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

Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System: an Observational Longitudinal Study

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

Study Overview

• Status: Recruiting
• Conditions: Stroke; Multiple Sclerosis; Parkinson Disease; Acquired Brain Injury
• Intervention / Treatment: Device: Robotic Assisted Gait Training with G-EO system

Detailed Description

In recent years, robotic devices have been used to assist balance and gait rehabilitation of people with neurological disorders. In particular, the G-EO system (Reha Technology AG, Switzerland) is a robotic end-effector device guiding the movement of the feet. It is currently unclear which variables are the predictors of treatment success. Indeed, the effectiveness of the GEO treatment may depends on the characteristics of the treatment itself (instrumental parameters defined by the physiotherapist using the device) and on the characteristics of the subject receiving the treatment. Therefore, it is necessary to measure these clinical and instrumental characteristics to understand which are predictors of treatment effects. Parameters obtained from this assessment can be used to elaborate statistical models. In our study the statistical model will be defined as follows: The change in the primary outcome measure after the robotic treatment will be considered as dependent variable of the model. All the "secondary" clinical outcome measures will be measured only at T0 and will be considered in the model as independent variables, along with the participants characteristics (age, gender, disease, disease duration, falls number, numbers of comorbidity, type of hospitalization) and the treatment characteristics (sessions number, frequency, duration, step length, cadence, gait speed, body weight support, distance traveled). The results of the model will suggest which subjects are most responsive to this type of treatment and which variables can be considered as predictors of the treatment success.

• Study Type: Observational
• Enrollment (Anticipated): 260

Contacts and Locations

• Study Contact: Name: Davide Cattaneo, PhD; Phone Number: +39 3383891807; Email: dcattaneo@dongnocchi.it
• Study Contact Backup: Name: Thomass Bowman, PhD; Phone Number: +39 3421887275; Email: tbowman@dongnocchi.it

Study Locations

• Italy
  • Milan, Italy, 20148
    • Recruiting
    • Don Gnocchi Foundation
    • Contact: Davide Cattaneo, PhD; Phone Number: +39 3383891807; Email: dcattaneo@dongnocchi.it
    • Contact: Thomas Bowman, PhD; Phone Number: +39 3421887275; Email: tbowman@dongnocchi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trunk control	The Trunk Control Test can be used to assess the motor impairment of the trunk in a patient, the total score range is 0 (minimum) to 100 (maximum, indicating better performance)	baseline (T0)
Mobility	The Modified Rivermead Mobility Index (MRMI) is recommended to assess mobility in neurological patients. the total score range is 0 (minimum) to 40 (maximum, indicating better mobility)	baseline (T0)
Strength	The 5 time sit to stand test asses functional lower extremity strength, transitional movements, balance, and fall risk in older adults and patient population. The time to stand up and sit down 5 times is measured. Lower time indicates better performance.	baseline (T0)
Walking Endurance	The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. the distance covered in 6 minutes is measured. Greater distance indicates better performance.	baseline (T0)
Walking ability	The modified Dynamic Gait Index (mDGI) measures the capacity to adapt gait to complex tasks utilizing 8 tasks and 3 facets of performance. The total score range is 0 (minimum) to 64 (maximum, indicating better performance)	baseline (T0)
Activities of daily living	The Modified Barthel Index (MBI) is a Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. The total score range is 0 (minimum) to 100 (maximum, indicating no assistance required to complete daily activities)	baseline (T0)
Cognitive function	The Frontal Assessment Battery (FAB) is a brief tool that can be used at the bedside or in a clinic setting to assist in discriminating between dementias with a frontal dysexecutive phenotype and Dementia of Alzheimer"s Type. The total score range is 0 (minimum) to 18 (maximum, indicating better performance)	baseline (T0)
Balance confidence	The Activities-specific Balance confidence (ABC) scale is a questionnaire developed to assess older individual's balance confidence in performing daily activities. ABC scale consists of a wide continuum of less and more challenging daily activities. The total score range is 0 (minimum) to 100 (maximum, indicating better balance confidence in daily activities)	baseline (T0)
Community integration	The Community Integration Questionnaire (CIQ) is a tool used by researchers to gather information about how connected people are to their communities. The total score range is 0 (minimum) to 29 (maximum, indicating greater integration)	baseline (T0)
Gait symmetry (Instrumental index)	Symmetry index of the gait cycle in the AnteroPosterior plan. Higher indexes indicate better performance.	baseline T0
Gait regularity (Instrumental index)	Regularity index of the gait cycle in the AnteroPoserior plan. Higher indexes indicate better performance.	baseline T0

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Anticipated): April 1, 2027
• Study Completion (Anticipated): April 1, 2027

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Stroke; Parkinson Disease; Robotic; Acquired Brain Injury; End-effector
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Wounds and Injuries; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Craniocerebral Trauma; Trauma, Nervous System; Multiple Sclerosis; Sclerosis; Parkinson Disease; Brain Injuries; Nervous System Diseases
• Other Study ID Numbers: 03_06/04/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No