Efficacy of Rehabilitation Using Action Observation and Muscle Stimulation in Post-stroke Patients. (OTHELLO)

Don Carlo Gnocchi Onlus Foundation

Status: Enrolling

Conditions: Stroke; Stroke Sequelae

Treatments: Other: Rehabilitation protocol: Action Observation Therapy (AOT); Other: Observation of motor-neutral stimuli (MNO); Other: Rehabilitation protocol: AOT+NMES

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06055569

GR-2021-12372038

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Action Observation Therapy (AOT) associated with Neuromuscular Electrical Stimulation (NMES)

Experimental group

Description:

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.

Treatment:

Other: Rehabilitation protocol: AOT+NMES

Action Observation Therapy (AOT)

Active Comparator group

Description:

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.

Treatment:

Other: Rehabilitation protocol: Action Observation Therapy (AOT)

Observation of motor-neutral stimuli (MNO)

Placebo Comparator group

Description:

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.

Treatment:

Other: Observation of motor-neutral stimuli (MNO)