Maggio 2020.
Study characteristics | ||
Methods |
Design: parallel RCT Duration of trial: 22/23 months (June 2017 to March 2019) Unit of randomisation: people affected by chronic stroke with mild‐to‐moderate cognitive impairment undergoing neurorehabilitation Recruitment and allocation: not reported in detail except that 40 people with a diagnosis of stroke who attended the Robotic and Behavioral Neurorehabilitation Unit of the IRCCS Centro Neurolesi "Bonino‐Pulejo" (Messina, Italy) from June 2017 to March 2019, were enrolled in this study and randomly divided into 2 groups: IG (n = 20); CG (n = 20). |
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Participants |
Setting: robotic and behavioural neurorehabilitation unit of a rehabilitation facility Country: Italy Sample size: 40 adults, 55% men, IG: 20; CG: 20 Inclusion criteria: first‐ever supratentorial stroke in the chronic phase (i.e. 6–12 months after the event); presence of mild‐to‐moderate cognitive impairment (MMSE: 11–26); absence of disabling sensory alterations (i.e. auditory and visual loss) Exclusion criteria: age > 85 years; presence of severe medical and psychiatric illness potentially interfering with the training Age: mean: 53.9 (SD 4.5) years Time since stroke onset: mean: 6 (SD 1) months Types of stroke and site of lesion: (n) cortical right: IG: 12; CG: 11; subcortical right: IG: 6; CG: 7; cortical left: IG: 2; CG: 2; subcortical left: 0 |
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Interventions |
Intervention group Brief name: HAT Recipients: adults with cognitive impairments after chronic stroke undergoing rehabilitation Why: to evaluate how people react and interact with this environment, and prepare them for a return home. What (materials): HAT within the home automation room (see Figure 1 of photo in original paper for example technologies in use). The room was designed for severely disabled people who were partially autonomous in their movements. Using a centralised control system, participants can change the environment, monitor some environmental parameters (e.g. detect the presence of smoke, water, or gas leaks), and use the alarm bell. Kitchen countertops and other shelves could be adapted in height and depth. The bathroom had an adaptable toilet and shower, which could be changed by the patient. What (procedures): small group functional activities in a home automation room with home automation or domotics technologies where the interaction was mediated by these technologies to achieve participant ADL goals, e.g. cooking and personal care in preparation for returning home. Who provided: a "therapist" – further specifics not provided; however, 1 of the authors was an occupational therapist and the intervention clearly falls within the scope of occupational therapy practice. How: face‐to‐face in a group (3–5 participants per group) Where: in a room with home automation or domotics technologies in neurorehabilitation unit When and how much: 3 sessions per week for 8 weeks (i.e. total of 24 sessions), each session lasting about 60 minutes (24 hours in total) Tailoring: the adjustability provided within the room allowed tailoring of heights and depths of equipment and technologies to suit participant's individual needs, disabilities, and dimensions. Modifications: none reported How well (planned): none reported How well (actual): none reported Comparator group Brief name: traditional training Recipients: adults with cognitive impairments after chronic stroke undergoing rehabilitation Why: to facilitate homecoming even for severely disabled people who are partially autonomous in their movements. Training allows the use of domestic environments (e.g. kitchens, bathrooms) with strategies that permit an effective use. What: therapist led the participant through a series of exercises promoting autonomy in daily life activities, including positioning of marbles, ball exercises, and manipulation of various objects such as buttons for fastening a jacket or zippers. Conventional training was based on direct interaction and exercises with the participants (often working together), who could also use paper/pencil exercises. Who provided: a "therapist" – further specifics not provided; however, 1 of the authors was an occupational therapist and the intervention clearly falls within scope of occupational therapy practice. How: face‐to‐face activities in small group (3–5 participants) Where: within rehabilitation unit but not further described When and how much: 3 sessions per week for 8 weeks (i.e. total of 24 sessions), each session lasting about 60 minutes (total of 24 hours) Tailoring: none reported Modifications: not reported How well (planned): not reported How well (actual): not reported |
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Outcomes |
Primary
Secondary
Other
Methods of data collection: each participant was evaluated by a neuropsychologist before (T0) and after the last training session (T1). Data collection time points: baseline and postintervention (8 weeks) |
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Notes |
Funding: no. Quote: "The authors received no financial support for the research, authorship, and/or publication of these authors". Conflict of interest: none Published trial protocol: none reported Trial registration: none reported Ethics approval: yes Data: medians and interquartile ranges 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 | By tossing a coin. |
Allocation concealment (selection bias) | Unclear risk | No indication if coin tossing was done independently. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Incomplete blinding. Therapists were blind to the assignment and objectives of the study; however, it may have been possible for therapists to discern which therapy a participant was receiving and for participants to know to which group they were allocated. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The testers were blind to the assignment and objectives of the study, but it is unclear if ADL and IADL was assessed by a tester or participant self‐report. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The paper stated that all participants completed the intervention and it was likely that all were assessed. |
Selective reporting (reporting bias) | Low risk | No protocol reported but appears that all planned outcomes were reported. |
Other bias | Low risk | No other identifiable bias. |