Mancuso 2021.
Study characteristics | ||
Methods | Randomized clinical trial | |
Participants | Acute stroke patients (at a maximum of 30 days from onset) clinically evaluated by a neurologist and that underwent a CT brain scan 32 participants:
Inclusion criteria: both genders, any education level, aged from 18 to 90 years old, first‐ever stroke, unilateral cerebral lesion, upper limb impairment, and at a maximum of 30 days from onset, and ability to understand spoken language (Token Test score higher than 8) Exclusion criteria: subarachnoid hemorrhage, severe neglect at the Star Cancellation from the Behavioural Inattention Test (a score lower than 51), impaired comprehension (a score lower than 8 in the Token Test), ideomotor apraxia, cognitive decline (a score lower than 23.8 in the Mini Mental State Examination), history of endogenous depression or severe psychiatric disorders for which patients needed chronic pharmacotherapy, or severe visual deficits (eye field examination of the National Institutes of Health Stroke Scale) Median (IQR) age: experimental group: 76.5 (13.7) years, control group: 64.5 (15.75) Stroke details: Hemiparesis: experimental group: 7 right and 9 left; control group: 8 right and 8 left Stroke phase: acute |
|
Interventions |
Experimental group: conventional therapy (60 minutes ‐ training for transfers, mobility, walking up and down steps, balance tasks, tailored functional tasks for the upper limbs (unimanual and bimanual), joint and soft tissue mobilization, and specific sensory stimulation) + AO (30 minutes). Participants were asked to carefully observe the videos for 3 minutes in order to prepare themselves to imitate the presented action. At the end of each sequence, participants performed the same movement with the paretic upper limb over a time period of 2 minutes. 3 minutes of sequence observation and 2 minutes of action performance for 3 motor sequences, repeated twice Control group: conventional therapy (60 minutes) + task oriented therapy (30 minutes). Participants performed functional activities with the upper limbs, using the same objects as AO, in both unimanual and bimanual modalities, without watching the video beforehand In both groups, each session was 190 minutes (60 minutes of conventional treatment + 30 minutes of AO or task oriented training), 5 days per week, for 4 weeks |
|
Outcomes | Outcomes recorded at baseline and postintervention
|
|
Notes | The authors declared no potential conflicts of interest. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A computer‐generated random number was used to allocate participants arbitrarily to the AO training group or the control group. |
Allocation concealment (selection bias) | Low risk | The randomisation procedure and assignment were managed by an independent researcher who was not involved in the evaluation of the participants. |
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 researchers not involved in the treatment administration and blinded to the patient’s allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts were recorded during the treatment, and all participants fulfilled the protocol. |
Selective reporting (reporting bias) | Low risk | The study was registered on ClinicalTrials.gov, with the number NCT04604171. Registry contains all reported outcomes |
Other bias | Low risk | No other potential risk of bias was found. |