Patient-therapist INTERaction During RObotic GAIT Rehabilitation After Spinal Cord Injury
NCT ID: NCT06531304
Last Updated: 2024-07-31
Study Results
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Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-06-05
2025-05-31
Brief Summary
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Detailed Description
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Recent data on human-to-human interactions and neural correlates of interpersonally coordinated motor behavior have indicated that cooperative motor behavior engages specific cortical and subcortical areas of the motor system compared with execution of the task alone, promoting the learning of motor strategies to support recovery. Recently, a new conceptual and methodological framework has been proposed to investigate the neural basis of human social interaction: the two-person neuroscience. It focuses on studying the dual exchange rather than only on the individual behavior, by using simultaneous neurophysiological recordings from two or more subjects, commonly referred to as hyperscanning or dual scanning. An approach that can provide a viable way to untangle the social interaction from two-persons data is multiple-brain connectivity (also referred to, in some studies, as hyperconnectivity). Thereby temporal correlations between signals derived from the brain regions of different subjects during their interaction are studied to understand how the brain activity of each subject is correlated to the activity in the brain of the other subject. Inter-subject connectivity was described by fMRI, MEG and EEG studies, the latter allowing for an ecological setting. Furthermore, the use of indices derived from graph theory allows to characterize the multiple brain system by means of its properties. The literature is vast on the effects of RAGT on i-SCI gait performances, particularly on speed parameters. However the impact of Pht-Pt interaction on gait outcome has never been investigated in this context at the time of this proposal. The combination of EEG hyperscanning and multiple-brain connectivity could be a powerful tool to objectively measure the Pht-Pt interaction and put it in relation with the rehabilitation outcomes. INTERROGAIT will explore such context by modulating Pht-Pt interaction during gait rehabilitation with the Lokomat device in iSCI patients.
The main hypothesis is that RAGT performed using the FB provided the Lokomat device with an high level of Pht-Pt interaction can lead to a better functional outcome for Pts, in comparison to a minimum interaction. Moreover, we will provide quantitative assessment of Pht-Pt interaction (EEG hyperscanning study) and seek for correlations between neurophysiological descriptors and clinical outcome, supporting our main hypothesis.
The main aim of this study is to test the effects of maximum and minimum PhT-Pt interaction in RAGT on clinical and functional performences in iSCI subjects, through a single blind longitudinal randomized controlled clinical trial.
Furthermore, the study will be aimed to identify neurophysiological indices derived from hyperscanning EEG data monitoring the establishment and development of Pht-Pt interaction during RAGT and to investigate the correlation between the establishment of a successful Pht-Pt interaction as assessed via neurophysiological indices and psychological variables and the rehabilitation outcome. Aspects related to acceptability and usability of the approaches will be evaluated. In detail for the Pt mood, motivation and satisfaction will be evaluated before (mood, motivation) and after (satisfaction) RAGT sessions by means of Visual Analogue Scales; workload will be evaluated at the end of the training sessions by means of the Nasa-Task Load Index. For both Pht and Pt the empathy and the ability to recognize or express emotion will be assesses before and after the training according to Emotional Response Scale, Impression Scale, Interpersonal Reactivity Index,Empathy Quotient, Assertion Inventory, Responsibility Attitude Scale.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Data analysis (EEG, EMG, Kinematic, Kientic) will be performed by neuroscientists blinded to group allocation.
Study Groups
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EXP GROUP
Patients will receive visual FB information about the Lokomat joint torque on the screen in front of him/her in order to adapt on-line hips and knees performances. In the EXP group, the Physical Therapist will receives also visual FB information and will guide the patient along the sessions with continuos verbal instructions, thus optimizing the PhT-Pt interaction with an high level of interaction. Patient will be asked to modify his/her hips or knees performances according to both the FB visualized on the screen and the information provided by the PhT.
Lokomat Robot Assisted Gait Training
Patients will underwent 12 RAGT training sessions (3 times/week for 4 consecutive weeks, 45 min each including the time for wearing the harness and the exoskeleton) with the Lokomat device as add-on to conventional regimen (5 times/week, 80 min each). The Lokomat is a technologically advanced robot-assisted gait training device. Patients are supported in a harness above a treadmill while the robotic device assists the movements of their legs to provide physiological gait. As treatment progresses, weight bearing is increased and assistance from the robotic legs is reduced, requiring the patient to gradually assume greater responsibility for movements needed during walking.
CTRL GROUP
Patients will receive visual FB information about the Lokomat joint torque on the screen in front of him/her in order to adapt on-line hips and knees performances, but the level on interaction between Patient and Physical Therapist will be reduced to its minimum because of no verbal instruction provided by the Physical Therapist to the patient. Consequently, patient will be asked to modify his/her hips or knees performances according only to the FB visualized on the screen, without no technical exchange with the Physical Therapist.
