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

NCT ID: NCT06055569

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-03-31

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.

Conditions

Stroke; Stroke Sequelae

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Rehabilitation protocol: AOT+NMES

Intervention Type: OTHER

Action observation and neuromuscular electrical stimulation followed by motor execution

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.

Group Type: ACTIVE_COMPARATOR

Rehabilitation protocol: Action Observation Therapy (AOT)

Intervention Type: OTHER

Action observation followed by motor execution

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.

Group Type: PLACEBO_COMPARATOR

Observation of motor-neutral stimuli (MNO)

Intervention Type: OTHER

Motor-neutral observation followed by motor execution

Interventions

Rehabilitation protocol: AOT+NMES

Action observation and neuromuscular electrical stimulation followed by motor execution

Intervention Type: OTHER

Rehabilitation protocol: Action Observation Therapy (AOT)

Action observation followed by motor execution

Intervention Type: OTHER

Observation of motor-neutral stimuli (MNO)

Motor-neutral observation followed by motor execution

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto di Neuroscienze Consiglio Nazionale delle Ricerche

NETWORK

Sponsor Role: collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Fondazione Don Carlo Gnocchi

Milan, Italia, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Monia Cabinio, Ph.D.

Role: CONTACT

mcabinio@dongnocchi.it

+390240308952

Facility Contacts

Monia Cabinio, PhD

Role: primary

mcabinio@dongnocchi.it

+390240308952

Other Identifiers

GR-2021-12372038

Identifier Type: -

Identifier Source: org_study_id