Bimanual Robotic Exoskeletal Platform for the Treatment of the Upper Limb in Patients With Stroke. A Feasibility Study
NCT ID: NCT05176600
Last Updated: 2022-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-01-10
2022-09-30
Brief Summary
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In addition, a secondary goal will be to assess the therapeutic effects of a rehabilitation therapy based on the bimanual configuration, comparing it to a unimanual treatment delivered on the same platform (using the specific configuration).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bimanual group
In this group, patients will perform a robotic rehabilitation based on bimanual serious games
Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and bimanual serious games
Patients will undergo a bimanual 30-session robotic rehabilitation, using the robot ALEx RS with the bimanual configuration and the related serious games. Each session will last 45 minute. Daily sessions will be provided, five days a week.
Unimanual group
In this group, patients will perform a robotic rehabilitation based on unimanual serious games
Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and unimanual serious games
Patients will undergo a unimanual 30-session robotic rehabilitation, using the robot ALEx RS with the unimanual configuration and the related serious games.Daily sessions will be provided, five days a week.
Interventions
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Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and bimanual serious games
Patients will undergo a bimanual 30-session robotic rehabilitation, using the robot ALEx RS with the bimanual configuration and the related serious games. Each session will last 45 minute. Daily sessions will be provided, five days a week.
Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and unimanual serious games
Patients will undergo a unimanual 30-session robotic rehabilitation, using the robot ALEx RS with the unimanual configuration and the related serious games.Daily sessions will be provided, five days a week.
Eligibility Criteria
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Inclusion Criteria
* weight not exceeding 130 kg;
* ischemic injury;
* first cortical and supra-tentorial event;
* moderate motor deficit of the upper limb (score on the Fugl-Meyer Assessment - Upper Extremity between 29 and 42);
* time since stroke event between 1 and 6 months;
* trunk control test score greater than or equal to 48;
* healthy bone density and skeleton that does not suffer from unhealed fractures.
Exclusion Criteria
* Cognitive impairment that prevents understanding of the exercises administered;
* Unavailability to provide informed consent;
* Pregnant women;
* Severe spasticity (Ashworth 4);
* Major muscle contractures;
* Excessive asymmetry in the length of the arms;
* Upper limb prostheses;
* Excessive joint limitations that make it difficult or painful to use the device;
* Use of pacemakers or implantation of active devices;
* Patients who already participate in another clinical study or who are already undergoing another similar robotic rehabilitation treatment.
18 Years
85 Years
ALL
No
Sponsors
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Fondazione Don Carlo Gnocchi Onlus
OTHER
Wearable Robotics srl.
INDUSTRY
Responsible Party
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Lucia Lencioni
CEO
Principal Investigators
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Irene Aprile, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Don Carlo Gnocchi Onlus
Locations
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Fondazione Don Carlo Gnocchi
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FDG_Birehab_2021
Identifier Type: -
Identifier Source: org_study_id
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