Park 2015a.
Study characteristics | ||
Methods |
Design: parallel RCT Duration of trial: 6 months (October 2013 to March 2014) Unit of randomisation: adult inpatients with cognitive impairment after stroke Recruitment and allocation: of 37 inpatients recruited and screened, 30 were eligible and randomised by random numbers table into IG (n = 15) or CG (n = 15). |
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Participants |
Setting: rehabilitation hospital Country: Korea Sample size: 30 adults, 47% men; IG: 15; CG: 15 Inclusion criteria: history of 1 stroke; stroke with onset duration of < 3 months; score of ≤ 23 on the Korean version of MMSE; ability to understand instructions; ability to use the controller with the unaffected upper limb; and without unilateral hemispatial neglect and hemianopsia Age: mean: IG: 64.7 (SD 8.9) years; CG: 65.2 (SD 8.0) years Time since stroke onset: mean: IG: 1.5 (SD 0.5) months; CG: 1.8 (SD 0.6) months Types of stroke and lesion: not reported |
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Interventions |
Intervention group Brief name: CoTras Recipients: adult inpatients with stroke undergoing rehabilitation within 3 months' onset with cognitive impairment Why: to provide a Korean computer‐based cognitive rehabilitation to enhance attention, concentration, implementation skills, and perception‐motor skills. What (materials): CoTras program (Netblue Co., Ltd, Korea) computerised cognitive rehabilitation training, made for Koreans; a joystick and a large button on the CoTras panel which make the training easier for people who are unfamiliar with computer use; see www.netblue.co.kr/eng/doc/product01-01.php What (procedures): during the sessions, all participants completed a standard rehabilitation programme according to a daily inpatient treatment schedule. In addition to standard rehabilitation, all participants received 30‐minute daily sessions of the computer‐based program treatment. Who provided: not reported; however, the research was conducted by occupational therapists, the software is commercially available, and the intervention is within the scope of practice defined in the review. How: unclear but appeared it was face‐to‐face and individually. Where: local inpatient rehabilitation hospital, no further details provided When and how much: 20 × 30‐minute sessions (i.e. 5 days per week for 4 weeks) (10 hours in total) Tailoring: training allowed adjusting to individual participant's abilities at all levels of the programme Modifications: none reported How well (planned): none reported How well (actual): none reported Comparator group Brief name: conventional cognitive rehabilitation Recipients: inpatient with stroke with cognitive impairment undergoing rehabilitation Why: to provide usual rehabilitation services. What: pencil and paper with emphasis on visual perception ability Who provided: not reported How: not reported, assumed face‐to‐face Where: inpatient rehabilitation hospital When and how much: matched that for the IG participants in terms of duration (in minutes) (i.e. 20 × 30‐minute sessions) Tailoring: not reported Modifications: not reported How well (planned): not reported How well (actual): not reported |
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Outcomes |
Primary: none Secondary
Other
Methods of data collection: all outcome measures were administered to the participants by the assistant researcher with 5 years' experience in using the measures. Data collection time points: baseline and 4 weeks postintervention |
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Notes |
Funding: none stated Conflict of interest: none reported Published trial protocol: none located Trial registration: none reported Ethics approval: unclear, stated, "All subjects provided written informed consent before study inclusion according to the code of ethics of the World Medical Association (Declaration of Helsinki, version 2004)". |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers table used to randomly assign participants to either CG or IG. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Quote: "All subjects gave their voluntary consent to participate after receiving a detailed explanation of the purpose and methods of the study" and "During the sessions, all subjects participated in a standard rehabilitation program according to a daily inpatient treatment schedule. In addition to standard rehabilitation, all subjects received 30‐min daily sessions of either the CG or the EG [IG] treatment". Comment: highly likely that participants and personnel knew which group they were in. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "All outcome measures were administered to the patients at baseline and at the end of treatment (after the 4‐week intervention) by the assistant researcher with 5 years' experience in using the measures". Comment: unclear whether this person was blinded to the allocation. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Study did not address this criterion. |
Selective reporting (reporting bias) | Low risk | No protocol located but appeared to report all outcomes and data. |
Other bias | Low risk | No other identifiable bias. |