Chronic StrokeBE-TOPNCT04047134
Neuroimaging Biomarkers Toward a Personalized Upper Limb Action Observation Treatment in Chronic Stroke Patients
A study testing Action Observation Treatrment and Observation of videos with Non Motor contents in people with Chronic Stroke, run by IRCCS San Raffaele at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Action Observation Treatrment and Observation of videos with Non Motor contents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jul 2019to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Not yet recruiting
Casa di Cura del Policlinico di Milano
Milan, MI
Irma Sterpi, PhD, i.sterpi@ccppdezza.it
Irma Sterpi, PhD
- Recruiting
IRCCS San Raffaele Pisana
Rome, RM, 00166
Astrid Van Rijn, +39-065225 ext. 3405, astrid.vanrijn@sanraffaele.it
Sanaz Pournajaf, PT, +39-065225 ext. 2319, sanaz.pournajaf@sanraffaele.it
About this study
Official title: Neuroimaging Biomarkers Toward an Optimized and Personalized Action Observation Treatment in Chronic Stroke Patients: New Strategies to Maximize the Efficacy of Upper Limb Functional Rehabilitation.
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.
Read the detailed description
This study protocol provides 3 experimental designs to satisfy 3 different specific aims as follows.
Experimental design aim 1:
To assess which kind of ADL visual stimuli will be most effective inducing motor excitability during action observation, EEG recording will be performed. 20 Stroke patients (10 with right lesion and 10 left one) will be recruited and video of feeding, self care and external actions showed. The EEG biomarkers will be identify. A comparison on EEG rhythm and biomarkers between the two groups and the ADL categories observed will be investigated. The most effective category will be subsequently selected for the Randomized Controlled Trial (RCT).
Experimental design aim 2:
This is an RCT study aimed to deeply investigate if EEG biomarkers are predictive of effectiveness of AOT on 40 Chronic Stroke outpatients in order to confirm the translational power of the optimized treatment. The subjects accurately enrolled for hospital program, will be randomly assigned to the Experimental Group (EG) or to the Control one (CG). The EG will observe and execute ADL actions, the CG will observe landscapes and perform the same actions observed by the others one but after verbal instructions. For each condition the patient will be presented with only 1 typology of motor task per day, 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. Before, after and in the middle of the treatment sessions all patients will be clinically, neurophysiologically (EEG and EMG) and behaviorally (Kinematics) assessed to verify neural plasticity and motor recovery.
The follow-up at 2 months later will be carried out to assess retention of effects.
Experimental design aim 3:
The health policy to develop appropriate home-based rehabilitation programs for chronic stroke patients (24,25) could induce to explore whether AOT can meet the necessary translational requirements also for this type of care. A New group of 20 chronic stroke patients will be recruited and randomly assigned to the EG OR CG to follow the optimized AOT rehabilitation programs.
After appropriate training of patients and caregivers, the use of tablets will let the home-based treatment. The investigators will define a low-cost highly accessible system based on tablet consumer technology for facilitating the AOT. In particular a tablet will be proposed with a web-based program that will be used to train the patients and receive a feedback of their progress.
The whole treatment period will last 6 weeks. The focus of this evaluation will be on the feasibility of the home-based treatment and the usability of the platform as well as the subjects satisfaction with the services. A preliminary estimate of the recovery and overall improvement of functional performances of participants will also be provided with respect to clinical outcomes.
- Conditions
- Chronic Stroke
- Being tested
- Action Observation Treatrment, Observation of videos with Non Motor contents
- Keywords
- Prevention and treatment of movement, Motor Function, Action Observation Therapy, Mirror Neuron System, Upper Limb Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation TreatrmentOther
Also called AOT
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.
