Ignite Creation Date:
2024-05-06 @ 8:36 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02770300
Status:
TERMINATED
Last Update Posted:
2022-10-17
First Post:
2016-03-30
Brief Title:
Effect of Personalized Robotic Therapy
Sponsor:
Wearable Robotics srl
Organization:
Wearable Robotics srl
Study Overview
Official Title:
Effect of an Automatic Personalized Robot-assisted Rehabilitation on Cortical Organization and Clinical Recovery After Stroke
Status:
TERMINATED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was prematurely terminated by the sponsor in both centers because the recruitment in the two centers was slow and it stopped during COVID period
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary goal of this project is to test the safeness and clinical effectiveness of a novel exoskeleton for the upper limb Arm Light Exoskeleton Rehab Station ALEx RS developed at Wearable Robotics srl for the force assistance of stroke patients during robotic-rehabilitation
The secondary study aim is to design and test an automatic personalized robot-based upper limb motor rehabilitation protocol targeting the specific kinematic performance of each patient
Finally the study also aims to define the neuro-biomechanical state of the patient and its evolution during the therapy by studying cortical signals and muscular synergies This information will be used to improve the personalization of the robotic treatment by targeting not only the motor performance but also the cerebral and muscular activity of the patient
The study is longitudinally designed in order to test the safeness and clinical effectiveness of ALEx RS over time and to monitor the clinical effectiveness of the automatic personalized robotic therapy from the beginning until the end of the treatment Moreover in order to estimate the long-term clinical effectiveness of the treatment the assessment methods proposed in the clinical trial will be repeated one month after the end of the treatment
The secondary study aim is to design and test an automatic personalized robot-based upper limb motor rehabilitation protocol targeting the specific kinematic performance of each patient
Finally the study also aims to define the neuro-biomechanical state of the patient and its evolution during the therapy by studying cortical signals and muscular synergies This information will be used to improve the personalization of the robotic treatment by targeting not only the motor performance but also the cerebral and muscular activity of the patient
The study is longitudinally designed in order to test the safeness and clinical effectiveness of ALEx RS over time and to monitor the clinical effectiveness of the automatic personalized robotic therapy from the beginning until the end of the treatment Moreover in order to estimate the long-term clinical effectiveness of the treatment the assessment methods proposed in the clinical trial will be repeated one month after the end of the treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None