Istituti Clinici Scientifici Maugeri IRCCS
Pavia, 27100, Italy
NCT Number: NCT03738813
Stroke is one of the leading causes of death and disability and has been described as a worldwide epidemic (1). Stroke survivors are affected by impairments and limitations of cognitive, language, perceptual, sensory, and motor functions. After a stroke, patients can improve spontaneously within the first 3 months (2) and then more slowly in the following year. The first day, decreased oedema and partial reperfusion of the ischemic penumbra may possibly explain these phenomena, but the improvement of neurological deficit in the following weeks suggests plasticity phenomena and brain cortical reorganization (3). While most recovery is thought to be made in the first few weeks after stroke, patients may make improvements on functional tasks many months after having a stroke (4). Restoring arm and hand skill after a stroke remains challenging, even though stroke rehabilitation programs have proven partial efficacy Repetitive task training has been shown to be effective in some aspects of rehabilitation, such as improving walking distance and speed and improving upper limb function (5).
In this project, the investigators will use "Gloreha ARIA" (7) a new sensor-based therapy device designed for motor recovery of impaired upper limb Gloreha Aria offers specific programs that help patients to move arm, wrist and fingers. Therapists can customize therapy by focusing on a specific motor task.
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Interventional
Not applicable
Pavia, 27100, Italy
The hypothesis was that rehabilitation with this device could be not inferior in comparison with hands-on physiotherapy, in the reeducation of upper arm in the patient affected by stroke from cerebral ischemia or hemorrhage that had occurred ≤ 30 days before.
The principle purpose of this study will be to evaluate:
Post-stroke patients admitted for inpatient rehabilitation to the Neurological Rehabilitation will be screened for enrolment and randomized in a controlled trial.
All the patients will be informed about the aim and experimental procedures before enrolment, thus written informed consent will be obtained from all of them. Patients included in the study will be randomly assigned to intervention or control group according to simple randomization technique (computerized random numbers).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Device offers specific programs that help patients to move arm, wrist and fingers
Conventional occupational therapy
Time frame: From date of randomization (T0) until the to the end of the study (T1) after an intervention lasting over a period of about 6 weeks, assessed after 30 rehabilitation sessions, lasting 30 min/ day each and performed 5 days/week.
Assessment of sensorimotor function.
Istituti Clinici Scientifici Maugeri SpA
Other
Feasibility and Efficacy of the Upper Limb Treatment With "Gloreha Aria" in the Hemiplegic Patients: a Randomized Pilot Study
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