New Technological Pathway for Gait Rehabilitation

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06859229
• Lead Sponsor: IRCCS Centro Neurolesi Bonino Pulejo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-23
• Status Verified: 2025-02
• Study Start: 2025-03
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-10
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Neurophysiological outcome	From enrollment to end of treatment at five weeks	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.

Trial Locations

Locations (1)

IRCCS Centro Neurolesi Bonino-Pulejo; 🇮🇹 Messina, Maine, Italy