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NCT Number: NCT06859229

New Technological Pathway for Gait Rehabilitation

**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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Centro Neurolesi Bonino-Pulejo

Messina, Maine, 98124, Italy

Location contact

Rocco Salvatore Calabrò, MD, PhD

CONTACT

[email protected]

+3909060128179

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Robotic rehabilitation, virtual reality rehabilitation

Conventional gait rehabilitation strategy

Other

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 names: Gait rehabilitation, conventional neurorehabilitation

Primary outcomes

  1. Neural correlates of movement

    Time frame: 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 outcomes

  1. Neurophysiological outcome

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mirjam Bonanno, PT, MSc

CONTACT

[email protected]

+3909060128179

Rocco Salvatore Calabrò, MD, PhD

CONTACT

[email protected]

+3909060128179

Sponsors and collaborators

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Other

Registry information

Official study title

Effects on Gait Patterns of a New Technological Pathway for Gait Rehabilitation in Patients With Movement Disorders

Acronym: LABODIMOTO

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 5, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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