Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-03-31
2027-02-28
Brief Summary
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The study aims to explore how the integration of visual and motor systems can be trained and enhanced to improve gait rehabilitation in patients with various neurological and cardiovascular conditions. Scientific evidence highlights that physical activity requires coordination and precise processing of visual, auditory, and sensory information from the external environment, which is then integrated at the brain level. This process establishes synaptic connections that direct the movement of arms, hands, legs, and the trunk through bottom-up and top-down mechanisms. However, inaccurate or incomplete perceptual information can impair performance, even when accurate visual stimuli are provided, emphasizing the importance of assessing and enhancing visuo-motor integration.
The research investigates the central mechanisms controlling peripheral muscle activation patterns during gait. While over-ground walking in healthy individuals generally does not activate the prefrontal cortex except in dual-task scenarios, evidence suggests that post-stroke patients exhibit increased prefrontal cortex metabolism during walking. Recent studies have shown that gait training with exoskeletal systems improves walking patterns in post-stroke patients by altering muscle activation patterns and increasing fronto-parietal connectivity.
This study seeks to answer the following question: How do central and peripheral mechanisms interact to influence gait rehabilitation outcomes, and what role do visuo-motor integration and neuroplasticity play in this process? To address this, advanced neuroimaging technologies such as fMRI, dtMRI, and NIRS will be employed to investigate these mechanisms in vivo.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Innovative gait rehabilitation pathway
The group will be treated with a dynamic pathway with advanced technology for gait rehabilitation.
Innovative technology pathway for gait neurorehabilitation
Participants will be assigned to either an advanced or traditional training pathway based on the protocol. The innovative tehcnology pathway for gait rehabilitation will incorporate devices such as exoskeletons, virtual reality systems, and body-weight suspension (BWS) devices to enhance gait rehabilitation. At the end of the training period, participants will undergo follow-up evaluation tests to assess outcomes.
Conventional gait rehabilitation
The group will be treated with conventional gait rehabilitation strategies.
Conventional gait rehabilitation strategy
The control group will undergo a traditional rehabilitation program that follows standard clinical protocols for gait recovery. This program will include conventional therapeutic exercises aimed at improving strength, balance, coordination, and functional mobility
Interventions
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Innovative technology pathway for gait neurorehabilitation
Participants will be assigned to either an advanced or traditional training pathway based on the protocol. The innovative tehcnology pathway for gait rehabilitation will incorporate devices such as exoskeletons, virtual reality systems, and body-weight suspension (BWS) devices to enhance gait rehabilitation. At the end of the training period, participants will undergo follow-up evaluation tests to assess outcomes.
Conventional gait rehabilitation strategy
The control group will undergo a traditional rehabilitation program that follows standard clinical protocols for gait recovery. This program will include conventional therapeutic exercises aimed at improving strength, balance, coordination, and functional mobility
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects capable of walking independently (Functional Ambulation Categories - FAC \> 2).
Exclusion Criteria
* Associated comorbidities that prevent maintaining an upright position or walking (e.g., hypotension).
* Refusal or inability to provide informed consent.
* Patients with contraindications to the use of the technological equipment required for the dynamic movement pathway.
18 Years
60 Years
ALL
No
Sponsors
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IRCCS Centro Neurolesi Bonino Pulejo
OTHER
Responsible Party
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Locations
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IRCCS Centro Neurolesi Bonino-Pulejo
Messina, Maine, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Hidler J, Nichols D, Pelliccio M, Brady K, Campbell DD, Kahn JH, Hornby TG. Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in subacute stroke. Neurorehabil Neural Repair. 2009 Jan;23(1):5-13. doi: 10.1177/1545968308326632.
Hornby TG, Campbell DD, Kahn JH, Demott T, Moore JL, Roth HR. Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study. Stroke. 2008 Jun;39(6):1786-92. doi: 10.1161/STROKEAHA.107.504779. Epub 2008 May 8.
Chang WH, Kim YH. Robot-assisted Therapy in Stroke Rehabilitation. J Stroke. 2013 Sep;15(3):174-81. doi: 10.5853/jos.2013.15.3.174. Epub 2013 Sep 27.
Other Identifiers
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45/2020
Identifier Type: -
Identifier Source: org_study_id
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