💬In plain words
What the trial is, and whether it could suit you
Study procedures: After acquiring clinical-demographic, neurophysiological and clinical-functional data to describe the extent of upper limb impairment at baseline at the facilities of the Rehabilitation Medicine Unit (UMR) of the Ferrara University Hospital (Department of Neuroscience), patients will undergo a 10-day home rehabilitation programme (two consecutive weeks, five days a week, two daily sessions of one hour each) with remote supervision by study staff in a randomised manner in two groups:
* Experimental group: patients in this group will perform the exercises at at home with the paretic upper limb wearing the orthosis, © Aurafix, model ORT-07A, characterised by elastic bands that exert resistance on the distal phalanx of the fingers.
* Control group: patients in this group will perform the exercises at home with the paretic upper limb wearing the orthosis (in order to stabil
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Males and females aged 18 years or older;
* Diagnosis of first cerebral stroke (ischaemic or haemorrhagic) in the chronic phase (i.e. at least 6 months after the onset of the acute event) verified by brain imaging (brain computed tomography and/or magnetic resonance imaging);
* Motor deficit in the upper limb - and in particular in the hand - caused by stroke, not attributable to other conditions or diseases and not such as to preclude the ability to perform movements with the fingers and to perform movements to grasp objects;
* Ability to express informed consent correctly.
* Availability of a webcam and Internet connection at home for remote supervision of activities by the staff involved in the study.
Exclusion Criteria:
* Medical conditions that may interfere with the ability to safely complete the study protocol;
* Cognitive dysfunction that precludes informed consent;
* Severe neuropsychological disorders;
* Severe visual problems;
* Upper limb pain assessed with Visual Analogue Scale (VAS) \> 7;
* Severe internal diseases (e.g. cardiopulmonary, renal, hepatic);
* Diseases with inflammatory skin lesions, wounds, sensory and circulatory disorders below the elbow and on the hand in the area of application;
* Contraindications to transcranial magnetic stimulation (TMS) procedures, assessed as indicated by international reference, such as: presence of intracranial metal implants, positive history of epilepsy, frequent migraines, implantable devices (ventricular-peritoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants). It should be noted that the presence of this type of exclusion criterion will preclude the performance of TMS assessments, but not the remaining procedures of the study;
* Pregnancy.
💊
What it tests
- Dynamic perturbation-based intervention
- Exercises without dynamic perturbations
Ferrara University Hospital
Ferrara, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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