Prokopenko 2018.
Study characteristics | ||
Methods |
Design: parallel RCT (note: data only for 2 groups included in this review: IG and passive CG) Duration of trial: not reported Unit of randomisation: participants aged 40–67 years, with vascular cognitive impairments without dementia in early recovery periods of ischaemic hemispheric stroke (up to 6 months after stroke) Recruitment and allocation: not reported in detail; 25 participants receiving conventional treatment in the Neurorehabilitation Center were randomised into 3 groups: IG (n = 10), passive CG (n = 9), and active CG (n = 6); data only for the intervention and passive CG were used in this review. |
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Participants |
Setting: neurorehabilitation centre Country: Russia Sample size: 19 adults, 72% men; IG: 10; passive CG: 9 Exclusion criteria: decompensation of somatic and neurological diseases; epilepsy; severe cognitive dysfunction; severe and moderate aphasia; and severe decrease of vision or hearing Age: median (quantiles): IG: 59.5 (1st 57; 3rd 60) years; CG: 62.55 (1st 61; 3rd 65) years Time since stroke onset: not reported except recruited up to 6 months after stroke Types of stroke: ischaemic hemispheric stroke Side of lesion: not reported |
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Interventions |
Intervention group Brief name: computer CT Recipients: people with vascular cognitive impairments without dementia in early recovery periods of ischaemic hemispheric stroke Why: to correct poststroke cognitive impairments in acute and early recovery periods based on the "classical neuropsychological approach of Alexander Luria". What (materials): KrasSMU complex of neuropsychological software programs for cognitive correction (in Russian); the software is reportedly available on CD, and online; includes programs for training:
What (procedures): an instructor demonstrated how to use a computer and explained the tasks and rules for each training program in the first few sessions then participants could train independently, remaining under the supervision of the instructor. Procedures for Figure‐Background test and Visual and Position test described in depth:
Who provided: not clearly stated in paper; however, the authors confirmed in personal correspondence about the same intervention provided in Prokopenko 2013 that the sessions were conducted by occupational therapists. How: individual face‐to‐face training using computer software programs; an instructor demonstrated how to use a computer and explained the tasks and rules for each training program during the first few sessions, then participants could train independently, while under the supervision of the instructor. Where: in a neurorehabilitation centre; also stated that participants could use the programs online. When and how much: 10 daily sessions for 30–40 minutes (5 hours to 6 hours 40 minutes in total) Tailoring: supervision was provided throughout so that individual support could be provided as needed. Levels of complexity could be increased depending on participants' abilities. Modifications: none reported How well (planned): none reported How well (actual): none reported Comparator group Brief name: conventional treatment Recipients: people with vascular cognitive impairments without dementia in early recovery periods of ischaemic hemispheric stroke Why: to provide conventional rehabilitation What: physiotherapy and drug treatment without any cognitive rehabilitation Who provided: neurorehabilitation centre staff How: not described but presumably face‐to‐face Where: not described but presumably in the neurorehabilitation unit When and how much: not reported Tailoring: none 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: evaluation of the participants' neurological, cognitive, affective, and functional states was performed before and after the observational period (the first examination during the first/second days on admission, and the second examination on the day after the last day of training). Data collection time points: before and after intervention (baseline and 10 days) |
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Notes |
Funding: not reported Conflict of interest: not reported Published trial protocol: not reported Trial registration: not reported Ethics approval: yes Data: median (1st, 3rd quantiles) converted to means and SDs |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A simple randomization using simple random tables was performed". |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported but apparent that participants could have known to which group they were allocated. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. |
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 all planned outcomes were reported except data for Clinicians Global Impression Scale and Patient's Global Impression Scale was not provided, which is not of interest to this review. |
Other bias | Low risk | No other identifiable bias. |