Prosperini 2013.
Methods | Single‐blinded randomised cross‐over trial. Allocation by computer‐generated random numbers in a 1:1 ratio. | |
Participants | n = 36 Randomised: GA = 18, GB = 18 Analysed: GA = 17, GB = 17 No significant difference between groups at baseline for demographic & clinical characteristics |
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Interventions | 30 minutes/day, 5 days/week for 12 weeks use of Wii Fit Plus balance games of progressive difficulty, at home | |
Outcomes | Number of falls per group, static balance function, dynamic balance function, mobility, MS impact (physical and psychological) | |
Notes | GA: Group A, GB: Group B, COP Path Centre of Pressure Path, FSST: Four Step Square Test, 25‐FWT: 25 Foot Walk Test, MSIS‐29: Multiple Sclerosis Impact Scale‐29, WBBS: Wii Balance Board System | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Patients who met all eligibility criteria underwent study assessments and were randomly assigned in a 1:1 ratio to 2 counterbalanced arms by computer‐generated random numbers. Randomization procedure was performed by an operator (LL) not involved in study measurements” |
Allocation concealment (selection bias) | Unclear risk | Insufficient information available to permit a judgement of ‘low risk’ or ‘high risk’. This is usually the case if the method of concealment is not described or not described in sufficient detail to allow a definite judgement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information available to permit a judgement of ‘low risk’ or ‘high risk’ |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The following outcome measures were collected at each scheduled visit (T0, T1, and T2) by 2 neurologists (LP and CG) unaware of the training order allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups. |
Selective reporting (reporting bias) | Unclear risk | Registered trial protocol is not cited in paper so it is not possible to check against planned a‐priori analyses |
Other bias | Unclear risk | No sample size calculated and inferential statistics calculated. Study may be exposed to a type II error |