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

Recruiting

• Conditions: Acquired Brain Injury; Stroke; Parkinson Disease; Multiple Sclerosis
• Interventions: Device: Robotic Assisted Gait Training with G-EO system

• Registration Number: NCT05493514
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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

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 Timeline

• Study Start: 2022-05-13
• Status Verified: 2022-06
• Study First Submitted: 2022-07-21
• Study First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Study First Posted: 2022-08-09
• Last Update Posted: 2022-08-09
• Primary Completion: 2027-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
People with neurological disease according to inclusion criteria	Robotic Assisted Gait Training with G-EO system	People with neurological disease (Multiple Sclerosis, Parkinson Disease, Stroke and acquired brain injuries) will be recruited according to inclusion and exclusion criteria.

Primary Outcome Measures

Name	Time	Method
Change in gait speed	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	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.

Secondary Outcome Measures

Name	Time	Method
Cognitive function	baseline (T0)	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)
Walking ability	baseline (T0)	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)
Trunk control	baseline (T0)	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)
Strength	baseline (T0)	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.
Walking Endurance	baseline (T0)	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.
Gait symmetry (Instrumental index)	baseline T0	Symmetry index of the gait cycle in the AnteroPosterior plan. Higher indexes indicate better performance.
Gait regularity (Instrumental index)	baseline T0	Regularity index of the gait cycle in the AnteroPoserior plan. Higher indexes indicate better performance.
Mobility	baseline (T0)	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)
Activities of daily living	baseline (T0)	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)
Balance confidence	baseline (T0)	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)
Community integration	baseline (T0)	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)

Trial Locations

Locations (1)

Don Gnocchi Foundation; 🇮🇹 Milan, Italy