Karner 2019.
| Study characteristics | ||
| Methods | RCT Setting: rehabilitation hospital, Germany | |
| Participants | Minimum age of 60 years and diagnosis of first stroke of the right hemisphere occurring within previous 3 months, with hemi‐neglect of the left side, ability to sit, no major cognitive impairment Age, years (SD): intervention = 74.21 (6.53), control = 73.34 (8.13) Sex (women/men): intervention = 10/11, control = 12/6 Hemisphere damaged: right Time since stroke, mean (SD), days: intervention = 49.24 (29.12), control = 55.17 (22.75) | |
| Interventions | Intervention group received treatment using a therapeutic stimulation robot. PARO is an interactive robot in the shape of a baby seal. Each treatment began with providing information to the patient. This was done verbally as well as by initial physical contact on the left upper arm: “I am now on the left side of your body, the side affected by your stroke” PARO was placed on the neglected side, so it was possible for the patient to see and grasp it. The task for the patient was focusing attention on the robot. As soon as the patient had fixed his or her attention on PARO, it was successively moved further to the neglected side Control group was classified as attention control, with the researcher giving physical contact to the patient on the arm with verbal information as per the intervention. A book was also given for the patient to see and grasp. The patient was then read aloud from the book |
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| Outcomes |
Participants were followed up for 2 weeks post intervention; therefore this does not meet our definition of 'persisting' effects of the intervention |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated |
| Allocation concealment (selection bias) | Unclear risk | Recruitment of study participants and assignment to study groups were carried out by the researcher |
| Blinding of participants | High risk | Not possible to blind |
| Blinding of personnel | High risk | Not possible to blind |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Attempted blinding of neuropsychologist for neglect measures and others for ADL |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Lost 8 (17%), but reasons given and not markedly different between groups |
| Selective reporting (reporting bias) | Low risk | Outcomes reported in adequate detail |
| Other bias | Low risk | Nothing obvious |