New Technological Pathway for Gait Rehabilitation

NCT06859229 | Not Yet Recruiting

• 1 other identifier: 45/2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurological Diseases or Conditions; Cardiovascular Diseases; Neuromuscular Disease

Keywords

neurorehabilitation; gait rehabilitation; analysis of movement; neuroplasticity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Neurophysiological outcome

  From enrollment to end of treatment at five weeks

Study Arms (2)

Innovative gait rehabilitation pathway

EXPERIMENTAL

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

Device: Innovative technology pathway for gait neurorehabilitation

Conventional gait rehabilitation

ACTIVE COMPARATOR

The group will be treated with conventional gait rehabilitation strategies.

Other: Conventional gait rehabilitation strategy

Interventions

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.

Also known as: Robotic rehabilitation, virtual reality rehabilitation

Innovative gait rehabilitation pathway

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

Also known as: Gait rehabilitation, conventional neurorehabilitation

Conventional gait rehabilitation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi Bonino-Pulejo

Messina, Maine, 98124, Italy

Location

Related Publications (3)

• 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.

  PMID: 19109447 BACKGROUND

• 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.

  PMID: 18467648 BACKGROUND

• 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.

  PMID: 24396811 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Central Study Contacts

Rocco Salvatore Calabrò, MD, PhD

CONTACT

+3909060128179; roccos.calabro@irccsme.it

Mirjam Bonanno, PT, MSc

CONTACT

+3909060128179; mirjam.bonanno@irccsme.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: March 5, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 5, 2025

Record last verified: 2025-02

Locations

IT (1)