Methods | Setting: rehabilitation hospital Sites: 1 Countries: Canada Trial design: parallel (first 10 recruited participants only) Recruitment dates: not reported Duration: 30 months | |
Participants | Number: 10 randomised, further 10 systematically allocated. Report pools data Definition of stroke: included radiology (all had CT scan) Time since stroke: not reported separately for randomised participants; range within 1 to 5 months Time since start of rehabilitation: not reported separately for randomised participants Comorbidities affecting disability: not reported Excluded: previous stroke, pre‐existing visual impairment, cataracts, glaucoma, diabetes, psychological distress Tools used to define perceptual disorders: participants not chosen on basis of perceptual impairment. Authors state 5 measures of visuospatial functioning were taken: Rey‐Osterreith (copy and recall), WAIS block design, Raven’s Coloured Matrices, Benton’s Line Orientation. These may test memory and executive functioning as well as perception Severity of perceptual disorders: not reported separately for randomised participants Included visuospatial neglect: unclear; if ‘yes’, frequency/severity Age: not reported separately for randomised participants Sex: not reported separately for randomised participants Race/ethnicity: not stated | |
Interventions | Described adequately to replicate: no Broad class: sensory stimulation Specific nature: the experimental intervention consisted of Bracy's computerised visuospatial training package, which comprised 7 different visuospatial exercises (paddle ball, fine motor, maze, cube in the box, line orientation I, line orientation II, visual perception test) The control group received routine rehabilitation therapies provided by the hospital Frequency: 3 x 30‐minute sessions per week Duration (from first to last treatment): 4 weeks Profession of 'therapist': 2 trained research assistants (professional background unknown) Co‐interventions: all participants received routine rehabilitation therapies provided by the hospital, including physiotherapy and occupational therapy treatment Excluded: no | |
Outcomes | Reported:
Specified primary outcome(s): no, impairment and activity level measures with no explicit hierarchy. Addressed "large number of test variables" using Dunn‐Sidak procedure to adjust nominal significance level rather than through hierarchy of outcome measures Time points for outcomes: end of intervention Total number of outcomes: > 40 in battery (detailed in appendix) Possible ceiling/floor effects ‐ identified by trialists: no; identified by reviewer: yes (e.g. Table 2 Barthel) Assessed by: third party for neuropsychological battery, nurses for functional indices and physiotherapists for mobility |
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Notes | Only 10 randomised participants. All results given for 19 completers or 20 allocated participants. Would need data from authors for inclusion in meta‐analyses. Unsuccessful attempts to contact authors | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Not specified beyond "the first 10 patients were randomly assigned" |
Allocation concealment? | Unclear risk | No information on process |
Blinding? All outcomes | High risk | Partial: intended blinded assessment of ADL but not of perceptual impairments. Not reported success of blinding |
Incomplete outcome data addressed? All outcomes | Low risk | 1 discharged prior to outcome assessment. Not clear whether this was one of the first 10 randomised participants |
Free of selective reporting? | High risk | Results tabulated only for statistically significant results within test battery |
Free of other bias? | High risk | Participants 11 to 20 allocated systematically "so as to match the already assigned patients" |