Lin 2014.
Study characteristics | ||
Methods |
Design: RCT Duration of trial: 15/16 months (July 2011 to November 2012) Unit of randomisation: people with stroke of 6–10 months' duration with executive function and memory deficits; aged 45–70 years Recruitment and allocation: patients attending a rehabilitation hospital were recruited and randomly allocated to 1 of 2 groups: IG (n = 16) and CG (n = 18) |
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Participants |
Setting: rehabilitation department of 1 rehabilitation hospital Country: China Sample size: 34 adults, 59% men; IG: 16; CG: 18 Inclusion criteria: confirmed diagnosis of first stroke; deficits in both executive function and memory (z‐scores < 1.5 in the Wechsler Memory Scale memory quotient and TMT); right handed; education ≥ 8 years; time since stroke 6–10 months (180–300 days); aged 45–70 years; normal hearing and vision Exclusion criteria: mental retardation; history of Alzheimer's disease or mental illness such as schizophrenia before stroke; vital organ failure; concomitant antidepressant, psychoactive drug, or steroid therapy Age: mean: IG: 62.4 (SD 6.0) years; CG: 63.2 (SD 5.7) years Time since onset of stroke: mean: IG: 227.5 (SD 24.0) days; CG: 228.1 (SD 18.4) days Types of stroke: not reported Site of lesion: n (left/right hemisphere): IG: 6/10; CG: 9/9 |
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Interventions |
Intervention group Brief name: RehaCom Recipients: adults in rehabilitation 6–10 months since stroke with executive function and memory deficits. Why: to improve executive function and memory. What (materials): RehaCom software; see hasomed.de/en/products/rehacom/; the software is available in 27 languages at no extra cost; computer. What (procedures): CT; no further description of procedures provided. Who provided: 2 trained psychologists; the RehaCom website states that the software is used "extensively by … occupational therapists" and other clinicians in rehabilitation centres, hospitals, and clinics. How: not described but presumably face‐to‐face Where: not described but presumably in the rehabilitation department When and how much: 1 hour per session, 6 sessions per week for 10 weeks (60 hours in total) Tailoring: none reported Modifications: none reported How well (planned): none reported How well (actual): none reported Comparator group Brief name: CG Recipients: adults in rehabilitation 6–10 months since stroke with executive function and memory deficits Why: to provide rehabilitation. What: not described except that no CT was provided. Who provided: not reported How: not reported Where: not reported, presumably within the rehabilitation department When and how much: not reported Tailoring: none reported Modifications: none reported How well (planned): not reported How well (actual): not reported |
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Outcomes |
Primary: none Secondary
Other
Methods of data collection: neuropsychological assessments performed by 2 trained psychologists who were blinded to group assignment. Data collection time points: baseline and after intervention (10 weeks) |
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Notes |
Funding: yes Conflict of interest: none Published trial protocol: none located Trial registration: none reported Ethics approval: yes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Used random number table. |
Allocation concealment (selection bias) | Unclear risk | Method of allocation not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding or not was not reported but it was apparent that participants could have known which group they were allocated to. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Neuropsychological assessments were performed by 2 trained psychologists who were blinded to group assignment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number randomised was unclear, just the number who completed the study was reported. |
Selective reporting (reporting bias) | Low risk | It appears that all planned outcomes were reported. |
Other bias | Low risk | No other identifiable bias. |