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. 2022 Jun 6;2022(6):CD011574. doi: 10.1002/14651858.CD011574.pub2

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)
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)
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
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."