AzTrials
AzTrials

StrokeOTHELLONCT06055569

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

A study testing Rehabilitation protocol: AOT+NMES, Rehabilitation protocol: Action Observation Therapy (AOT) and Observation of motor-neutral stimuli (MNO) in people with Stroke and Stroke Sequelae, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Stroke Sequelae
What is being tested?
Rehabilitation protocol: AOT+NMES, Rehabilitation protocol: Action Observation Therapy (AOT) and Observation of motor-neutral stimuli (MNO)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteItaly
Study dates
1 Nov 2023to 31 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Monia Cabinio, Ph.D. contact

+390240308952

mcabinio@dongnocchi.it

Italy1 site, 1 recruiting
  • IRCCS Fondazione Don Carlo Gnocchi

    Milan, Italia, 20148

    Monia Cabinio, PhD, +390240308952, mcabinio@dongnocchi.it

    Recruiting

Other trials in Italy

About this study

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

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).

Read more

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.

Being tested
Rehabilitation protocol: AOT+NMES, Rehabilitation protocol: Action Observation Therapy (AOT), Observation of motor-neutral stimuli (MNO)
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rehabilitation protocol: AOT+NMESOther

    Action observation and neuromuscular electrical stimulation followed by motor execution

  • Rehabilitation protocol: Action Observation Therapy (AOT)Other

    Action observation followed by motor execution

  • Observation of motor-neutral stimuli (MNO)Other

    Motor-neutral observation followed by motor execution

Study groups in NCT06055569
Study groupRoleWhat they receive
Action Observation Therapy (AOT) associated with Neuromuscular Electrical Stimulation (NMES)ExperimentalThe 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.
Receives: Other: Rehabilitation protocol: AOT+NMES
Action Observation Therapy (AOT)Active comparatorThe 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.
Receives: Other: Rehabilitation protocol: Action Observation Therapy (AOT)
Observation of motor-neutral stimuli (MNO)Placebo comparatorThe 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.
Receives: Other: Observation of motor-neutral stimuli (MNO)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (12)
  1. Changes in measure of upper limb functioning as assessed using the Action Research Arm test (ARAT)

    The ARAT test assess upper limb functioning through the execution of 19 tasks, divided in 4 sub-tests (grasp, grip, pinch, and gross arm movement). Each movement is scored on a 4-point ordinal scale (0=no movement, 1=movement partially performed, 2=movement completed but takes abnormally long; 3=movement performed normally). Total possible score is 57 points, with higher scores associated to best motor functioning.

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

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

    WHODAS 2.0 is an instrument assessing the level of health and disability across all diseases, directly linked to the concepts of the International Classification of Functioning, Disability and Health (ICF). WHODAS 2.0 covers 6 domains (Cognition, Mobility, Self-care, Getting along, Life activities, Participation) and scores range for each item from 0 to 4 (higher scores, higher disability). The 36-items version will be administered. Summary score (possible total score: 144) and domain-specific scores (score 0-24 for each domain) will be considered as outcome measures.

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

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

    The Stroke Impact Scale 3.0 specifically measures quality of life in stroke survivors, considering multiple dimensions (strength, hand function, mobility, activities of daily living (ADL)/instrumental activities of daily living (IADL), memory, communication, emotion, social participation). Each of the 59 items can be rated on a 5-point Likert scale (from 1 to 5), with higher values corresponding to better quality of life. Each subscale of the SIS 3.0 may have a score from 0 to 100.

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

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

    The EQ-5D-5L is an instrument measuring health status, yet applied in different populations and settings. The EQ-5D-5L considers five dimensions (5D: mobility, self-care, usual activities, pain/discomfort and anxiety/depression) each of them measured with a single item scored on 5 levels (5L: no problems, slight problems, moderate problems, severe problems and extreme problems).

    The selected level for each dimension is represented by a single digit (from 1: no problems to 5: extreme problems) and the digits of the five levels are combined in a 5-digits number describing the patient's health state, raging from 11111 (no problems in all dimensions) to 5555 (extreme problems in all dimensions).

