Bimanual Robotic Exoskeletal Platform for the Treatment of the Upper Limb in Patients With Stroke. A Feasibility Study
NCT05176600 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2022-04-29
Summary
The purpose of the study is to test the technical functionality, safety, and feasibility of a bimanual robotic exoskeletal platform and associated serious games in order to offer information on technological and functional advances that will be included in the device's finalization.
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).
Conditions
Interventions
- DEVICE
-
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.
- DEVICE
-
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.
Sponsors & Collaborators
-
Fondazione Don Carlo Gnocchi Onlus
collaborator OTHER -
Wearable Robotics srl.
lead INDUSTRY
Principal Investigators
-
Irene Aprile, MD, PhD · Fondazione Don Carlo Gnocchi Onlus
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-10
- Primary Completion
- 2022-09-30
- Completion
- 2022-09-30
Countries
- Italy
Study Locations
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