Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT04691102
Eligibility 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)
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
85 Years
Study:
NCT04691102
Study Brief:
Protocol Section:
NCT04691102