Status:
UNKNOWN
Predictive Indices of Independent Activity of Daily-living in Neurorehabilitation
Lead Sponsor:
I.R.C.C.S. Fondazione Santa Lucia
Conditions:
Stroke
Brain Injuries
Eligibility:
All Genders
15-85 years
Brief Summary
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 (A...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
May 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04691102
Start Date
May 1 2021
End Date
October 1 2023
Last Update
April 18 2023
Active Locations (1)
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1
Santa Lucia Foundation I.R.C.C.S.
Roma, Rm, Italy, 00179