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. 2013 May 31;2013(5):CD002842. doi: 10.1002/14651858.CD002842.pub2

Winkens 2009

Methods RCT, multicentre study, parallel group design
Random assignment list created before start of trial, independent person used the list to assign people to the 2 groups after recruitment
Approach: learning of compensatory strategies
Participants Netherlands, recruited from 8 rehabilitation centres
Total participant sample 37: 2 lost at post‐treatment assessment, another 1 at 3‐month follow‐up
Treatment group: n = 20; mean age 49.5 ± 8 years; 45% males; 19.3 ± 29.6 months since onset Control group: n = 17; mean age 53.9 ± 11.1 years; 71% males; 6.9 ± 5.4 months since onset
No data for hemisphere of lesion, and aetiology
Inclusion criteria: stroke > 3 months; referred for cognitive rehabilitation for mental slowness
Exclusion criteria: aged < 18 years; stroke < 3 months; severe or disabling premorbid or current (continuing) pathological conditions; severe cognitive, communication, physical, or psychological problems that the person was unable to perform the tasks, based on the clinical judgement of the treating team
Interventions Treatment: 10‐hour teaching in time pressure management session duration varied between 1 and 2 hours a week depending on the individual person
Control: care as usual
Outcomes Measured after intervention (time not explicitly specified, but likely to be around 5 weeks) and at 3‐month follow‐up
Primary outcomes:
  • information intake task (number of correct responses and used strategies

  • Mental Slowness Observation test (time, number of correct responses and used strategies)

  • Mental Slowness Questionnaire (raw score)


Secondary outcomes:
  • PASAT (number of correct responses at 3.2 seconds ISI)

  • Trail Making A & B (time in seconds for both parts)

  • Simple Reaction Time (time in seconds)

  • Stroop (time in seconds for each subtest)

  • Symbol Digit Modalities test (number of correct responses)

  • Auditory Verbal Learning test (number of correct responses)

  • Fatigue Severity Scale (raw scores)

  • EuroQol‐5D (raw scores)

  • Depression Scale (raw scores)

Notes People with stroke were relatively young and ADL‐independent. Control group were more recent after onset. Additional data for analysis provided by the authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Random assignment list" was used, no details given
Allocation concealment (selection bias) Low risk After selection of participants independent person used random list to assign people to groups
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Participants and therapist not blinded
Blinding of outcome assessment (detection bias) All outcomes Low risk Assessment by blinded research assistant. Analyses showed that assistant had guessed the allocation correctly in 24 of 37 cases (Cohen k = 0.29, P value = 0.05)
Incomplete outcome data (attrition bias) All outcomes Low risk Missing outcome data balanced in numbers across intervention groups
Selective reporting (reporting bias) Low risk No indication in article, but study protocol not available

ADL: activities of daily living; APT: attention process training; CT: computerised tomography; DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; FIM: Functional Independence Measure; GHQ: general health questionnaire; ISI: inter‐stimulus interval; IVA‐CPT: Integrated Visual and Auditory Continuous Performance Test; MRI: magnetic resonance imaging; MMSE: Mini‐mental state examination; PASAT: Paced Auditory Serial Addition Test; PET: positron emission tomography; RCT: randomised controlled trial; SD: standard deviation; SF: Short Form; TBI: traumatic brain injury; WAIS: Wechsler Adult Intelligence Scale; WHO: World Health Organization