Garcia 2013.
| Methods | Design: randomised controlled trial | |
| Participants |
Number: 44 Age: intervention group age = 48 (range 20 to 60), control group age = 48 (range 19 to 60) Gender: intervention group 9 males, control group 7 males Setting: university medical school Eligibility criteria: Participants were included if they had Ménière's disease diagnosed by an ENT specialist and had complaints of dizziness between exacerbations of their disease Exclusion criteria: Participants were excluded if they had suffered a bout immediately before the study, if they had rheumatic disease, uncontrolled hypertension, heart disease, severe visual involvement or decompensated involvement despite corrective lenses, orthopaedic disorders or joint replacements affecting the lower limbs, psychiatric disorders, were unable to communicate or stand independently, those who had been involved in balance rehabilitation programmes in the past 6 months, those in the intervention group who did not attend 3 consecutive intervention sessions, and those who failed to follow the diet and other advice to cease alcohol, refined sugar, coffee and smoking and take betahistine Baseline characteristics: At baseline participants reported their frequency and duration of dizzy spells, with no differences between the groups |
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| Interventions |
Intervention group: 12 rehabilitation sessions (twice weekly for 45 minutes) with virtual reality stimuli in a Balance Rehabilitation Unit, plus diet and lifestyle advice and betahistine (n = 23) Control group: 12 stimulus enriched exercise sessions (twice weekly) in the Balance Rehabilitation Unit, plus diet and lifestyle advice and betahistine (n = 21) VR versus control (usual care) |
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| Outcomes |
Primary outcome: dizziness analogue scale scores Secondary outcomes: DHI, posturography Intervention participants were assessed 6 weeks after completion of the 12 sessions, while comparator group participants were assessed immediately after the 12 sessions (6 weeks) |
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| Notes | Participants lost to follow‐up: nil, but intervention group participants who missed more than 3 consecutive sessions were excluded from the study (number not reported) Intervention participants improved significantly on the DHI, dizziness analogue scale and had greater stability on posturography compared to control participants |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was performed using "a table with uniformly distributed random numbers produced by a computer program" pg 368 |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information about the method of allocation |
| Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "The evaluations and the rehabilitation program were carried out by the head researcher" pg 369 |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants were available for follow‐up assessments |
| Selective reporting (reporting bias) | Low risk | Study protocol not available but all data appear to be reported |
| Other bias | High risk | Excluding participants who missed intervention sessions does not allow for evaluation of participant compliance. The different time periods for assessing outcomes post intervention allows for the potential bias that the intervention group may have simply recovered over time due to the lifestyle changes |