Franceschini 2012.
Methods | Randomized controlled observer‐blind trial | |
Participants | Eligible hemiparetic stroke survivors from 13 rehabilitation centers were recruited Franceschini 2012 paper: 102 participants: 53 experimental, 49 control Inclusion criteria: participants with first‐ever stroke, enrolled 30 days (±7) after the event onset with ischemia or primary hemorrhage, right‐handed prior to stroke Exclusion criteria: posterior circulation infarction, subarachnoid hemorrhage, severe forms of neglect and anosognosia (number of errors in Bell Barrage test ≥ 15), impaired comprehension (Token test score ≤ 17), history of endogenous depression or serious psychiatric disorders, and severe visual deficits (restricting the access to visual stimuli) Mean (SD) age: experimental group: 67.0 (12.4) years; control group: 65.7 (11.9) years Stroke details: etiology ‒ control group: 9 hemorrhagic, 40 ischemic; experimental group: 16 hemorrhagic, 37 ischemic. Lesion side: control group: 18 right, 24 left; experimental group: 22 right, 26 left Stroke phase: acute Sale 2014 paper: 67 participants: 33 experimental, 34 control Inclusion criteria: moderate to severe upper limb paresis, first‐ever ischemic stroke, 30 days (±7) after the event, right handed prior to stroke, unilateral brain lesions Exclusion criteria: posterior circulation infarction, subarachnoid hemorrhage, severe forms of neglect and anosognosia, impaired comprehension or dementia, history of endogenous depression or serious psychiatric disorders, severe visual deficits, bilateral motor impairment, severe sensory deficits in the paretic upper limb, refusal or inability to provide informed consent, other concomitant severe medical problems Mean (SD) age: 66.5 (12.7) years Stroke details: ischemic Stroke phase: acute |
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Interventions | Experimental group: observation of 1 daily routine task (actions) carried out with the upper limb, each action consisted of 3 different meaningful motor sequences (3 minutes each). After observing the video, the participant should perform, with their paretic upper limb, the same movement (2 minutes each), with help when needed Control intervention: observation of 5 static images displaying objects, without any animal or human being (different 3‐minute sequences). Then, the participants had to perform limb movements for 2 minutes according to a standard sequence, simulating those performed by the other group Sessions were 2 × 15 minute, daily (with 60‐minute interval), 5 days/week, for 4 consecutive weeks (in addition to 3 hours of standard rehabilitation) |
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Outcomes | Franceschini 2012 paper: Outcomes recorded at baseline, post‐intervention and at 4 to 5 months from treatment conclusion Upper limb motor function: FMA‐ upper limb items, FAT, BBT Muscle tone: MAS Functional Independence: FIM‐ motor items Sale 2014 paper: Outcomes recorded at baseline, post‐intervention and at 4 to 5 months from treatment conclusion Upper limb motor function: FMA‐ upper limb items and BBT |
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Notes | There are 2 publications for this study | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Central randomization |
Allocation concealment (selection bias) | Low risk | Participants and investigators enrolling participants could not foresee assignment because central allocation was used to conceal allocation |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | No blinding, but the outcome is not likely to be influenced by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All assessments were performed by trained professional not involved in the research treatment and blind to group allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | 12 participants were excluded post‐randomization, 5 from experimental group and 7 from control group. Reasons were not reported. There was an imbalance of 6 participants in final number of participants in each group considered for analysis |
Selective reporting (reporting bias) | Low risk | There is no trial registration, but the outcomes are significant, and there is no selective reporting within the study |
Other bias | Low risk |