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New Technological Pathway for Gait Rehabilitation

NCT06859229 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-03
Last updated
2025-03-05

Condition(s) studied

Neurological Diseases or ConditionsCardiovascular DiseasesNeuromuscular Disease

Investigational drug(s) / intervention(s)

Innovative technology pathway for gait neurorehabilitationConventional gait rehabilitation strategy

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

Study summary

\*\*Brief Summary\*\*

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * Patients with a Montreal Cognitive Assessment (MoCA) score, corrected for age and education, equal to or greater than 20. * Subjects capable of walking independently (Functional Ambulation Categories - FAC \> 2). Exclusion Criteria: * Cognitive impairments that compromise the understanding and/or execution of the proposed exercises. * 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.

Primary outcome measure(s)

  • Neural correlates of movement — From enrollment to end of treatment at five weeks
    We will assess motor functions using clinical scales (e.g., Fugl-Meyer Lower Extremity), to explore potential links between gait rehabilitation and motor recovery. Time Frame: Baseline (T0), post-intervention (T1, 12 weeks after baseline), and follow-up (T2, 3 months post-intervention).

Trial sites (1)

FacilityCityRegionStatus
IRCCS Centro Neurolesi Bonino-Pulejo Messina Maine
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06859229 on ClinicalTrials.gov ↗ ← All trials in Italy