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

NCT06055569 | Recruiting

• 1 other identifier: GR-2021-12372038
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  The Fugl-Meyer Assessment of Motor Recovery after Stroke is one of the most widely used measures of motor impairment in post-stroke hemiplegic patients, covering 5 domains (Motor function, sensory function, balance, joint range of motion, joint pain). The assessment of upper extremity motion is performed using the Upper Extremity assessment (FMA-UE), including items scored on a 3-point ordinal scale (0: cannot perform, 1: performs partially; 2: performs fully) with total maximum score: 66 points (higher scores, best clinical profile).

  Baseline, 1 month (End of treatment), 6 months (Follow-up)

Secondary Outcomes (12)

• Changes in measure of upper limb functioning as assessed using the Action Research Arm test (ARAT)

  Baseline, 1 month (End of treatment), 6 months (Follow-up)

• Changes in health and disability status as measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

  Baseline, 1 month (End of treatment), 6 months (Follow-up)

• Changes in Stroke-associated quality of life as assessed using specific subscores of the Stroke Impact Scale (SIS) 3.0

  Baseline, 1 month (End of treatment), 6 months (Follow-up)

• Changes in quality of life as self-rated in the EuroQol five dimensions (5D) and five levels (5L) questionnaire (EQ-5D-5L)

  Baseline, 1 month (End of treatment), 6 months (Follow-up)

• Changes in global cognitive functioning as assessed using the Montreal COgnitive Assessment (MoCA) score.

  Baseline, 1 month (End of treatment), 6 months (Follow-up)

Other Outcomes (2)

• Technological usability of the rehabilitation system, measured using the System Usability Scale (SUS)

  1 month (End of treatment)

• Treatment safety measured as total number of adverse events

  1 month (End of treatment)

Study Arms (3)

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

EXPERIMENTAL

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.

Other: Rehabilitation protocol: AOT+NMES

Action Observation Therapy (AOT)

ACTIVE COMPARATOR

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.

Other: Rehabilitation protocol: Action Observation Therapy (AOT)

Observation of motor-neutral stimuli (MNO)

PLACEBO COMPARATOR

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.

Other: Observation of motor-neutral stimuli (MNO)

Interventions

Rehabilitation protocol: AOT+NMES OTHER

Action observation and neuromuscular electrical stimulation followed by motor execution

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

Rehabilitation protocol: Action Observation Therapy (AOT) OTHER

Action observation followed by motor execution

Action Observation Therapy (AOT)

Observation of motor-neutral stimuli (MNO) OTHER

Motor-neutral observation followed by motor execution

Observation of motor-neutral stimuli (MNO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Istituto di Neuroscienze Consiglio Nazionale delle Ricerche: collaborator

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi

Milan, Italia, 20148, Italy

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Monia Cabinio, Ph.D.

CONTACT

+390240308952; mcabinio@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 26, 2023
• Study Start: November 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: March 31, 2026
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)