New Technological Pathway for Gait Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Innovative technology pathway for gait neurorehabilitation, Conventional gait rehabilitation strategy.
- Who it may be relevant to
- Registry conditions: Neurological Diseases or Conditions, Cardiovascular Diseases, Neuromuscular Disease. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects on Gait Patterns of a New Technological Pathway for Gait Rehabilitation in Patients With Movement Disorders
Overview
\*\*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
- 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 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
Primary outcome measures
- Neural correlates of movement [Time frame: From enrollment to end of treatment at five weeks]
Secondary outcome measures (1)
- Neurophysiological outcome [Time frame: From enrollment to end of treatment at five weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- IRCCS Centro Neurolesi Bonino-Pulejo — Messina
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT06859229 · 45/2020