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Completed
NCT07768683
Stroke Upper Limb Rehabilitation With Robot Operators: a Synergistic Approach for Human-Robot Interaction and Rehabilitative Trials.
Conditions: Stroke
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 50
Sponsor: Villa Beretta Rehabilitation Center
Location: Villa Beretta Rehabilitation Center Costa Masnaga Italy
Summary
In clinical scenario, clinical scales and kinematic analysis are usually used for the evaluation of patients. However, these methods are limited, since they may suffer from the lack of objectivity and sensitivity. Synergies go beyond pure kinematics and allow to directly understand the neural mechanisms underlying the motor impairment. Synergy analysis has been exploited for understanding physiological mechanisms in healthy subjects, but only few studies analyzed muscle synergies on patients during rehabilitation. In order to translate this methodology to the clinical practice, there is the need of comprehensive and structured studies. However, only few pilot studies are available that analyzed synergies during rehabilitation. Thus, in this study we aimed at filling this gap by analyzing synergies during human-robot interaction when using an end-effector robot and an exoskeleton robot and by assessing in detail the modifications of synergies after robotic rehabilitation.
Eligibility Criteria
Inclusion criteria for healthy subjects
* Adult subjects (aged ≥18 years old)
* Non orthopaedic condition at upper limb
* No neurological or motor impairment Exclusion criteria for healthy subjects
* Physical conditions that can alter normal biomechanics
* Pregnant or nursing women
* No written informed consent
* Active implantable devices (e.g., pacemaker)
Inclusion criteria for post-stroke subjects
* Adult subjects (aged ≥18 years old)
* Subjects suffering from subacute and/or chronic stroke disability
* Coming from ischemic or hemorrhagic stroke
* With a level of motor impairment defined by a minimum residual motion corresponding to Motricity Index ≥ 39.
Exclusion criteria for post-stroke subjects
* Subjects with a high level of spasticity (Modified Ashworth Scale: In general \>3 except for motorized joints which may be \>2)
* Pain in the affected upper limb (Numeric Rating Scale \> 6)
* Severe psychiatric disorder
* Permanent neurologic symptoms present immediately before stroke
* Physical conditions that can alter normal biomechanics (e.g., recent sprains or injuries, etc.)
* Pregnant or nursing women
* No written informed consent from the patient or the legal representative
* Active implantable devices (e.g., pacemaker)
* Unstable medical condition
Source: ClinicalTrials.gov (NCT07768683). StuddyBuddy aggregates publicly available trial information.