De Luca 2018.
Study characteristics | ||
Methods |
Design: single‐blind RCT Duration of trial: 2 years and 4 months (January 2013 to May 2015) Unit of randomisation: adults receiving rehabilitation with ischaemic or haemorrhagic stroke in the chronic phase (3–6 months after acute neurological event). Recruitment and allocation: people diagnosed to need cognitive rehabilitation were enrolled and assigned in order of recruiting to intervention group of CCR (IG) (n = 20) or traditional cognitive rehabilitation (CG) (n = 15). |
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Participants |
Setting: cognitive rehabilitation institute Country: Italy Sample size: 35 adults; 51.4% men; IG: 20; CG: 15 Inclusion criteria: diagnosis of vascular brain injury of either haemorrhagic or ischaemic aetiology (the latter involving the middle cerebral artery); presence of moderate cognitive impairment, i.e. MMSE score 12–20; absence of severe spasticity with an Ashworth Scale < 3; absence of disabling sensory alterations (i.e. hearing and visual loss), and severe medical and psychiatric illness according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition and International Classification of Diseases‐10. Exclusion criteria: severe spasticity; disabling sensory alterations, e.g. hearing and visual loss, severe medical and psychiatric illness Age: mean: 43.1 (SD 16.8) years Time since onset of stroke: mean: 3.5 (SD 2.0) months Types of stroke: ischaemic: 24; haemorrhagic: 11 Site of lesion: n: cortical right: 11; subcortical right: 10; cortical left: 8; subcortical left: 6 |
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Interventions |
Intervention group Brief name: ERICA PC training Recipients: adults with chronic phase of stroke (3–6 months) Why: to implement CT in 5 cognitive domains of attention process, memory abilities, spatial cognition, and verbal and non‐verbal executive functions. What (materials): computer‐based ERICA software training (www.erica.giuntios.it/it/) in Italian; personal computer What (procedures): traditional cognitive rehabilitation plus computer‐based ERICA software training provided by a therapist who provided exercises with a growing hierarchy of complexity. Who provided: a trained cognitive therapist; the ERICA website states that professionals who can use ERICA include: doctors with specialisation in geriatrics, physical medicine and rehabilitation, neurology and neuropsychiatry, psychologists, speech therapists, physiotherapists, occupational therapists. How: face‐to‐face and individually Where: not specified but within the rehabilitation institute When and how much: 24 sessions of 45 minutes each, 3 times per week for 8 weeks (total of 18 hours) in addition to traditional cognitive rehabilitation of 24 sessions 3 times per week for 8 weeks (for total of 48 sessions of 45 minutes each, total of 36 hours) Tailoring: the therapist provided the programmes within the "growing hierarchy of complexity" through the Erica platform; the difficulty of the exercises "was flexible to the progressive changes of the patient's performance and consistently ensure(d) effective and pleasant rehabilitation sessions". The website states: "The user [rehabilitation professional] selects the exercise to be administered, sets the parameters (target stimulus, exposure time, background color, etc.), administers the exercise and proceeds with the session". Modifications: none reported How well (planned): not reported How well (actual): not reported Comparator group Brief name: cognitive rehabilitation Recipients: adults with stroke Why: to stimulate specific cognitive skills and improve cognitive functional recovery poststroke What: CT using pen‐and‐paper tasks Who provided: a therapist How: face‐to‐face Where: in a rehabilitation institute When and how much: 45‐minute sessions 6 times per week for 8 weeks Tailoring: customised for participants' needs Modifications: not reported How well (planned): not reported How well (actual): not reported |
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Outcomes |
Primary (results not reported)
Secondary
Other
Methods of data collection: reported that each patient "was submitted to a complete neuropsychological evaluation before and after the treatment" to measure the cognitive domains (secondary outcomes in this review) and that the functional scales, BADL and IADL, Levels of Cognitive Functioning, and Barthel Index, were filled with the help of caregivers. The authors stated that it was a single‐blind study but did not report clearly who was blinded and if it was for this outcome assessment. Data collection time points: before and after treatment (8 weeks) |
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Notes |
Funding: authors reported no financial support was received for study. Conflict of interest: authors reported no conflicts of interest. Published trial protocol: none located Trial registration: none reported nor located 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 assigned to 1 of 2 groups "in order of recruiting". Unclear if this is describing alternate sequence generation or not. |
Allocation concealment (selection bias) | Unclear risk | The authors did not describe any procedure of allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "A trained cognitive therapist provided exercises with a growing hierarchy of complexity through the Erica rehabilitative platform". Both the treatment provider and participants were assumed to be aware of their group of intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Reported that each patient "was submitted to a complete neuropsychological evaluation before and after the treatment" to measure the cognitive domains of interest to this review and that it was a single‐blind study but did not report clearly who was blinded in the study and if it was for this outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported. |
Selective reporting (reporting bias) | High risk | ADL described as an outcome but not reported in the results. |
Other bias | Low risk | No other identifiable bias. |