Zeloni 2002.
| Methods | RCT Setting: Italy |
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| Participants | 8 randomised (see Notes) Experimental: n = 4, control: n = 4 Mean age: experimental: 68.8 years, control: 76.3 years Sex (male/female): experimental: 4/0, control: 2/2 Mean months post‐stroke: experimental: 11.25, control: 4.5 Inclusion: "post‐acute" patients with right hemisphere vascular lesions and neglect, admitted to hospital, right‐handed, left hemiplegic Exclusions: normally wore glasses | |
| Interventions | Wearing plastic goggles for 1 week, only removing them to go to sleep (the right side of each lens was blinded), versus no goggles All 8 participants were involved in the hospital's daily activities including the usual treatment for neglect, tasks to train compensation for faulty scanning For analysis of bottom‐up and top‐down rehabilitation approaches this review coded the experimental condition as bottom‐up | |
| Outcomes | Participants were assessed on 3 occasions: at recruitment, after the experimental group had received 1 week of hemi‐blinding goggles, and again 1 week after the goggle treatment ended. Controls were assessed at the same time points but never wore the hemi‐blinding goggles. Testing was performed without goggles. The outcomes used were: line, letter and bell cancellation, copy drawing, line bisection For this version of the review we used the single letter cancellation outcome data only. We used data from the third time point; as this was only 1 week after intervention it is coded in this review as 'immediate' effects | |
| Notes | Personal communication from the authors confirmed the methods used and provided data. The 8 randomised participants are numbers 1 to 4 in the treatment and control group as listed in the authors' Table 1, page 196. The original study recruited 11 participants. The first 8 were randomised as described above. The other 3 were non‐randomly added to the groups (1 to treatment and 2 to control). This review only used the 8 randomised participants Cancellation tests were scored as number correct. Line bisection was scored as % correct decreasing for rightward deviation. Authors provided raw data (%) for the 8 participants on line bisection. The mean (SD) were: experimental: 62.5 (35.2), control: 73.8 (22.2). These data were used in the 2006 version of this review, but for this version the number of neglect outcomes was reduced and the line bisection data removed | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | High risk | For the first 8 participants group allocation was performed by randomly selecting a label from a pre‐printed set of 8 (see Notes). The label preparation was performed by a member of the trial team but the selection was performed by a student who had no previous or later involvement in the trial. Although the allocation was done externally the method used did not permit verification |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded outcome assessor |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcomes |
| Free of systematic differences in baseline characteristics of groups compared? | Unclear risk | Controls seem somewhat older, though sample very small |
| Did authors adjust for baseline differences in their analyses? | Unclear risk | No adjustment made |
ADL: activities of daily living ASMP: auditory subjective median plane BI: Barthel Index BIT: Behavioural Inattention Test CBS OT: Catherine Bergego Scale occupational therapist’s evaluation score cm: centimetre CT: computerised tomography CVA: cerebrovascular accident FA: functional approach FAI: Frenchay Activities Index FIM: Functional Independence Measure GHQ: General Health Questionnaire HFVS: Harrington Flocks Visual Screener HHA: homonymous hemianopia HI: head injury LAT: limb activation training mm: millimetre MMSE: Mini Mental Status Exam MVPT: Motor Free Visual Perception Test N/A: not applicable Nottingham EADL: extended ADL index OKS: optokinetic stimulation OT: occupational therapy/therapist RBD: right brain damage RCPM: Raven's Coloured Progressive Matrices RCT: randomised controlled trial Rey CFT: Rey Osterreith Complex Figure Test RH: right hemisphere RMA: Rivermead Motor Assessment RPAB: Rivermead Perceptual Assessment Battery SD: standard deviation SEM: standard error of the mean SIAS: Social Interaction Anxiety Scale SU: stroke unit TENS: transcutaneous electrical nerve stimulation TIA: transient ischaemic attack ToT: transfer of training VN: visual neglect WAIS‐R: Revised Weschler Adult Intelligence Scale WMFT: Wolf Motor Function Test WRAT: Wide Range Achievement Test