Efficacy of a Bilateral Robotic Treatment in Chronic Patients
ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Pisa
About this trial
The goal of this clinical trial is to evaluate how manual dominance influences the effectiveness of bilateral robotic treatment in right-handed patients with chronic stroke.
Researchers will compare the outcome of a bilateral robotic treatment for the upper limbs in left vs right hemisphere lesions following stroke.
Participants will:
* perform a bilateral robotic treatment for the upper limb (15 sessions in three weeks) followed by 20-minutes standard manual rehabilitative sessions * be evaluated before and after treatment with clinical scales, resting- state EEG and kinematic measurements
Eligibility criteria
Qualifiers
Subjects aged between 18 and 80 years, of either sex
Subjects able to understand and provide, or have provided on their behalf, informed consent
History of a single unilateral ischemic or hemorrhagic cerebrovascular event in the chronic phase (> 6 months)
Subjects with mild to moderate functional impairment of the right or left upper limb (ability to perform antigravity active movements)
Disqualifiers
Subjects with cognitive deficits that impair understanding of the required tasks (MMSE score corrected for age and education < 24/30)
Subjects with severe visual deficits
Subjects with upper limb spasticity preventing the use of robotic devices (spasticity measured using the Modified Ashworth Scale > 3)
Inability or unwillingness to provide informed consent
Trial design
Treatments tested in this trial
- Bilateral robotic treatment for the upper limbs
- Standard physiotherapy
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
University of Pisa
Lead sponsor
Azienda Ospedaliero, Universitaria Pisana
Collaborator
Villa Beretta Rehabilitation Center
Collaborator
Fondazione Don Carlo Gnocchi Onlus
Collaborator
Ospedale Policlinico San Martino
Collaborator
Source ClinicalTrials.gov