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. 2022 Aug 5;2022(8):CD011887. doi: 10.1002/14651858.CD011887.pub3

Franceschini 2012.

Study characteristics
Methods Randomized controlled observer‐blind trial
Participants Eligible hemiparetic stroke survivors from 13 rehabilitation centers were recruited
Franceschini 2012 paper:
102 participants:

  1. 53 in experimental;

  2. 49 in 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:

  1. 33 in experimental;

  2. 34 in 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
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 minutes, daily (with 60‐minute interval), 5 days/week, for 4 consecutive weeks (in addition to 3 hours of standard rehabilitation)
Outcomes Franceschini 2012 paper:
Outcomes recorded at baseline, postintervention and at 4 to 5 months from treatment conclusion

  1. Upper limb motor function: Fugl‐Meyer Assessment ‐ upper limb items, Frenchay Arm Test, and Box and Blocks Test

  2. Muscle tone: Modified Ashworth Scale

  3. Functional Independence: Functional Independence Measure ‐ motor items


Sale 2014 paper:
Outcomes recorded at baseline, postintervention and at 4 to 5 months from treatment conclusion

  1. Upper limb motor function: Fugl‐Meyer Assessment ‐ upper limb items and Box and Block Test
Notes There are 2 publications for this study. The authors declared no potential conflicts of interest.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Central randomisation
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 postrandomization, 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 No other potential risk of bias was found.