Yoo 2015.
Study characteristics | ||
Methods |
Design: parallel RCT Duration of trial: 6 months (October 2013 to March 2014) Unit of randomisation: inpatients with cognitive impairment after stroke Recruitment and allocation: people with stroke receiving inpatient rehabilitation; 46 participants randomised to IG (n = 23) or CG (n = 23) |
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Participants |
Setting: university hospital Country: Republic of Korea Sample: 46 adults, 37% men; IG: 23; CG: 23 Inclusion/exclusion criteria: not reported Age: mean: IG: 53.2 (SD 8.8) years; CG: 56.3 (SD 7.9) years Time since stroke onset: mean: IG: 11.8 (SD 7.5) months; CG: 10.7 (SD 6.2) months |
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Interventions |
Intervention group Brief name: RehaCom training Recipients: inpatients with stroke with cognitive impairment undergoing rehabilitation Why: to provide computer‐based cognitive rehabilitation to improve attention, focus, memory, spatial imagination, visual impairment, and visuomotor co‐ordination. What (materials): RehaCom software (Hasomed GmbH, Magdeburg, Germany; see hasomed.de/en/products/rehacom/; the software is available in 27 languages at no extra cost; computer. What (procedures): in addition to rehabilitation therapy, a computerised cognitive rehabilitation programme using the RehaCom software composed of 20 detailed training programs targeting attention, focus, memory, spatial imagination, visual impairment, and visuomotor co‐ordination Who provided: not reported; however, the research was conducted by occupational therapists. The RehaCom website states that the software is used (quote) "extensively by … occupational therapists" and other clinicians in rehabilitation centres, hospitals, and clinics. How: not reported, but appeared to be face‐to‐face and individually Where: inpatient rehabilitation in local hospital When and how much: 25 sessions of 30 minutes per day (5 times per week for 5 weeks) (12.5 hours in total) Tailoring: RehaCom reportedly (quote) "enables adjustment of difficulty based on the task performance capacity of the patient, immediate feedback, reduction in time spent by the therapist once the patient learns the therapy task, and maintenance of objective and continuous information concerning performance results". Modifications: none reported How well (planned): none reported How well (actual): none reported Comparator group Brief name: rehabilitation therapy Recipients: inpatients with stroke with cognitive impairment undergoing rehabilitation Why: to provide usual inpatient rehabilitation. What (materials): not reported What (procedures): included physical and occupational therapy Who provided: included physical and occupational therapists How: not reported, assumed face‐to‐face Where: inpatient rehabilitation in local hospital When and how much rehabilitation: not reported Tailoring: none reported Modifications: not reported How well (planned): not reported How well (actual): not reported |
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Outcomes |
Primary
Secondary Computerised Neuropsychological Test, including:
Methods of data collection: cognitive assessment was conducted by computerised testing; method of ADL assessment with FIM not described. Data collection time points: baseline and after 5 weeks of computerised cognitive rehabilitation |
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Notes |
Funding: not stated Conflict of interest: none reported Published trial protocol: none reported 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) | Unclear risk | Participants were randomly divided into IG and CG with no further description of procedure. |
Allocation concealment (selection bias) | Unclear risk | Participants were randomly divided into IG and CG with no description of procedure. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | It appeared the participants and personnel would have known which group received the additional cognitive rehabilitation program. Quote: "The participants understood the objective of this study … The training group received rehabilitation therapy and an additional computerized cognitive rehabilitation program using the RehaCom software 30 minutes/day, 5 times/week for 5 weeks. The control group received only rehabilitation therapy, including physical and occupational therapy". |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported; unclear who administered the FIM. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Study did not address this criterion. |
Selective reporting (reporting bias) | Low risk | All relevant outcomes from method reported. |
Other bias | Low risk | No other identifiable bias. |