Methods | Setting: Rivermead Rehabilitation Centre Sites: 1 Countries: UK Trial design: parallel Recruitment dates: June 1981 to end November 1982 | |
Participants | Number: 33 analysed Definition of stroke: unspecified; included 21 (64%) with stroke, 6 (18%) each with head injury and subarachnoid haemorrhage Time since stroke: 2.7 months, SD ≈ 1.8 (Table 4), mean (SD) in experimental group 2.4 (1.0) months, control group 3.1 (2.4) months Comorbidities affecting disability: not reported Excluded: no Tools used to define perceptual disorders: Rivermead Perceptual Assessment Battery (RPAB) Severity of perceptual disorders: 3 or more subtests on which performance was > 2 SDs from mean for normal non‐brain damaged adult score Included visuospatial neglect: yes probably: frequency/severity: not stated, but they did not exclude people with neglect Age: mean 50 years, range 17 to 69 years; mean (SD) in experimental group 49 (14.6) years, control group 51 (16.0) years Sex: 17 (52%) male: experimental group 9 (53%), control group 8 (50%) | |
Interventions | Described adequately to replicate: no Broad class: sensory stimulation Specific nature: the experimental group practiced various perceptual tasks (e.g. stick length sorting, picture lotto, colour matching squares, shape recognition games) of the type commonly used in occupational therapy departments The control group received the same amount of therapy time but carried out activities that were designed to improve physical rather than perceptual abilities (e.g. games, craft work, gardening) Frequency: 4 hours per week Duration (from first to last treatment): 4 weeks Profession of 'therapist': not explicitly stated but 'Acknowledgements' section suggests that occupational therapists carried out the experimental intervention and also provided activities for the control group Co‐interventions reported: any occupational therapy provided in addition to the 4 study hours per week was aimed at gross motor performance and provided to both groups Excluded: no | |
Outcomes | Reported:
Adverse events:
Specified primary outcome(s): no, 16 tests of RPAB and ADL presented with no apparent hierarchy Time points for outcomes: end of intervention Total number of outcomes: 17, includes 16 measures of perception in RPAB but no overall score Possible ceiling/floor effects: evident from presented means and SD for some subtests of the RPAB Assessed by: third party "unaware of the treatment group" |
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Notes | Personal communication | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | No detail beyond "patients were randomly allocated" |
Allocation concealment? | Unclear risk | No information on process |
Blinding? All outcomes | High risk | Intended blinded outcome assessment, but not reported success |
Incomplete outcome data addressed? All outcomes | Low risk | No suggestion of loss to follow‐up |
Free of selective reporting? | Low risk | No suggestion of unreported outcomes |
Free of other bias? | Unclear risk | Original eligibility criteria restricted entry to right‐hemisphere stroke patients. Later extended to head injury, subarachnoid haemorrhage and left hemisphere stroke "to obtain reasonable numbers within the time". Not clear what interim analyses were undertaken, and possible consequences for interpretation of the final data |