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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05493514
• Other study ID #: 03_06/04/2022
• Status: Recruiting
• Start date: May 13, 2022
• Est. completion date: April 1, 2027

Study information

• Verified date: June 2022
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Davide Cattaneo, PhD
• Phone: 3383891807
• Email: dcattaneo[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Multiple Sclerosis
• Nervous System Diseases
• Parkinson Disease
• Sclerosis
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Italy	Don Gnocchi Foundation	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Gait symmetry (Instrumental index)	Symmetry index of the gait cycle in the AnteroPosterior plan. Higher indexes indicate better performance.	baseline T0
Secondary	Gait regularity (Instrumental index)	Regularity index of the gait cycle in the AnteroPoserior plan. Higher indexes indicate better performance.	baseline T0