Observation of videos with Non Motor contentsOther
Also called NMO
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (EG) | Experimental | The Experimental Group (EG) will observe and execute/repeat Activities of Daily Living (ADL) actions. Receives: 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. Receives: Other: Observation of videos with Non Motor contents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The Frenchay Arm Test (FAT) is a measure of upper extremity proximal motor control and dexterity during ADL performance in patients with impairments resulting from neurological conditions. The FAT is an upper extremity specific measure of activity limitation.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Jul 2019
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Casa di Cura del Policlinico di Milano
- Responsible party
- Principal investigator, Francesco Infarinato, IRCCS San Raffaele
- Investigators
- Francesco Infarinato, Phd, Study chair, IRCSS San Raffaele Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047134
- Sponsor's protocol ID
- 05/2018
- Other IDs
- GR-2016 - 02361678
- Acronym
- BE-TOP
- Status last verified
- Aug 2022
- First submitted
- 31 Jul 2019
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gosman-Hedstrom G, Claesson L, Blomstrand C. Consequences of severity at stroke onset for health-related quality of life (HRQL) and informal care: a 1-year follow-up in elderly stroke survivors. Arch Gerontol Geriatr. 2008 Jul-Aug;47(1):79-91. doi: 10.1016/j.archger.2007.07.006. Epub 2007 Sep 14.
PubMed 17868935Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD008349. doi: 10.1002/14651858.CD008349.pub2.
PubMed 21901720Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, van Wijck F. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2.
PubMed 25387001Michielsen ME, Selles RW, van der Geest JN, Eckhardt M, Yavuzer G, Stam HJ, Smits M, Ribbers GM, Bussmann JB. Motor recovery and cortical reorganization after mirror therapy in chronic stroke patients: a phase II randomized controlled trial. Neurorehabil Neural Repair. 2011 Mar-Apr;25(3):223-33. doi: 10.1177/1545968310385127. Epub 2010 Nov 4.
PubMed 21051765Ertelt D, Small S, Solodkin A, Dettmers C, McNamara A, Binkofski F, Buccino G. Action observation has a positive impact on rehabilitation of motor deficits after stroke. Neuroimage. 2007;36 Suppl 2:T164-73. doi: 10.1016/j.neuroimage.2007.03.043. Epub 2007 Mar 31.
PubMed 17499164Franceschini M, Agosti M, Cantagallo A, Sale P, Mancuso M, Buccino G. Mirror neurons: action observation treatment as a tool in stroke rehabilitation. Eur J Phys Rehabil Med. 2010 Dec;46(4):517-23. Epub 2010 Apr 23.
PubMed 20414184Franceschini M, Ceravolo MG, Agosti M, Cavallini P, Bonassi S, Dall'Armi V, Massucci M, Schifini F, Sale P. Clinical relevance of action observation in upper-limb stroke rehabilitation: a possible role in recovery of functional dexterity. A randomized clinical trial. Neurorehabil Neural Repair. 2012 Jun;26(5):456-62. doi: 10.1177/1545968311427406. Epub 2012 Jan 10.
PubMed 22235059Buccino G, Arisi D, Gough P, Aprile D, Ferri C, Serotti L, Tiberti A, Fazzi E. Improving upper limb motor functions through action observation treatment: a pilot study in children with cerebral palsy. Dev Med Child Neurol. 2012 Sep;54(9):822-8. doi: 10.1111/j.1469-8749.2012.04334.x. Epub 2012 Jul 6.
PubMed 22765352Brunner IC, Skouen JS, Ersland L, Gruner R. Plasticity and response to action observation: a longitudinal FMRI study of potential mirror neurons in patients with subacute stroke. Neurorehabil Neural Repair. 2014 Nov-Dec;28(9):874-84. doi: 10.1177/1545968314527350. Epub 2014 Mar 18.
PubMed 24642381Gallese V, Fadiga L, Fogassi L, Rizzolatti G. Action recognition in the premotor cortex. Brain. 1996 Apr;119 ( Pt 2):593-609. doi: 10.1093/brain/119.2.593.
PubMed 8800951Fogassi L, Ferrari PF, Gesierich B, Rozzi S, Chersi F, Rizzolatti G. Parietal lobe: from action organization to intention understanding. Science. 2005 Apr 29;308(5722):662-7. doi: 10.1126/science.1106138.
PubMed 15860620Bonini L, Rozzi S, Serventi FU, Simone L, Ferrari PF, Fogassi L. Ventral premotor and inferior parietal cortices make distinct contribution to action organization and intention understanding. Cereb Cortex. 2010 Jun;20(6):1372-85. doi: 10.1093/cercor/bhp200. Epub 2009 Oct 5.
