Neuroimaging Biomarkers Toward a Personalized Upper Limb Action Observation Treatment in Chronic Stroke Patients

NCT04047134 | Unknown DMC

• 2 other identifiers: 05/2018GR-2016 - 02361678
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Much recent interest was raised by the use of Action Observation Treatment (AOT) in stroke patients rehabilitation. AOT, well-grounded in neurophysiology, is an updated approach, based on mirror neuron system (MNS) used to rebuild motor function despite injuries by engaging the brain regions active during action execution in individuals with limited mobility. This project aims at identifying, for the first time in Italy, neurophysiological electroencephalographic (EEG) biomarkers able to predict rehabilitation outcomes and providing an innovative optimized AOT rehabilitation protocol for chronic Stroke outpatients. EEG will be recorded to identify the most effective stimuli, quantify changes/recovery, profile patients. Moreover, an innovative AOT home-based program will be implemented. The translational research results will ensure advances in the optimization and personalization of the rehabilitative process thus contributing to improve the quality of life of chronic stroke patients. Stroke is a leading cause of death and one of the greatest causes of long-term disability that interferes with a good quality of life. Nowadays the rehabilitation interventions are the major component of patient's care to achieve functional outcome. In the last few years, in order to improve Activity of Daily Living (ADL), new noninvasive strategies have emerged as rehabilitative treatments rather than traditional physical therapies. The Action Observation Treatment (AOT), supported by results collected through randomized controlled trials, is one of these. This new rehabilitation approach is based on the properties of the Mirror Neuron System (MNS; 11-13). The extensive research of the last 20 years on the human MNS (hMNS) showed its importance not only in action recognition but also in motor intentions and other social cognitive functions. Lastly, because recruited also in damage brain (18,19), the MNS is demonstrated to provide satisfactory rehabilitative outcomes. The AOT takes advantage of the opportunity to restore functions despite the patient's impairment and it seems to be a valid example of translational medicine from basic neuroscience to rehabilitation. To date, neurophysiological outcomes were never used for translational purposes aimed to the optimization of the therapy and no evidence, in Italy, related to the effectiveness of the home-based program were proposed.

Conditions

Chronic Stroke

Keywords

Prevention and treatment of movement; Motor Function; Action Observation Therapy; Mirror Neuron System; Upper Limb Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer (FM) Test

  The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The scale is comprised of five domains and there are 155 items in total: * Motor functioning (the score ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity. * Sensory functioning (from 0 to 24 points) * Balance (from 0 to 14) * Joint range of motion (from 0 to 44) * Joint pain (from 0 to 44 ) Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.

  At baseline-day 0 (T0), the middle of the treatment-day 15 (T1), at the end treatment-day 30 (T2), and at the follow up visit-day 90 (2 months both for the hospital-based and for the home based program) (T3)

Secondary Outcomes (1)

• Change in Frenchay Arm Test (FAT)

  At baseline-day 0 (T0), the middle of the treatment-day 15 (T1), at the end treatment-day 30 (T2), and at the follow up visit-day 90 (2 months both for the hospital-based and for the home based program) (T3)

Other Outcomes (7)

• Change in Box and Block Test (BBT)

  At baseline-day 0 (T0), the middle of the treatment-day 15 (T1), at the end treatment-day 30 (T2), and at the follow up visit-day 90 (2 months both for the hospital-based and for the home based program) (T3)

• Change in Modified Ashworth Scale (MSA)

  At baseline-day 0 (T0), the middle of the treatment-day 15 (T1), at the end treatment-day 30 (T2), and at the follow up visit-day 90 (2 months both for the hospital-based and for the home based program) (T3)

• Change in Modified Bartel Index (mBI)

  At baseline-day 0 (T0), the middle of the treatment-day 15 (T1), at the end treatment-day 30 (T2), and at the follow up visit-day 90 (2 months both for the hospital-based and for the home based program) (T3)

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

The Experimental Group (EG) will observe and execute/repeat Activities of Daily Living (ADL) actions.

Other: Action Observation Treatrment

Control Group (CG)

ACTIVE COMPARATOR

The COntrol Group (CG) will observe landscapes and perform the same actions observed by their peers but after verbal instructions.

Other: Observation of videos with Non Motor contents

Interventions

Action Observation Treatrment OTHER

Participants will be asked to carefully observe the videos showing different daily actions. Each action will consist of 3 to 4 constituent motor acts. Each motor act will be presented for 3 minutes, totally lasting 12 min/video. At the end of each motor act presentation, participants will be asked to execute with the affected hand the observed motor sequence for 2 minutes (20 minutes/session). 10 daily actions will be recorded. Each video will be presented to participants twice a day, in order to complexity as judged by the experimenter. Only 1 typology of motor task per day for each condition, starting from the easiest and ending with the most complex action throughout 15 sessions spread on 5 weeks (3 sessions/week). Tasks will be based on some relevant activities of daily living belonging to at least one between feeding, self-care or external actions category on the affected side. Each session will last about 15 minutes and will be repeated twice a day, at least 60 minutes apart.

Also known as: AOT

Experimental Group (EG)

Observation of videos with Non Motor contents OTHER

Participants will be asked to observe video clips with no specific motor content. Videos will concern scientific, geographical and historical issues. As for cases, video clips will be divided into three to four parts. At the end of each part, controls will execute the same actions as cases, in the same order. In this way cases and controls will undergo the same amount of motor practice and receive the same amount of visual stimulation, the only difference being the content of visual stimuli.

Also known as: NMO

Control Group (CG)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic stroke (never experienced AOT);
• first-ever unilateral stroke due to ischemia provoking a clinically evident upper limb/hand deficit;
• diagnosis verified by brain imaging (MRI);
• cognitive function sufficient to understand the experimental instructions
• Chedoke-McMaster stroke Assessment Scale score greater than 1;
• informed written consent to participate in the study.

You may not qualify if:

• bilateral impairment,
• severe sensory deficits in the paretic upper limb,
• cognitive impairment or behavioral dysfunction,
• refusal or inability to provide informed consent and
• other current severe medical problems.

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Casa di Cura del Policlinico di Milano: collaborator

Study Sites (2)

Casa di Cura del Policlinico di Milano

Milan, MI, Italy

NOT YET RECRUITING

IRCCS San Raffaele Pisana

Rome, RM, 00166, Italy

RECRUITING

Related Publications (31)

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• Tropea P, Infarinato F, Sterpi I, Ottaviani M, Antoniotti P, Romano P, Picardi M, Goffredo M, Re R, Pournajaf S, Seregni A, Caronni A, Franceschini M, Corbo M. Action Observation Treatment for Upper Limb Rehabilitation in Patients With Stroke: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2023 Apr 20;12:e42094. doi: 10.2196/42094.

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Study Officials

• Francesco Infarinato, Phd

  IRCSS San Raffaele Pisana

  STUDY CHAIR

Central Study Contacts

Francesco Infarinato, Phd

CONTACT

+39065225; francesco.infarinato@sanraffaele.it

Sanaz Pournajaf, PT

CONTACT

+39065225; sanaz.pournajaf@sanraffaele.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible of Rehab-bioengeneering lab.

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 6, 2019
• Study Start: July 1, 2019
• Primary Completion: November 30, 2022
• Study Completion: January 30, 2023
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)