Rossi‐Izquierdo 2013.
Methods | Design: randomised controlled trial, with balanced block randomisation | |
Participants |
Number: 26 Age: intervention group: mean age 59.3 (SD 13.5), comparator group: mean age 63.3 (SD 16.1) Gender: intervention group: 7 males, comparator group: 3 males Setting: Department of Otolaryngology, university hospital Eligibility criteria: participants with instability due to chronic unilateral peripheral vestibular disorders which had not spontaneously resolved after a month. Hypofunction was defined with caloric tests, at least 25% labyrinthic preponderance according to defined criteria Exclusion criteria: inner ear and pontocerebellar lesions, post‐traumatic conditions, locomotor disturbance preventing standing, previous instrumental VR or the lack of a complete evaluation Baseline characteristics: there were no differences in age, gender or duration of symptoms, but 2 of the baseline posturography measures were significantly different between the groups at baseline |
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Interventions |
Intervention group: 5 sessions of posturography‐assisted VR over a 2‐week period (n = 13) Comparator group: 10 sessions of posturography‐assisted VR over a 2‐week period (n = 13) VR versus VR |
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Outcomes |
Primary outcome: DHI Secondary outcome: posturography |
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Notes | No participants were lost to follow‐up | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "We used balanced block randomisation" |
Allocation concealment (selection bias) | Unclear risk | An independent researcher assigned participants to groups |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "The person who performs the VR in each hospital was neither of the other people who assigned the patients to groups and evaluated the treatment" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It appears as though all participants completed the study but numbers of participants are not provided in the results |
Selective reporting (reporting bias) | Low risk | Study protocol not available but all data appear to be reported |
Other bias | Low risk | The study appears to be free of other sources of bias |