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New Technological Pathway for Gait Rehabilitation

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06859229
Acronym
LABODIMOTO
Enrollment
60
Registered
2025-03-05
Start date
2025-03-31
Completion date
2027-02-28
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Neurological Diseases or Conditions, Neuromuscular Disease

Keywords

neurorehabilitation, gait rehabilitation, analysis of movement, neuroplasticity

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.

Interventions

DEVICEInnovative 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.

OTHERConventional 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

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 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.

Design outcomes

Primary

MeasureTime frameDescription
Neural correlates of movementFrom enrollment to end of treatment at five weeksWe 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

MeasureTime frameDescription
Neurophysiological outcomeFrom enrollment to end of treatment at five weeksA 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.

Countries

Italy

Contacts

Primary ContactRocco Salvatore Calabrò, MD, PhD
roccos.calabro@irccsme.it+3909060128179
Backup ContactMirjam Bonanno, PT, MSc
mirjam.bonanno@irccsme.it+3909060128179

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026