Zuchella 2014.

Study characteristics
Methods	Design: parallel RCT Duration of trial: 31 months (1 June 2010 to 31 December 2012) Unit of randomisation: inpatients with first‐ever stroke and confirmed cognitive deficits Recruitment and allocation: of 288 people consecutively referred, 196 were excluded, leaving 92 who were randomised by random number generator to 2 groups, IG (n = 45) and CG (n = 47); 2 participants from each group did not receive the allocated intervention due to worsening clinical conditions and 1 from the study group had poor compliance, leaving 42 participants in IG and 45 in CG.
Participants	Setting: neurorehabilitation unit Country: Italy Sample: 92 participants randomised, 87 adults reported and analysed, 53% men; IG: 42; CG: 45 Inclusion criteria: first‐ever stroke within previous 4 weeks, aged 45–80 years, MMSE score > 10, cognitive deficits defined as test scores below population‐based norms on ≥ 3 neuropsychological tests Exclusion criteria: progressing stroke, neglect, aphasia, additional neuropsychological or psychiatric disorders, depression (> 7 on Hamilton Depression Rating Scale), premorbid IQ < 70 or pre‐existing dementia, visual deficits, motor impairment liable to affect performance on tests Age: median (quartiles): IG: 64 (25th 56.2; 75th 74.2) years; CG: 70 (25th 62.5; 75th 76.5) years Time for admission: median (quartiles): IG: 11.5 (25th 10; 75th 14) days; CG: 11 (25th 9; 75th 14) days Types of stroke: ischaemic: n: IG: 31 (73.8%); CG: 34 (75.6%) Site of lesion: n: IG: right 18 (43%), left 12 (29%), brain stem 8 (19%), cerebellum 3 (7%), bilateral 1 (2%); CG: right 27 (60%), left 14 (31%), brain stem 3 (7%), bilateral 1 (2%) NIHSS stroke severity score: median (quartiles): IG: 15 (25th 14; 75th 17); CG: 15 (25th 13; 75th 15.2)
Interventions	Intervention group Brief name: CT Recipients: inpatients with first‐ever stroke and confirmed cognitive deficits Why: to provide early comprehensive cognitive rehabilitation combining computer training and metacognitive strategies. What (materials): computer and 2 software programs (in Italian): "Una palestra per la mente" (Gollin 2011); see A Gym for the Mind 2 for the English version and a description in English a gym for the mind 2 (KIT: Book + CD‐ROM) New exercises of cognitive stimulation for brain aging and dementia. 300 activities for temporal and spatial orientation, visual attention, memory, language, and logic; "Training di riabilitazione cognitiva" (Powell 2009) See www.erickson.it/it/training-di-riabilitazione-cognitiva training of cognitive rehabilitation (KIT: Book + CD‐ROM) Exercises of memory, thinking skills and executive functions after brain injury. The website states that the activities were also printable What (procedures): in addition to usual rehabilitation care, including medications and physiotherapy, individual sessions performing activities using the software addressing the following cognitive domains: time orientation: days of week, months of year, seasons, holidays, and celebrations; anagrams of days of week, months, and seasons; identification of temporal sequences within a story or in the execution of ADL; temporal sequences with images relating to ADL; spatial orientation: recognition of right and left; recognition and identification of cities, regions; word search puzzles; positions of objects; observation of scenes and identification of the position of objects; orienteering skills following pathways; visual attention: searching for targets among distractors (stylised elements of objects); word search puzzles; findings the differences between images/scenes; searching for elements by categories; logical reasoning: calculation; words in context; searching for intruders within categories; logical completion (metaphors and proverbs); categorisation; memory: recognition of pairs of words with or without logical connections; remembering lists; face recognition; memorisation of scenes and stories then answering a questionnaire; object location and object seeking (e.g. memory game with cards); executive functions; answering questions about a story; identifying the purpose/meaning of a story; following pathways subject to certain rules; recognition of moods; mathematical logic; action planning; re‐ordering the sequence of a story; critical judgement (giving the pros and cons of ethical and social topics); problem‐solving. While the participants performed the activities the psychologist suggested metacognitive strategies to them to develop their awareness and self‐regulation, e.g. the participant was asked to predict results on tasks and identify factors that were contributing to their successes and failures. In last 15 minutes of session, the psychologist reasoned with participants about any problems encountered, explaining how to transfer the learned strategies to everyday situations to foster their generalisation to real‐world tasks (e.g. participants were encouraged to adopt 'associative techniques' and to use their imagination to improve their memory. Who provided: 2 psychologists, experts in neuropsychology, provided the sessions; the website states that the activities can be administered by professionals or family caregivers and refers to "rehabilitation therapists" using features to track progress How: apparently individually and face‐to‐face Where: neurorehabilitation unit; website states activities can be performed at home When and how much: 4 × 1‐hour sessions per week over 4 weeks (16 hours in total) Tailoring: 3 levels of difficulty; progress occurred to the next level when 70% correct response rate achieved; if the participant failed an activity 3 times, the presentation was simplified and made more understandable through examples. Website states that the activities can be expanded and modified to suit the particular needs of