Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System

NCT05493514 | Recruiting

• 1 other identifier: 03_06/04/2022
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this work is to elaborate a statistical model to predict the effectiveness of robotic treatment in subjects with neurological diseases. The model will be used to understand which subjects are most responsive to this type of treatment

Conditions

Multiple Sclerosis; Stroke; Parkinson Disease; Acquired Brain Injury

Keywords

Multiple Sclerosis; Stroke; Parkinson Disease; Acquired Brain Injury; Robotic; End-effector

Outcome Measures

Primary Outcomes (1)

• Change in gait speed

  The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. The time to cover 6 meters is measured and the walking speed is calculated. higher speed indicates better performance.

  baseline (T0), at the end of the treatment in accordance with the duration foreseen by the therapeutic plan of each subject up to a minimum of 2 weeks, (T1) and 2 months of follow up

Secondary Outcomes (11)

• Trunk control

  baseline (T0)

• Mobility

  baseline (T0)

• Strength

  baseline (T0)

• Walking Endurance

  baseline (T0)

• Walking ability

  baseline (T0)

Study Arms (1)

People with neurological disease according to inclusion criteria

People with neurological disease (Multiple Sclerosis, Parkinson Disease, Stroke and acquired brain injuries) will be recruited according to inclusion and exclusion criteria.

Device: Robotic Assisted Gait Training with G-EO system

Interventions

Robotic Assisted Gait Training with G-EO system DEVICE

Robotic-assisted gait training is a rehabilitation treatment that applies robotic technologies to improve mobility of patients with stroke or other neurological disorders. In this study, participants will use the G-EO system robotic device according to the daily clinical practice of the Don Gnocchi Foundation.

People with neurological disease according to inclusion criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with Neurological Disease, in particular people with Multiple Sclerosis (MS), Parkinson Disease (PD) and Stroke

You may qualify if:

• Diagnosis of Multiple Sclerosis, Parkinson Disease, Stroke or acquired brain injury
• Minimum number of sessions: 10 sessions with the GEO system
• Minimum frequency of sessions: 2 per week
• Age ≥ 18 years
• Ability to walk for at least 10 meters, also with aid
• Indication of robotic treatment in the therapeutic plan
• Body size suitable for the robotic device
• ability to maintain verticality for 7 minutes;
• ability to maintain the sitting position without support for 30 seconds;

You may not qualify if:

• severe limitations of articular range of motion;
• medical problems compromising walking (e.g. fractures, pain, severe osteoporosis or severe spasticity);
• Presence of skin lesions in the areas of contact with the device;
• Presence of seizures that may be triggered by the use of the G-EO system.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Don Gnocchi Foundation

Milan, 20148, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Stroke; Parkinson Disease; Brain Injuries

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Davide Cattaneo, PhD

CONTACT

3383891807; dcattaneo@dongnocchi.it

Thomass Bowman, PhD

CONTACT

3421887275; tbowman@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: August 9, 2022
• Study Start: May 13, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 9, 2022

Record last verified: 2022-06

Locations

IT (1)