Efficacy of a Rehabilitation Treatment Using Observation THerapy Enhanced by MuscLe Synergy-derived ELectrical StimulatiOn in Post-stroke Patients (OTHELLO)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 (5/week, 3 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age over 18 years;

• Upper arm motor impairment after unilateral stroke as verified by MRI or CT;

• Two weeks up to 6 months after stroke;

• Grading of upper arm motor impairment\>2 at Medical Research Council scale (MRC).

Locations
Other Locations
Italy
IRCCS Fondazione Don Carlo Gnocchi
RECRUITING
Milan
Contact Information
Primary
Monia Cabinio, Ph.D.
mcabinio@dongnocchi.it
+390240308952
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 60
Treatments
Experimental: Action Observation Therapy (AOT) associated with Neuromuscular Electrical Stimulation (NMES)
The group will receive 5 consecutive days a week, for 3 weeks, 60 minutes-long sessions of action observation therapy (AOT) associated with a synchronous neuromuscular stimulation of motor synergies (NMES). After AOT-NMES, subjects will be asked to repeat the observed movement.
Active_comparator: Action Observation Therapy (AOT)
The group will receive 5 consecutive days a week, for 3 weeks, 60 minutes-long sessions of action observation therapy (AOT). The neuromuscular electrical stimulator will be placed on the subjects' arm without synchronous stimulation. After AOT, subjects will be asked to repeat the observed movement.
Placebo_comparator: Observation of motor-neutral stimuli (MNO)
The group will receive 5 consecutive days a week, for 3 weeks, 60 minutes-long sessions of motor-neutral observation (MNO). The neuromuscular electrical stimulator will be placed on the subjects' arm without synchronous stimulation. After MNO, subjects will be asked to execute movements.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Don Carlo Gnocchi Onlus
Collaborators: Istituto di Neuroscienze Consiglio Nazionale delle Ricerche

This content was sourced from clinicaltrials.gov