Cho 2015.
Study characteristics | ||
Methods |
Design: parallel RCT Duration of trial: 2 months (December 2013 to January 2014) Unit of randomisation: people with hemiparetic stroke onset within 3 months to 1 year Recruitment and allocation: recruited successively from 30 hospitalised stroke patients who were receiving occupational and physical therapy and randomised to the either CACR (n = 12) or CG (n = 13). |
|
Participants |
Setting: 1 general hospital Country: Republic of Korea Sample size: 25 adults, 64% men; CARC: 12 (58% men); CG: 13 (69% men) Inclusion criteria: hemiparetic stroke of onset within 3 months to 1 year, able to follow verbal instructions, communicate to a certain level, able to perform all tests and had experienced light cognitive function failures that scored 18–23 on the MMSE. Exclusion criteria: diplegia, had never attended a school, were biased, or had received CACR within past year. Age: mean: CARC: 60.0 (SD 4.7) years; CG: 63.7 (SD 6.3) years Time since onset of stroke, mean: CARC: 5.3 (SD 2.3) months; CG: 6.0 (SD 2.2) months Types of stroke: hemiplegic only description provided Site of lesion: n (right/left hemisphere): CARC: 9/3; CG: 8/5 |
|
Interventions |
Intervention group Brief name: CARC using RehaCom software Recipients: adults with stroke within 3–12 months poststroke with cognitive dysfunction Why: to provide objective CT based on neuropsychological patterns to stimulate damaged location of the brain. What (materials): RehaCom software (Korean version): the awakening, reactivity, attention and concentration, simultaneous attention, and selective attention programs; see hasomed.de/en/products/rehacom/; the software is available in 27 languages at no extra cost; computer; joystick and touch screen input devices; optional reaction board. What (procedures): CACR in addition to occupational therapy and physical therapy Who provided: 2 "expert therapists" provided the CARC and traditional rehabilitation therapy. 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 and individually Where: not specified but within general hospital When and how much: 30 minutes per day, 5 days per week, for 6 weeks (total of 15 hours) (in addition to usual occupational therapy and physical therapy) Tailoring: feedback on the result during and after the treatment was provided and training occurred according to each participant's functional ability; the participants could complete the training using a reaction board while seated and watching the screen. Modifications: none reported in paper How well (planned): not reported How well (actual): not reported Comparator group Brief name: traditional rehabilitation therapy Recipients: adults with stroke with cognitive dysfunction Why: to provide rehabilitation services to people poststroke What: occupational therapy and physical therapy. Exercise was prescribed and supervised by 2 experienced physiotherapists Who provided: occupational therapists and physiotherapists How: face‐to‐face Where: 1 general hospital When and how much: 30 minutes 5 times per week for 6 weeks (total of 15 hours) Tailoring: none reported Modifications: not reported How well (planned): not reported How well (actual): not reported |
|
Outcomes |
Primary: none Secondary
Methods of data collection: the 4 tests were performed in order from the easiest to the hardest, and they were performed by everyone in the same order. Data collection time points: baseline and 6 weeks (post‐treatment) |
|
Notes |
Funding: not reported Conflict of interest: not reported Published trial protocol: not reported Trial registration: not reported Ethics approval: quote: "All of the protocols used in this study were approved by Gachon University. Before beginning the study, the procedures, risks and benefits were explained to all of the participants, who gave their informed consent". |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Only stated "randomly allocated" in the abstract. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | All participants signed a written consent form after receiving a full explanation of the expected result and adverse effects of the study. 2 expert therapists provided the CACR group and the CG with traditional rehabilitation therapy. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | A computerised neurocognitive function test was used to assess relevant cognitive outcomes, providing a level of objective assessment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported. |
Selective reporting (reporting bias) | Low risk | All outcomes in the methods were reported in the results. |
Other bias | Low risk | No other identifiable bias. |