PubMed 19805419Campione GC, Gentilucci M. Is the observation of the human kinematics sufficient to activate automatic imitation of transitive actions? Behav Brain Res. 2011 Nov 20;225(1):201-8. doi: 10.1016/j.bbr.2011.07.025. Epub 2011 Jul 23.
PubMed 21802449Rizzolatti G, Sinigaglia C. The functional role of the parieto-frontal mirror circuit: interpretations and misinterpretations. Nat Rev Neurosci. 2010 Apr;11(4):264-74. doi: 10.1038/nrn2805. Epub 2010 Mar 10.
PubMed 20216547Rizzolatti G, Cattaneo L, Fabbri-Destro M, Rozzi S. Cortical mechanisms underlying the organization of goal-directed actions and mirror neuron-based action understanding. Physiol Rev. 2014 Apr;94(2):655-706. doi: 10.1152/physrev.00009.2013.
PubMed 24692357
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Biomarkers Toward an Optimized and Personalized Action Observation Treatment in Chronic Stroke Patients: New Strategies to Maximize the Efficacy of Upper Limb Functional Rehabilitation.
- ClinicalTrials.gov ID
- NCT04047134
- Acronym / sponsor ID
- BE-TOP / 05/2018
- Conditions
- Chronic Stroke
- Keywords
- Prevention and treatment of movement, Motor Function, Action Observation Therapy, Mirror Neuron System, Upper Limb Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Casa di Cura del Policlinico di Milano
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study protocol provides 3 experimental designs to satisfy 3 different specific aims as follows.
Experimental design aim 1:
To assess which kind of ADL visual stimuli will be most effective inducing motor excitability during action observation, EEG recording will be performed. 20 Stroke patients (10 with right lesion and 10 left one) will be recruited and video of feeding, self care and external actions showed. The EEG biomarkers will be identify. A comparison on EEG rhythm and biomarkers between the two groups and the ADL categories observed will be investigated. The most effective category will be subsequently selected for the Randomized Controlled Trial (RCT).
Experimental design aim 2:
This is an RCT study aimed to deeply investigate if EEG biomarkers are predictive of effectiveness of AOT on 40 Chronic Stroke outpatients in order to confirm the translational power of the optimized treatment. The subjects accurately enrolled for hospital program, will be randomly assigned to the Experimental Group (EG) or to the Control one (CG). The EG will observe and execute ADL actions, the CG will observe landscapes and perform the same actions observed by the others one but after verbal instructions. For each condition the patient will be presented with only 1 typology of motor task per day, 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. Before, after and in the middle of the treatment sessions all patients will be clinically, neurophysiologically (EEG and EMG) and behaviorally (Kinematics) assessed to verify neural plasticity and motor recovery.
The follow-up at 2 months later will be carried out to assess retention of effects.
Experimental design aim 3:
The health policy to develop appropriate home-based rehabilitation programs for chronic stroke patients (24,25) could induce to explore whether AOT can meet the necessary translational requirements also for this type of care. A New group of 20 chronic stroke patients will be recruited and randomly assigned to the EG OR CG to follow the optimized AOT rehabilitation programs.
After appropriate training of patients and caregivers, the use of tablets will let the home-based treatment. The investigators will define a low-cost highly accessible system based on tablet consumer technology for facilitating the AOT. In particular a tablet will be proposed with a web-based program that will be used to train the patients and receive a feedback of their progress.
The whole treatment period will last 6 weeks. The focus of this evaluation will be on the feasibility of the home-based treatment and the usability of the platform as well as the subjects satisfaction with the services. A preliminary estimate of the recovery and overall improvement of functional performances of participants will also be provided with respect to clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (EG) | Experimental | Other: Action Observation TreatrmentThe Experimental Group (EG) will observe and execute/repeat Activities of Daily Living (ADL) actions. |
| Control Group (CG) | Active comparator | Other: Observation of videos with Non Motor contentsThe COntrol Group (CG) will observe landscapes and perform the same actions observed by their peers but after verbal instructions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Observation TreatrmentAlso: AOTParticipants 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. | Other | Experimental Group (EG) |
| Observation of videos with Non Motor contentsAlso: NMOParticipants 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. | Other | Control Group (CG) |
Primary outcome
Change in Fugl-Meyer (FM) Test
Time frame: 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)
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.
