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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Bilateral robotic treatment for the upper limbs
DevicePatients will perform a specific sequence of exercises with the exoskeleton for the upper limbs ALEx-RS, including passive and active-assisted movements, unilateral and bilateral reaching tasks with visual feedback, and symmetric and asymmetric bimanual coordination tasks.
Standard physiotherapy
BehavioralAfter the robotic treatment, patients will undergo 20 minutes of conventional treatment consisting of passive and active-assisted mobilization with the help of a physiotherapist.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Left hemisphere lesion groupExperimental treatment 2 interventions
Group B: Right hemisphere lesion groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Changes in the Fugl-Meyer for the upper limb functional scale (UEFM)
The scale ranges from 0 to 66, with higher scores indicating better performance
Time frame
From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0Secondary outcomes
1
Changes in the Bimanual Activity Test scale (BAT)
The scale ranges from 0 to 100, with higher scores indicating better performance
Time frame
From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T02
Changes in the modified Ashworth scale (MAS)
The scale ranges from 0 to 6, with lower scores indicating better performance
Time frame
From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T03
Changes in the Stroke Impact Scale (SIS)
The scale ranges from 0 to 100, with higher scores indicating better performance
Time frame
From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T04
Changes in the Visual Analogue Scale (VAS)
The scale ranges from 0 to 10, with higher scores indicating higher pain
Time frame
From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0Locations
Sponsors and contacts
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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
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