Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
People with Neurological Disease, in particular people with Multiple Sclerosis (MS), Parkinson Disease (PD) and Stroke
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Robotic Assisted Gait Training with G-EO system
DeviceRobotic-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.
Treatment groups
260 Participants
are divided into 1 treatment groupGroup A: People with neurological disease according to inclusion criteria1 intervention
Trial outcomes
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.
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 upSecondary outcomes
1
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)
Time frame
baseline (T0)2
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)
Time frame
baseline (T0)3
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.
Time frame
baseline (T0)4
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.
Time frame
baseline (T0)Sponsors and contacts
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Source ClinicalTrials.gov