1 secondary outcome
Change in Frenchay Arm Test (FAT)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Background: PubMed 17868935Gosman-Hedstrom G, Claesson L, Blomstrand C. Consequences of severity at stroke onset for health-related quality of life (HRQL) and informal care: a 1-year follow-up in elderly stroke survivors. Arch Gerontol Geriatr. 2008 Jul-Aug;47(1):79-91. doi: 10.1016/j.archger.2007.07.006. Epub 2007 Sep 14.
- Background: PubMed 21901720Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD008349. doi: 10.1002/14651858.CD008349.pub2.
- Background: PubMed 25387001Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, van Wijck F. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2.
- Background: PubMed 21051765Michielsen ME, Selles RW, van der Geest JN, Eckhardt M, Yavuzer G, Stam HJ, Smits M, Ribbers GM, Bussmann JB. Motor recovery and cortical reorganization after mirror therapy in chronic stroke patients: a phase II randomized controlled trial. Neurorehabil Neural Repair. 2011 Mar-Apr;25(3):223-33. doi: 10.1177/1545968310385127. Epub 2010 Nov 4.
- Background: PubMed 17499164Ertelt D, Small S, Solodkin A, Dettmers C, McNamara A, Binkofski F, Buccino G. Action observation has a positive impact on rehabilitation of motor deficits after stroke. Neuroimage. 2007;36 Suppl 2:T164-73. doi: 10.1016/j.neuroimage.2007.03.043. Epub 2007 Mar 31.
- Background: PubMed 20414184Franceschini M, Agosti M, Cantagallo A, Sale P, Mancuso M, Buccino G. Mirror neurons: action observation treatment as a tool in stroke rehabilitation. Eur J Phys Rehabil Med. 2010 Dec;46(4):517-23. Epub 2010 Apr 23.
- Background: PubMed 22235059Franceschini M, Ceravolo MG, Agosti M, Cavallini P, Bonassi S, Dall'Armi V, Massucci M, Schifini F, Sale P. Clinical relevance of action observation in upper-limb stroke rehabilitation: a possible role in recovery of functional dexterity. A randomized clinical trial. Neurorehabil Neural Repair. 2012 Jun;26(5):456-62. doi: 10.1177/1545968311427406. Epub 2012 Jan 10.
- Background: PubMed 22765352Buccino G, Arisi D, Gough P, Aprile D, Ferri C, Serotti L, Tiberti A, Fazzi E. Improving upper limb motor functions through action observation treatment: a pilot study in children with cerebral palsy. Dev Med Child Neurol. 2012 Sep;54(9):822-8. doi: 10.1111/j.1469-8749.2012.04334.x. Epub 2012 Jul 6.
- Background: PubMed 24642381Brunner IC, Skouen JS, Ersland L, Gruner R. Plasticity and response to action observation: a longitudinal FMRI study of potential mirror neurons in patients with subacute stroke. Neurorehabil Neural Repair. 2014 Nov-Dec;28(9):874-84. doi: 10.1177/1545968314527350. Epub 2014 Mar 18.
- Background: PubMed 8800951Gallese V, Fadiga L, Fogassi L, Rizzolatti G. Action recognition in the premotor cortex. Brain. 1996 Apr;119 ( Pt 2):593-609. doi: 10.1093/brain/119.2.593.
- Background: PubMed 15860620Fogassi L, Ferrari PF, Gesierich B, Rozzi S, Chersi F, Rizzolatti G. Parietal lobe: from action organization to intention understanding. Science. 2005 Apr 29;308(5722):662-7. doi: 10.1126/science.1106138.
- Background: PubMed 19805419Bonini L, Rozzi S, Serventi FU, Simone L, Ferrari PF, Fogassi L. Ventral premotor and inferior parietal cortices make distinct contribution to action organization and intention understanding. Cereb Cortex. 2010 Jun;20(6):1372-85. doi: 10.1093/cercor/bhp200. Epub 2009 Oct 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Infarinato, Phd study chair
IRCSS San Raffaele Pisana
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Treatrment and Observation of videos with Non Motor contents in people with Chronic Stroke, run by IRCCS San Raffaele at 2 sites 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Infarinato, Phd (+39065225 ext. 3788, francesco.infarinato@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer (FM) Test (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04047134, which also lists 31 linked publications.
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 3 Aug 2022.