Westerberg 2007
| Methods | RCT, parallel group design 3 people who did not take part in the study performed the randomisation. Small identical paper notes with numbers corresponding to each of the participants were put in a bucket. The notes were folded so that it was impossible to see the numbers. 1 person held the bucket, the 2 other people drew notes in an alternating manner. Before the procedure it was determined that all participants drawn by the first person would be in the training group, and the participants drawn by the other person were controls. The principal investigator (not involved in randomisation process) had the key to the correspondence between the numbers and the participant names. The result of the randomisation was kept secret from the therapists. After the first neuropsychological assessment (T1) a sealed, pre‐named envelope, which revealed the randomisation to either the treatment or control group condition, was opened by the therapist so that the participants could have the instructions for their intervention Approach: restore attentional functions by computer training of working memory functions |
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| Participants | Sweden, recruited from 1 hospital Total participant sample 21; 3 lost after baseline testing (only data of remaining people reported) Treatment group: n = 9; mean age 55.0 ± 8 years; 89% males; 19.3 ± 6.2 months since onset; hemisphere of lesion: 4 left (44%), 4 right (44%), 1 unclear (11%) Control group: n = 9; mean age 53.6 ± 8 years; 44% males; 20.8 ± 6.2 months since onset; hemisphere of lesion: 3 left (33%), 4 right (44%), 2 unclear (22%) Inclusion criteria: self reported deficits in attention; suffering stroke between 12 and 36 months ago; stroke documented by PET, MRI or CT; aged 30 to 65 years; having daily access to a computer with Internet connection at home Exclusion criteria: IQ < 70; motor or perceptual handicap that would prevent use of the computer program; changing medication during the study period; fulfilling criteria for major, depressive‐disorder diagnosis as per the DSM‐IV diagnosis code |
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| Interventions | Treatment: 40 minutes of computer‐based training at home for 5 days per week for 5 weeks in total. Visuo‐spatial and auditory working memory tasks were performed by using the RoboMemo Software (Cogmed Cognitive Medical Systems, Sweden). Sufficient compliance was defined as 20 days of training (achieved by all participants not withdrawing from the study) Control: no training |
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| Outcomes | Measured after intervention (5 weeks) Several measures, but no definition of primary outcome measure:
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| Notes | The study authors informed on an error in the original paper. The correct Ruff 2&7 values for the treatment group were 130.3 (21.9) seconds at pre‐training and 115.4 (21.7) seconds at post‐training | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Sealed envelopes prepared by a person unrelated to the study |
| Allocation concealment (selection bias) | Low risk | Sealed pre‐addressed envelope (prepared by persons unrelated to the study) opened after the initial assessment |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and therapist not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Assessor not blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data balanced in numbers across intervention groups, lost participants scored within group mean level in the baseline |
| Selective reporting (reporting bias) | Low risk | No indication in article, but study protocol not available |