Multiple SclerosisNCT05493514
Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System
An observational study of Multiple Sclerosis and Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Stroke, Parkinson Disease
- What is being tested?
- Robotic Assisted Gait Training with G-EO system
- Type of treatment
- Medical device
- How many people
- 260 participants
- Where
- 1 siteItaly
- Study dates
- 13 May 2022to 1 Apr 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with Neurological Disease, in particular people with Multiple Sclerosis (MS), Parkinson Disease (PD) and Stroke
Who may be able to join
- 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
Show all 9Show fewer
- 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;
Who cannot join
- 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.
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, 1 recruiting
- Recruiting
Don Gnocchi Foundation
Milan, 20148
Davide Cattaneo, PhD, 3383891807 ext. +39, dcattaneo@dongnocchi.it
Thomas Bowman, PhD, 3421887275 ext. +39, tbowman@dongnocchi.it
About this study
Official title: 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
Read the 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.
- Conditions
- Multiple Sclerosis, Stroke, Parkinson Disease, Acquired Brain Injury
- Being tested
- Robotic Assisted Gait Training with G-EO system
- Keywords
- Multiple Sclerosis, Stroke, Parkinson Disease, Acquired Brain Injury, Robotic, End-effector
- Medical subject headings
- Multiple Sclerosis, Stroke, Parkinson Disease, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assisted Gait Training with G-EO systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Robotic Assisted Gait Training with G-EO system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: baseline (T0)
Gait symmetry (Instrumental index)
Symmetry index of the gait cycle in the AnteroPosterior plan. Higher indexes indicate better performance.
Measured: baseline T0
Gait regularity (Instrumental index)
Regularity index of the gait cycle in the AnteroPoserior plan. Higher indexes indicate better performance.
Measured: baseline T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start13 May 2022
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493514
- Sponsor's protocol ID
- 03_06/04/2022
- Status last verified
- Jun 2022
- First submitted
- 21 Jul 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System: an Observational Longitudinal Study
- ClinicalTrials.gov ID
- NCT05493514
- Acronym / sponsor ID
- 03_06/04/2022
- Conditions
- Multiple Sclerosis, Stroke, Parkinson Disease, Acquired Brain Injury
- Keywords
- Multiple Sclerosis, Stroke, Parkinson Disease, Acquired Brain Injury, Robotic, End-effector
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 9 Aug 2022 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with neurological disease according to inclusion criteria | – | Device: Robotic Assisted Gait Training with G-EO systemPeople with neurological disease (Multiple Sclerosis, Parkinson Disease, Stroke and acquired brain injuries) will be recruited according to inclusion and exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with Neurological Disease, in particular people with Multiple Sclerosis (MS), Parkinson Disease (PD) and Stroke
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Robotic Assisted Gait Training with G-EO systemRobotic-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. | Device | People with neurological disease according to inclusion criteria |
Primary outcome
Change in gait speed
Time frame: 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.
11 secondary outcomes
Trunk control
Time frame: baseline (T0)
Mobility
Time frame: baseline (T0)
Strength
Time frame: baseline (T0)
Walking Endurance
Time frame: baseline (T0)
Walking ability
Time frame: baseline (T0)
Activities of daily living
Time frame: baseline (T0)
Cognitive function
Time frame: baseline (T0)
Balance confidence
Time frame: baseline (T0)
Community integration
Time frame: baseline (T0)
Gait symmetry (Instrumental index)
Time frame: baseline T0
Gait regularity (Instrumental index)
Time frame: baseline T0
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 9 Aug 2022.
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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?
An observational study of Multiple Sclerosis and Stroke, run by Fondazione Don Carlo Gnocchi ETS 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 9 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: looking for participants now, as of the sponsor's last update on 9 Aug 2022. 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 Davide Cattaneo, PhD (3383891807 ext. +39, dcattaneo@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait speed (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2022.