the person and that the instructions can be heard or written. Modifications: not reported How well (planned): to ensure inter‐therapist reliability and to ensure that participants received the same guidance during the training sessions, the psychologists followed written instructions and examples defined during the drafting of the protocol. How well (actual): not reported Comparator group Brief name: usual care (plus sessions with psychologist) Recipients: inpatients with first‐ever stroke and confirmed cognitive deficits Why: to provide usual care and equivalent sessions with a psychologist. What (materials): general topics, news, and participants' recent activities for general discussion What (procedures): the participants spent the same amount of time with a psychologist, discussing general topics, news, and their recent activities and usual rehabilitation care (medications, physiotherapy) Who provided: psychologist and other providers, e.g. medical and physical therapists How: individual, face‐to‐face Where: neurorehabilitation unit When and how much: 16 hours of individual training, divided into 1‐hour sessions spread over 4 weeks (4 sessions per week) Tailoring: none reported Modifications: not reported How well (planned): not reported How well (actual): not reported
Outcomes	Primary FIM Secondary MMSE Digit Span Corsi's Test RAVLT Raven's Colored Progressive Matrices (PM47) FAB TMT‐A TMT‐B Attentive Matrices Other ReyOsterrieth Complex Figure, copy Phonological verbal and semantic verbal fluency Aphasia test HDRS Methods of data collection: functional evaluation using the FIM on admission and after intervention, neuropsychological assessment performed within first week of admission before randomisation and after intervention. All assessments performed by a psychologist blind to the randomization and not involved in their care. Data collection time points: baseline and after 4 weeks of intervention
Notes	Funding: not reported Conflict of interest: none Published trial protocol: no Trial registration: no Ethics approval: yes Data: median and interquartile ranges converted to means and SDs
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "… patients who met the inclusion criteria were enrolled in the study and randomly assigned to the study group (SG) [IG] or to the control group (CG) by means of a computer random number generator".
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	The authors reported that the CG received a sham intervention but the difference between the nature of the intervention (cognitive rehabilitation with a therapist leading them through computer activities) and control (discussion with therapist) would still be possible for participants to discern. Similarly, therapists were not blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "All the assessments were done by a psychologist blind to the patients' randomization and not involved in their care".
Incomplete outcome data (attrition bias) All outcomes	Low risk	Flow chart showed the numbers missing (IG: 3; CG: 2) and who did not receive allocated intervention and not included in analysis.
Selective reporting (reporting bias)	Low risk	All relevant outcomes from method reported.
Other bias	Low risk	No other identifiable bias.

ACCPT: Auditory Controlled Continuous Performance Test; ADL: activities of daily living; AMPS: Assessment of Motor and Process Skills; APT: Attention Process Training; BADL: basic activities of daily living; BADS: Behavioural Assessment of Dysexecutive Syndrome; BNIS: Barrow Neurological Institute Screen for Higher Cerebral Functions; CACR: computer‐assisted cognitive rehabilitation; CCR: computer cognitive rehabilitation; CFQ: Cognitive Failures Questionnaire; CI: confidence interval; CO‐OP: Cognitive Orientation to Occupational Performance; COPM: Canadian Occupational Performance Measure; CT: cognitive training; CWIT‐3: Color Word Interference Test – Inhibition (Condition 3); CWIT 4: Colour Word Interference Test – Inhibition/Switching (Condition 4); DEX: Dysexecutive Questionnaire; DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders – 4th Edition; DST: Digit Span Test; FAB: Frontal Assessment Battery; FIM: Functional Independence Measure; FIS: Fatigue Impact Scale; FSAQ: Full‐Scale Attention Quotient; GHQ‐28: 28‐item General Health Questionnaire; HADS: Hospital Anxiety and Depression Scale; HAT: home automation training; HDRS: Hamilton Rating Scale for Depression; IADL: instrumental activities of daily living; IQ: intelligence quotient; IVA‐CPT: Integrated Visual Auditory Continuous Performance Test; LOTCA: Lowenstein Occupational Therapy Cognitive Assessment; MoCA: Montreal Cognitive Assessment; MMSE: Mini‐mental State Examination; mRS: modified Rankin Scale; MVPT‐3: Motor‐free Visual Perception Test‐3; N/n: number of participants; NFB: neurofeedback; NIHSS: National Institutes of Health Stroke Scale; PASAT: Paced Auditory Serial Addition Test; PE: physical exercise; RAVLT: Rey Auditory Verbal Learning Test; RBMT‐II: Rivermead Behavioural Memory Test‐II; RCT: randomised controlled trial; SASS: Social Adaptation Self‐evaluation Scale; SC: standard care; SD: standard deviation; SEM: standard error of the mean; SF‐36 MCS: Medical Outcomes Study 36‐item Short‐Form – Mental Component Score; SF‐36 PCS: Medical Outcomes Study 36‐item Short‐Form – Physical Component Score; SS‐QOL: stroke‐specific quality of life; TBI: traumatic brain injury; TENS: transcutaneous electrical nerve stimulation; TMT‐A: Trail Making Test A; TMT‐B: Trail Making Test B; USER‐P: Utrecht Scale for Evaluation of Rehabilitation‐Participation; VCPT: Visual Continuous Performance Test; VST: Visual Span test; WAIS‐III: Wechsler Adult Intelligence Scale III; WAIS‐III‐NI: Wechsler Adult Intelligence Scale III Neuropsychological Instrument; WM: working memory.