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

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

    The MoCA test is a screening tool assessing global cognitive functioning across eight domains (orientation, visuospatial abilities, executive function, naming, memory, attention, language, abstraction). The possible maximun total score is 30, with higher values indicating a more preserved cognitive functioning.

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

  6. Changes in muscular electrical activity during motor acts as measured using surface Electromyography (EMGs).

    Surface Electromyography (EMGs) is a non-invasive tool able to assess muscular electrical activity during the execution of active movements using electrodes applied on the skin surface. Muscular contraction amplitude will be recorded from 24 sensors placed on upper limbs (12 sensors/limb), during the execution of motor acts. Then, the difference between patient's and observed model's temporal dynamic of muscular contraction will be chosen as EMG outcome.

    Measured: Baseline, 1 month (End of treatment)

  7. Changes in the corticospinal excitability, assessed using Motor Evoked Potentials (MEPs).

    Motor evoked potentials (MEPs) can indicate the level of corticospinal excitability and the integrity of motor pathways. Motor potentials in first digital interosseus muscle will be evoked via Transcranial Magnetic Stimulation (TMS, single pulse) and peak-to-peak amplitudes will be recorded as indices of cortico-spinal excitability (i.e. integrity of motor pathways).

    Measured: Baseline, 1 month (End of treatment)

  8. Changes in motoneuron reflex excitability measured as H/M ratio amplitude.

    The H/M ratio is an index of motorneuron reflex excitability. The H/M ratio amplitude will be recorded over the Flexor Carpi Radialis muscle, evoked through the stimulation of the median nerve and eliciting H-reflex in extensor carpi radialis longus (ECRL) and flexor carpi radialis (FCR)

    Measured: Baseline, 1 month (End of treatment)

  9. Changes in movement parameters extracted from body kinematics.

    Kinematics of the upper limb and trunk will be recorded using a 9 camera optoelectronic system during 3D motor acts. The system will measure the 3D coordinates of spherical markers attached to body landmarks to compute trunk, shoulder, elbow and wrist angles.

    Data processing will provide measures of deviations from physiological movement.

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

  10. Changes in muscular synergies

    Muscle synergies will be extracted from the EMG envelope of each subject using the Non Negative Matrix Factorization algorithm.

    Short- and long-term changes induced by treatment in the similarities of muscle synergies with respect to physiological pattern will be evaluated. The module similarity will be measured by the maximum scalar product of the muscle weightings of each module between each participant and the normative reference, while the activation profile similarity by the Pearson's correlation coefficient of the activation profile of each module.

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

  11. Changes in microstructural brain properties, assessed using advanced Magnetic Resonance Imaging (MRI) techniques.

    High-resolution structural sequences will be collected using Magnetic Resonance Imaging at 3.0 Tesla. Data on gray matter will be acquired using MPRAGE (T1w MPRAGE, at least 1x1x1 mm resolution) and FLAIR (1x1x1 mm resolution) sequences. White matter microstructure images will be collected using a DWI protocol (2x2x2 mm resolution, 5 b0 images, 50 directions). Data processing will provide measures of brain integrity, with higher integrity corresponding to more preserved brains.

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

  12. Changes in brain sensory-motor networks, as investigated using functional Magnetic Resonance Imaging (fMRI).

    Sensory-motor brain networks will be assessed using advanced functional Magnetic Resonance Imaging (fMRI) protocols. Data will be acquired on a 3.0T scanner and will provide insights about spared/recovered neural correlates of sensory-motor function.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2023
  2. Study start1 Nov 2023
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06055569
Sponsor's protocol ID
GR-2021-12372038
Acronym
OTHELLO
Status last verified
Nov 2024
First submitted
29 Aug 2023
Last updated
13 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Rehabilitation protocol: AOT+NMES, Rehabilitation protocol: Action Observation Therapy (AOT) and Observation of motor-neutral stimuli (MNO) in people with Stroke and Stroke Sequelae, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Monia Cabinio, Ph.D. (+390240308952, mcabinio@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Baseline, 1 month (End of treatment), 6 months (Follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in