Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05713890
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-01-26
Brief Title:
Home-based Action Observation Treatment With Virtual-reality for Arm Rehabilitation in People With Multiple Sclerosis
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
An Integrated and Home-based Motor Rehabilitation Combining Virtual Reality and Action Observation Treatment in People With Multiple Sclerosis a Clinical and Neuroimaging Study
Status:
RECRUITING
Status Verified Date:
2023-09
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:
None
Brief Summary:
Action Observation Treatment AOT is a rehabilitative strategy which has been proposed as a promising approach to improve motor performance in neurological conditions including multiple sclerosis MS
In this clinical trial the investigators aim to explore the role of a home-based AOT with virtual reality VR in improving upper limb motor function in people with MS PwMS The objectives are
To compare the effects of home-based VR-AOT versus VR-landscape observation LO on upper limb motor performance
To measure brain network functional changes functional plasticity and structural variations of gray matter GM and white matter WM structural plasticity using advanced magnetic resonance imaging MRI techniques following VR-AOT and VR-LO
To study the correlations between MRI changes and clinical improvements and the predictors of VR-AOT efficacy
All participants will undergo treatment sessions for 3 weeks 5 consecutive daysweek total15 sessions lasting 30 minutes each Those in the VR-AOT group will observe imagine and execute two upper limb motor tasks in each session Those in the VR-LO group will perform the same tasks but they will observe inanimate landscapes beforehand instead
In this clinical trial the investigators aim to explore the role of a home-based AOT with virtual reality VR in improving upper limb motor function in people with MS PwMS The objectives are
To compare the effects of home-based VR-AOT versus VR-landscape observation LO on upper limb motor performance
To measure brain network functional changes functional plasticity and structural variations of gray matter GM and white matter WM structural plasticity using advanced magnetic resonance imaging MRI techniques following VR-AOT and VR-LO
To study the correlations between MRI changes and clinical improvements and the predictors of VR-AOT efficacy
All participants will undergo treatment sessions for 3 weeks 5 consecutive daysweek total15 sessions lasting 30 minutes each Those in the VR-AOT group will observe imagine and execute two upper limb motor tasks in each session Those in the VR-LO group will perform the same tasks but they will observe inanimate landscapes beforehand instead
Detailed Description:
None
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