Lokomat Robot Assisted Gait Training
Patients will underwent 12 RAGT training sessions (3 times/week for 4 consecutive weeks, 45 min each including the time for wearing the harness and the exoskeleton) with the Lokomat device as add-on to conventional regimen (5 times/week, 80 min each). The Lokomat is a technologically advanced robot-assisted gait training device. Patients are supported in a harness above a treadmill while the robotic device assists the movements of their legs to provide physiological gait. As treatment progresses, weight bearing is increased and assistance from the robotic legs is reduced, requiring the patient to gradually assume greater responsibility for movements needed during walking.
Interventions
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Lokomat Robot Assisted Gait Training
Patients will underwent 12 RAGT training sessions (3 times/week for 4 consecutive weeks, 45 min each including the time for wearing the harness and the exoskeleton) with the Lokomat device as add-on to conventional regimen (5 times/week, 80 min each). The Lokomat is a technologically advanced robot-assisted gait training device. Patients are supported in a harness above a treadmill while the robotic device assists the movements of their legs to provide physiological gait. As treatment progresses, weight bearing is increased and assistance from the robotic legs is reduced, requiring the patient to gradually assume greater responsibility for movements needed during walking.
Eligibility Criteria
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Inclusion Criteria
* subacute or chronic iSCI;
* traumatic and non-traumatic aetiology;
* SCI at or above T12 level;
* absence of severe cognitive impairment such as to interfere with the protocol.
Exclusion Criteria
* anything preventing EEG recording.
18 Years
85 Years
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
I.R.C.C.S. Fondazione Santa Lucia
OTHER
Responsible Party
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Federica Tamburella
Associate Professor, PhT, PhD
Principal Investigators
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Federica Tamburella
Role: PRINCIPAL_INVESTIGATOR
I.R.C.C.S. Fondazione Santa Lucia
Locations
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I.R.C.C.S. Fondazione Santa Lucia
Roma, Rome, Italy
Countries
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Central Contacts
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Facility Contacts
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Federica Tamburella, Professor
Role: primary
References
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Tamburella F, Moreno JC, Herrera Valenzuela DS, Pisotta I, Iosa M, Cincotti F, Mattia D, Pons JL, Molinari M. Influences of the biofeedback content on robotic post-stroke gait rehabilitation: electromyographic vs joint torque biofeedback. J Neuroeng Rehabil. 2019 Jul 23;16(1):95. doi: 10.1186/s12984-019-0558-0.
Belda-Lois JM, Mena-del Horno S, Bermejo-Bosch I, Moreno JC, Pons JL, Farina D, Iosa M, Molinari M, Tamburella F, Ramos A, Caria A, Solis-Escalante T, Brunner C, Rea M. Rehabilitation of gait after stroke: a review towards a top-down approach. J Neuroeng Rehabil. 2011 Dec 13;8:66. doi: 10.1186/1743-0003-8-66.
Tamburella F, Moreno JC, Iosa M, Pisotta I, Cincotti F, Mattia D, Pons JL, Molinari M. Boosting the traditional physiotherapist approach for stroke spasticity using a sensorized ankle foot orthosis: a pilot study. Top Stroke Rehabil. 2017 Sep;24(6):447-456. doi: 10.1080/10749357.2017.1318340. Epub 2017 May 1.
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Toppi J, Borghini G, Petti M, He EJ, De Giusti V, He B, Astolfi L, Babiloni F. Investigating Cooperative Behavior in Ecological Settings: An EEG Hyperscanning Study. PLoS One. 2016 Apr 28;11(4):e0154236. doi: 10.1371/journal.pone.0154236. eCollection 2016.
Astolfi L, Toppi J, De Vico Fallani F, Vecchiato G, Cincotti F, Wilke CT, Yuan H, Mattia D, Salinari S, He B, Babiloni F. Imaging the Social Brain by Simultaneous Hyperscanning During Subject Interaction. IEEE Intell Syst. 2011 Oct;26(5):38-45. doi: 10.1109/MIS.2011.61. No abstract available.
Astolfi L, De Vico Fallani F, Cincotti F, Mattia D, Marciani MG, Salinari S, Sweeney J, Miller GA, He B, Babiloni F. Estimation of effective and functional cortical connectivity from neuroelectric and hemodynamic recordings. IEEE Trans Neural Syst Rehabil Eng. 2009 Jun;17(3):224-33. doi: 10.1109/TNSRE.2008.2010472. Epub 2008 Dec 9.
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Other Identifiers
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GR-2019-12369207
Identifier Type: -
Identifier Source: org_study_id