Clinical trial NCT04691102: Predictive Indices of Independent Activity of Daily-living in Neurorehabilitation
Official title: Dynamic Postural Stability Assessment in Neurorehabilitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Brain Injuries
Mild Cognitive Impairment
Parkinson Disease
Multiple Sclerosis
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Six different populations will be considered in the present study:

1. Stroke population
2. Traumatic Brain Injury population
3. Mild Cognitive Impairment population
4. Parkinson Disease population
5. Multiple Sclerosis population
6. Healthy subjects population

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 (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.


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)

Primary outcomes:
measure: Inertial sensors-based assessment
timeFrame: Baseline
Secondary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: Baseline
measure: Dynamic Gait Index (DGI)
timeFrame: Baseline
measure: Balance Evaluation System Test (Mini-BESTest)
timeFrame: Baseline
measure: Electroencephalography (EEG)
timeFrame: Baseline
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Santa Lucia Foundation I.R.C.C.S.
state: Rm
Study officials:
References: