Neurological Diseases or ConditionsLABODIMOTONCT06859229
New Technological Pathway for Gait Rehabilitation
A study testing Innovative technology pathway for gait neurorehabilitation and Conventional gait rehabilitation strategy in people with Neurological Diseases or Conditions and Cardiovascular Diseases, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neurological Diseases or Conditions, Cardiovascular Diseases, Neuromuscular Disease
- What is being tested?
- Innovative technology pathway for gait neurorehabilitation and Conventional gait rehabilitation strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Centro Neurolesi Bonino-Pulejo
Messina, Maine, 98124
Rocco Salvatore Calabrò, MD, PhD, +3909060128179, roccos.calabro@irccsme.it
About this study
Official title: 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.
Read more
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.
- Being tested
- Innovative technology pathway for gait neurorehabilitation, Conventional gait rehabilitation strategy
- Keywords
- neurorehabilitation, gait rehabilitation, analysis of movement, neuroplasticity
- Medical subject headings
- Cardiovascular Diseases, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative technology pathway for gait neurorehabilitationDevice
Also called Robotic rehabilitation, virtual reality rehabilitation
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.
Conventional gait rehabilitation strategyOther
Also called Gait rehabilitation, conventional neurorehabilitation
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
| Study group | Role | What they receive |
|---|---|---|
| Innovative gait rehabilitation pathway | Experimental | The group will be treated with a dynamic pathway with advanced technology for gait rehabilitation. Receives: Device: Innovative technology pathway for gait neurorehabilitation |
| Conventional gait rehabilitation | Active comparator | The group will be treated with conventional gait rehabilitation strategies. Receives: Other: Conventional gait rehabilitation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to end of treatment at five weeks
Secondary outcomes (1)
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.
Measured: From enrollment to end of treatment at five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neurological Diseases or ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859229
- Sponsor's protocol ID
- 45/2020
- Acronym
- LABODIMOTO
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 19109447Hornby 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.
PubMed 18467648Chang 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.
PubMed 24396811
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Gait Patterns of a New Technological Pathway for Gait Rehabilitation in Patients With Movement Disorders
- ClinicalTrials.gov ID
- NCT06859229
- Acronym / sponsor ID
- LABODIMOTO / 45/2020
- Keywords
- neurorehabilitation, gait rehabilitation, analysis of movement, neuroplasticity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Innovative gait rehabilitation pathway | Experimental | Device: Innovative technology pathway for gait neurorehabilitationThe group will be treated with a dynamic pathway with advanced technology for gait rehabilitation. |
| Conventional gait rehabilitation | Active comparator | Other: Conventional gait rehabilitation strategyThe group will be treated with conventional gait rehabilitation strategies. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Innovative technology pathway for gait neurorehabilitationAlso: Robotic rehabilitation, virtual reality rehabilitationParticipants 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. | Device | Innovative gait rehabilitation pathway |
| Conventional gait rehabilitation strategyAlso: Gait rehabilitation, conventional neurorehabilitationThe 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 | Conventional gait rehabilitation |
Primary outcome
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).
1 secondary outcome
Neurophysiological outcome
Time frame: From enrollment to end of treatment at five weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Results publication: PubMed 19109447Hidler 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.
- Results publication: PubMed 18467648Hornby 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.
- Results publication: PubMed 24396811Chang 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.
- Individual participant dataSharing planned: Undecided
Related trials for Neurological Diseases or Conditions
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovative technology pathway for gait neurorehabilitation and Conventional gait rehabilitation strategy in people with Neurological Diseases or Conditions and Cardiovascular Diseases, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rocco Salvatore Calabrò, MD, PhD (+3909060128179, roccos.calabro@irccsme.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural correlates of movement (time frame: From enrollment to end of treatment at five weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06859229, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.