Clinical trial NCT06055569: Efficacy of Rehabilitation Using Action Observation and Muscle Stimulation in Post-stroke Patients.
Official title: Efficacy of a Rehabilitation Treatment Using Observation THerapy Enhanced by MuscLe Synergy-derived ELectrical StimulatiOn in Post-stroke Patients (OTHELLO)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Stroke Sequelae
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
First posted: 2023-09-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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 criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* Neurological/orthopedic issues that would interfere with upper limb exercises;
* Presence of any medical condition that represents a contraindication to Magnetic Resonance Imaging (MRI) examination or to Transcranial Magnetic Stimulation (TMS);
* Presence of dermatologic issues that will interfere with neuromuscular stimulator;
* Presence of electronic subcutaneous implants;
* Presence of peripheral neuropathy;
* Epilepsy;
* Pregnancy;
* Presence of severe cognitive impairment, including language comprehension detected during the neurological evaluation.

Primary outcomes:
measure: Changes in measure of upper extremity motor performance as assessed using the Fugl-Meyer Assessment of Motor Recovery after Stroke - Upper Extremity (FMA-UE) score.
timeFrame: Baseline, 1 month (End of treatment), 6 months (Follow-up)
Secondary outcomes:
measure: Changes in measure of upper limb functioning as assessed using the Action Research Arm test (ARAT)
timeFrame: Baseline, 1 month (End of treatment), 6 months (Follow-up)
measure: Changes in health and disability status as measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Baseline, 1 month (End of treatment), 6 months (Follow-up)
measure: Changes in Stroke-associated quality of life as assessed using specific subscores of the Stroke Impact Scale (SIS) 3.0
timeFrame: Baseline, 1 month (End of treatment), 6 months (Follow-up)
measure: Changes in quality of life as self-rated in the EuroQol five dimensions (5D) and five levels (5L) questionnaire (EQ-5D-5L)
timeFrame: Baseline, 1 month (End of treatment), 6 months (Follow-up)
measure: Changes in global cognitive functioning as assessed using the Montreal COgnitive Assessment (MoCA) score.
timeFrame: Baseline, 1 month (End of treatment), 6 months (Follow-up)
measure: Changes in muscular electrical activity during motor acts as measured using surface Electromyography (EMGs).
timeFrame: Baseline, 1 month (End of treatment)
measure: Changes in the corticospinal excitability, assessed using Motor Evoked Potentials (MEPs).
timeFrame: Baseline, 1 month (End of treatment)
measure: Changes in motoneuron reflex excitability measured as H/M ratio amplitude.
timeFrame: Baseline, 1 month (End of treatment)
measure: Changes in movement parameters extracted from body kinematics.
timeFrame: Baseline, 1 month (End of treatment), 6 months (Follow-up)
measure: Changes in muscular synergies
timeFrame: Baseline, 1 month (End of treatment), 6 months (Follow-up)
measure: Changes in microstructural brain properties, assessed using advanced Magnetic Resonance Imaging (MRI) techniques.
timeFrame: Baseline, 1 month (End of treatment), 6 months (Follow-up)
measure: Changes in brain sensory-motor networks, as investigated using functional Magnetic Resonance Imaging (fMRI).
timeFrame: Baseline, 1 month (End of treatment), 6 months (Follow-up)
Other outcomes:
measure: Technological usability of the rehabilitation system, measured using the System Usability Scale (SUS)
timeFrame: 1 month (End of treatment)
measure: Treatment safety measured as total number of adverse events
timeFrame: 1 month (End of treatment)
Locations:
city: Milano
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
state: Italia
Study officials:
References: