Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06055569
Status:
RECRUITING
Last Update Posted:
2023-12-28
First Post:
2023-08-29
Brief Title:
Efficacy of Rehabilitation Using Action Observation and Muscle Stimulation in Post-stroke Patients
Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Organization:
Fondazione Don Carlo Gnocchi Onlus
Study Overview
Official Title:
Efficacy of a Rehabilitation Treatment Using Observation THerapy Enhanced by muscLe Synergy-derived eLectrical stimulatiOn in Post-stroke Patients OTHELLO
Status:
RECRUITING
Status Verified Date:
2023-12
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:
OTHELLO
Brief Summary:
Stroke is the third most common cause of disability worldwide and leads to upper limb motor disease in more than half of people affected
Recent data demonstrate that upper limb rehabilitation can be pursued using techniques such as the observation of action Action Observation Therapy - AOT or the stimulation of limb musculature using surface electrodes Neuromuscular Electrical Stimulation - NMES
To date no rehabilitation studies used both the treatments AOT-NMES for the rehabilitation of upper limb after stroke
The goal of this clinical trial is to study the efficacy of this combined approach AOT-NMES in people who developed upper limb motor impairment after stroke
The main question this study aims to answer is if the rehabilitation performed using both action observation and neuromuscular stimulation has an higher efficacy than the use of AOT alone and higher than the observation of non-motor stimuli
Participants will be people with upper limb impairment after stroke and will perform 15 rehabilitation sessions 5week 6 weeks 60 minutes each
Each participant will be casually included in one of following three rehabilitation groups
Action observation associated with neuromuscular stimulation AOT-NMES experimental condition they will observe upper limb movements while their arm muscles will be stimulated After the observation phase they will try to perform the same movements with the impaired arm
Action observation alone AOT subjects will observe upper limb movements and after the observation phase then they will try to execute them with the impaired arm
Motor-neutral observation MNO subjects will observe non-movement videos and after the observation phase they will try to execute upper limb movements with the impaired arm
Each participant will be evaluated for motor function before and after rehabilitation treatment and researchers will compare the motion improvement between the groups to assess the efficacy of AOT-NMES over other treatments
Recent data demonstrate that upper limb rehabilitation can be pursued using techniques such as the observation of action Action Observation Therapy - AOT or the stimulation of limb musculature using surface electrodes Neuromuscular Electrical Stimulation - NMES
To date no rehabilitation studies used both the treatments AOT-NMES for the rehabilitation of upper limb after stroke
The goal of this clinical trial is to study the efficacy of this combined approach AOT-NMES in people who developed upper limb motor impairment after stroke
The main question this study aims to answer is if the rehabilitation performed using both action observation and neuromuscular stimulation has an higher efficacy than the use of AOT alone and higher than the observation of non-motor stimuli
Participants will be people with upper limb impairment after stroke and will perform 15 rehabilitation sessions 5week 6 weeks 60 minutes each
Each participant will be casually included in one of following three rehabilitation groups
Action observation associated with neuromuscular stimulation AOT-NMES experimental condition they will observe upper limb movements while their arm muscles will be stimulated After the observation phase they will try to perform the same movements with the impaired arm
Action observation alone AOT subjects will observe upper limb movements and after the observation phase then they will try to execute them with the impaired arm
Motor-neutral observation MNO subjects will observe non-movement videos and after the observation phase they will try to execute upper limb movements with the impaired arm
Each participant will be evaluated for motor function before and after rehabilitation treatment and researchers will compare the motion improvement between the groups to assess the efficacy of AOT-NMES over other treatments
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