New Technological Pathway for Gait Rehabilitation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorIRCCS Centro Neurolesi Bonino Pulejo

About this trial

\*\*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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Innovative technology pathway for gait neurorehabilitation

    Device

    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

    Other intervention

    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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Innovative gait rehabilitation pathwayExperimental treatment 1 intervention
Group B: Conventional gait rehabilitationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Neural correlates of movement

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).

Time frame
From enrollment to end of treatment at five weeks

Secondary outcomes

1

Neurophysiological outcome

A secondary objective is to investigate the neurophysiological changes associated with the intervention. This includes analyzing EEG parameters (such as changes in alpha, theta, and beta rhythms) to understand the underlying mechanisms driving motor improvements.

Time frame
From enrollment to end of treatment at five weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: