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Predictive Indices of Independent Activity of Daily-living in Neurorehabilitation

Study Purpose

Postural and balance disorders are common in neurological disorders. They are often associated with reduced mobility and fear of falling, which strongly limit independent activities of daily living (ADL), compromise the quality of life and reduce social participation. Here the investigators apply an existing software solution to: 1) obtain biomarkers of gait deficits in 5 neurological conditions, 2) develop an automatic procedure supporting clinicians in the early identification of patients at high risk of falling as to tailor rehabilitation treatment; 3) longitudinally assess these patients to test the efficacy of rehabilitation. High-density electroencephalography (EEG), and inertial sensors located at lower limbs and at upper body levels will be used to extract the most appropriate indexes during motor tasks. The ultimate goal is to develop cost-effective treatment procedures to prevent recurrent falls and fall-related injuries and favour the reintegration of the patient into everyday activities. The first hypothesis of this study is that clinical professionals (e.g., medical doctors and rehabilitative staff) would strongly benefit from the possibility to rely on quantitative, reliable and reproducible information about patients motor deficits. This piece of information can be nowadays readily available through miniaturized wearable technology and its information content can be effectively conveyed thanks to ad hoc software solution, like the A.r.i.s.e. software. The second hypothesis of the present study is that early identification of patients at high risk of dependence and the subsequent application of personalized treatment would allow for cost-effective treatment procedures to favor the autonomy into everyday activities. The results of this project could represent a valuable support in the clinical reasoning and decision-making process.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	15 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria Stroke patients:

- < 6 months from the acute event; - age range 18-85 years; - Functional Ambulation Category (FAC) ≥ 3.

Exclusion Criteria Stroke patients:

- Cognitive deficits (Mini Mental State Examination (MMSE) > 24); - Severe unilateral spatial neglect (diagnosed with Letter Cancellation test, the Barrage test, the Sentence Reading test and the Wundt-Jastrow Area Illusion Test); - Severe aphasia (diagnosed with neuropsychological assessment); - Neurological/orthopedic/cardiac comorbidities (clinically evaluated); - Alcohol or substance abuse.

Inclusion Criteria Traumatic Brain Injury (TBI) patients:

- Glasgow Coma Scale (GCS) ≤ 8; - Age range 15-65years; - Level of Cognitive Functioning (LCF): ≥ 7; - Adequate linguistic abilities; dynamic balance disorders; - Functional Ambulation Category (FAC)≥ 3; Exclusion Criteria Traumatic Brain Injury (TBI) patients.

- Glasgow Coma Scale (GCS) > 8; - Level of Cognitive Functioning (LCF) < 7; - Severe aphasia (based on neuropsychological assessment); - Absence of balance disorders; - Functional Ambulation Category (FAC) < 3.

- Alcohol or substance abuse.

Inclusion Criteria Mild Cognitive Impairment (MCI) patients:

- Age ≥ 60 Years.

- Normal Neurologic Examination.

- Cognitive decline reporting by the patient himself or by the caregiver.

- Mini Mental State Examination (MMSE) score range: 23.88 ≤ MMSE ≤ 26 ( or ≤ 28 if the patient's schooling is up than 16 years.

- Functional Independence.

- Clinical Dementia Rating (CDR) <1.

Exclusion Criteria Mild Cognitive Impairment (MCI) patients:

- Presence of overt dementia.

- Other clinical and/or neurological condition which could compromise the assessment.

- Alcohol or substance abuse.

Inclusion Criteria Parkinson Disease patients (PD):

- Absence of dementia (Mini-Mental State Examination score (MMSE)> 25); - Age range 40-80 years; - Hoehn & Yahr 2-3; - Walking autonomy.

Exclusion Criteria Parkinson Disease patients (PD):

- Dementia (Hoehn & Yahr) > 3; - Severe cardiological / pulmonary / orthopaedic / metabolic conditions that prevent the trial participation; Inclusion Criteria Multiple Sclerosis (MS) patients: - Age range 30-65 years.

- Diagnosis of Multiple Sclerosis (MS) according with revisited McDonalds criteria; - Expanded Disability Status Scale (EDSS) ranging between 0 and 6; - Ability to walk independently or with aid for at least 50 meters.

Exclusion Criteria Multiple Sclerosis (MS) patients:

- Associated psychiatric and/or neurological disorders (different from the MS); - Clinical relapse within the three months prior to enrollment; - Steroid therapy within 30 days before the enrollment; - Peripheric diseases as visual and/or auditory impairments that could interfere with motor and cognitive tasks execution; - Fracture of lower limb within three months before the enrollment.

Inclusion Criteria Healthy subjects:

- Age range 18-80 years.

Exclusion Criteria Healthy subjects: - Any neurological/orthopedic/cardiac condition (clinically evaluated)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04691102
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	I.R.C.C.S. Fondazione Santa Lucia
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Stroke, Brain Injuries, Mild Cognitive Impairment, Parkinson Disease, Multiple Sclerosis

Arms & Interventions

Arms

: Stroke group

Patients will undergo electroencephalography (EEG), electromyography (EMG), electrocardiogram (EKG) and electrooculography (EOG) during resting state and the execution of motor tasks. During the records, an inertial sensors-based assessment will be performed on all patients. Three different motor tasks will be considered for postural and gait functions, commonly adopted in the clinical practice (i.e., 10-Meter-Walk, Figure-of-8-Walk, and Fukuda-Stepping tests). To assess the motor function of upper limb, three different tasks, representative of the typical ADL movements, will be considered (Reach Out, Reach and Touch, Reach and Grasp). Each task will be repeated 3 times. The whole assessment procedure will last approximately 40 minutes.

: Traumatic Brain Injury group

: Mild Cognitive Impairment group

: Parkinson Disease group

: Multiple Sclerosis group

: Healthy subjects groups

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Santa Lucia Foundation I.R.C.C.S., Roma, Rm, Italy

Status

Recruiting

Address

Santa Lucia Foundation I.R.C.C.S.

Roma, Rm, 00179

Site Contact

Marco Tramontano

[email protected]

0651501420

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