration balance training group 69.8 (9.4) Inclusion criteria: diagnosis of PD according to the UK Brain bank criteria; aged over 18 years; modified Hoehn and Yahr stage 2.5 to 3; stable medication for the past month; able to transfer and maintain upright standing for at least 10 minutes; presence of a caregiver Exclusion criteria: cardiovascular, orthopaedic and otovestibular disorders; visual or other neurological conditions that could interfere with balance; severe dyskinesias or on‐off fluctuations; Mini‐mental State Examination score < 24/30; severe depression measured on the Geriatric Depression scale. Disease severity at baseline: HY stage 2.5 to 3, UPDRS total score mean (SD) 47.4 (24.1) |
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Interventions | Exercise 1. Virtual reality telerehabilitation balance training: Nintendo Wii Fit exergames (Nintendo Co., Ltd., Kyoto, Japan) delivered via telehealth (Skype, Microsoft, USA) to participants in their homes, two participants at a time (50 min, 3x/week for 7 weeks) 2. Sensory integration balance training: balance exercises under different sensory conditions, delivered individually at a facility (50 minutes, 3x/week for 7 weeks) |
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Outcomes | 1. Rate of falls 2. Quality of life (PDQ8) 3. Cost of delivering the intervention Other outcomes reported but not included in this review |
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Duration of the study | 11 weeks | |
Funding source | Ricerca Sanitaria Finalizzata Regionale, 2010 (grant no. 319/10) | |
Notes | Fall data collected: for the prior 1 month in a self‐report logbook, measured at 7 weeks (post intervention) and 11 weeks (follow‐up) | |
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: "After screening, a list was generated using computer‐generated random number tables (allocation ratio 1:1). Eligible patients were consecutively entered into the list." |
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 (two different exercise interventions) 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: "At each study center, outcomes were assessed by a single examiner blinded to treatment assignment." |
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 of ‘Low risk’ or ‘High risk’ as no published trial protocol or trial registration available. |
Method of ascertaining falls (recall bias) Falls and fallers | Unclear risk | Deatails of ascertainment were not described. Quote: "The number of falls in the previous month was recorded in a self‐report log." |