New Technological Pathway for Gait Rehabilitation (LABODIMOTO)

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

**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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Neuromuscular Disease; Neurological Diseases or Conditions
• Intervention / Treatment: Device: Innovative technology pathway for gait neurorehabilitation; Other: Conventional gait rehabilitation strategy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rocco Salvatore Calabrò, MD, PhD; Phone Number: +3909060128179; Email: roccos.calabro@irccsme.it
• Study Contact Backup: Name: Mirjam Bonanno, PT, MSc; Phone Number: +3909060128179; Email: mirjam.bonanno@irccsme.it

Study Locations

• Italy
  • Maine
    • Messina, Maine, Italy, 98124
      • IRCCS Centro Neurolesi Bonino-Pulejo
      • Contact: Rocco Salvatore Calabrò, MD, PhD; Phone Number: +3909060128179; Email: roccos.calabro@irccsme.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Innovative gait rehabilitation pathway; The group will be treated with a dynamic pathway with advanced technology for gait rehabilitation.	Device: Innovative 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.; Other Names: Robotic rehabilitation; virtual reality rehabilitation
Active Comparator: Conventional gait rehabilitation; The group will be treated with conventional gait rehabilitation strategies.	Other: Conventional 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; Other Names: Gait rehabilitation; conventional neurorehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment to end of treatment at five weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to end of treatment at five weeks

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi Bonino Pulejo

Publications and helpful links

General Publications

• Hornby TG, Campbell DD, Kahn JH, Demott T, Moore JL, Roth HR. Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study. Stroke. 2008 Jun;39(6):1786-92. doi: 10.1161/STROKEAHA.107.504779. Epub 2008 May 8. Erratum In: Stroke.2008 Aug;39(8): e143.
• Chang WH, Kim YH. Robot-assisted Therapy in Stroke Rehabilitation. J Stroke. 2013 Sep;15(3):174-81. doi: 10.5853/jos.2013.15.3.174. Epub 2013 Sep 27.
• Hidler J, Nichols D, Pelliccio M, Brady K, Campbell DD, Kahn JH, Hornby TG. Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in subacute stroke. Neurorehabil Neural Repair. 2009 Jan;23(1):5-13. doi: 10.1177/1545968308326632.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: neuroplasticity; gait rehabilitation; neurorehabilitation; analysis of movement
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: 45/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No