New Technological Pathway for Gait Rehabilitation (LABODIMOTO)

IRCCS Centro Neurolesi Bonino Pulejo

Status: Not yet enrolling

Conditions: Cardiovascular Diseases; Neuromuscular Disease; Neurological Diseases or Conditions

Treatments: Other: Conventional gait rehabilitation strategy; Device: Innovative technology pathway for gait neurorehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06859229

45/2020

Details and patient eligibility

About

**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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Innovative gait rehabilitation pathway

Experimental group

Description:

The group will be treated with a dynamic pathway with advanced technology for gait rehabilitation.

Treatment:

Device: Innovative technology pathway for gait neurorehabilitation

Conventional gait rehabilitation

Active Comparator group

Description:

The group will be treated with conventional gait rehabilitation strategies.

Treatment:

Other: Conventional gait rehabilitation strategy