Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06436898
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-02-16
Brief Title:
Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke
Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Organization:
Fondazione Don Carlo Gnocchi Onlus
Study Overview
Official Title:
Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke PoCH-Rehab
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PoCH-Rehab
Brief Summary:
Persons post-stroke suffer from hemiparesis affecting the functional abilities of the controlesional lower limb Improving walking is therefore a primary rehabilitation goal for such patients Robotic-Assisted Rehabilitation RAR eg exoskeletons and Functional Electrical Stimulation FES are promising techniques to facilitate the functional recovery after stroke allowing benefits to be maintained over long term
Detailed Description:
Exoskeletons were originally developed for subjects with spinal cord injury where they demonstrated a positive impact on rehabilitation and relative costs The investigators expect the same trend also for stroke Based on prior exploratory activities using an overgorund exoskeleton TWIN_Acta in gait rehabilitation post stroke in this project the aim is to merge the potential of an overground exoskeleton and FES to treat the lower limb motor deficits in persons post-stroke strengthening their residual abilities Synchronized pairing of the two devices might boost the functional recovery of gait post-stroke by promoting neural reorganization The persons post stroke will undergo 20 gait rehabiliation sessions with the exoskeleton and with FES applied to the lower limb muscles during execution of gait with the aim of improving various gait and quality of life parameters This experimental intervention will be compared to a control intervention using an exoskeleton alone for gait rehabiltation post stroke
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None