Zeloni 2002.
Study characteristics | ||
Methods | RCT Setting: Italy | |
Participants | 8 randomised (see Notes) Experimental: n = 4, control: n = 4 Mean age, years: experimental = 68.8, control = 76.3 Sex (men/women): 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, removing them only to go to sleep (the right side of each lens was blinded) vs no goggles All 8 participants were involved in the hospital's daily activities including usual treatment for neglect, tasks to train compensation for faulty scanning | |
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 goggle treatment ended. Controls were assessed at the same time points but never wore the hemi‐blinding goggles. Testing was performed without goggles. Outcomes used were line, letter, and bell cancellation, copy drawing, line bisection For this version of the review, we used 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 study authors confirmed the methods used and provided data. The 8 randomised participants are numbers 1 to 4 in treatment and control groups as listed in the study authors' Table 9, 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 used only the 8 randomised participants Cancellation tests were scored as number correct. Line bisection was scored as % correct, decreasing for rightward deviation. Study authors provided raw data (%) for the 8 participants on line bisection. Mean (SD) values were as follows: 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 |
Random sequence generation (selection bias) | High risk | See below |
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). Label preparation was performed by a member of the trial team, but selection was performed by a student who had no previous or later involvement in the trial. Although allocation was done externally, the method used did not permit verification |
Blinding of participants | High risk | Blinding not possible |
Blinding of personnel | High risk | Blinding not possible |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No details |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcomes |
Selective reporting (reporting bias) | Low risk | Outcomes reported equally |
Other bias | Unclear risk | No baseline adjustments made ‐ controls seem somewhat older, although sample was very small |
ADL: activities of daily living. ASMP: auditory subjective median plane. BI: Barthel Index. BIT: Behavioural Inattention Test. CBS: 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. FT: feedback training. GHQ: General Health Questionnaire. GVS: Galvanic Vestibular Stimulation. HFVS: Harrington Flocks Visual Screener. HHA: homonymous hemianopia. HI: head injury. IQR: interquartile range. LAT: limb activation training. LBT: line bisection test. 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. rTMS: repetitive transcranial magnetic stimulation. SCT: star cancellation test. SD: standard deviation. SEM: standard error of the mean. SIAS: Social Interaction Anxiety Scale. SIS: Stroke Impact Scale. SU: stroke unit. tDCS: transcranial direct current stimulation. 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.