- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04691102
Predictive Indices of Independent Activity of Daily-living in Neurorehabilitation
Dynamic Postural Stability Assessment in Neurorehabilitation
Study Overview
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Rm
-
Roma, Rm, Italy, 00179
- Recruiting
- Santa Lucia Foundation I.R.C.C.S.
-
Contact:
- Marco Tramontano
- Phone Number: 0651501420
- Email: m.tramontano@hsantalucia.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Six different populations will be considered in the present study:
- Stroke population
- Traumatic Brain Injury population
- Mild Cognitive Impairment population
- Parkinson Disease population
- Multiple Sclerosis population
- Healthy subjects population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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
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. |
Mild Cognitive Impairment 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. |
Parkinson Disease 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. |
Multiple Sclerosis 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. |
Healthy subjects groups
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inertial sensors-based assessment
Time Frame: Baseline
|
Set of seven magneto-inertial sensors (Opal, APDM Inc., Portland, Oregon, USA).
Gait quality indices related to dynamic stability, symmetry and smoothness will be extracted from the sensors' signals after the execution of a 10-Meter-Walk (10MWT), Figure-of-8-Walk (F8WT), and Fukuda-Stepping test (FST)
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg Balance Scale (BBS)
Time Frame: Baseline
|
The Berg Balance Scale (BBS) is a 14-item objective measure that assess static balance and fall risk.
The BBS values ranging from 0 to 56, where 0 means the worse outcome and the 56 the best one.
|
Baseline
|
Dynamic Gait Index (DGI)
Time Frame: Baseline
|
The Dynamic Gait Index (DGI) allows to assess the dynamic stability during march.
The DGI values ranging from 0 to 24, where 0 means the worse outcome and 24 the best one.
|
Baseline
|
Balance Evaluation System Test (Mini-BESTest)
Time Frame: Baseline
|
The Balance Evaluation System Test (Mini-BESTest) allows to assess the dynamic balance.
It is a 14-item test scored on 3-level ordinal scale.
The Mini-BESTest values ranging from 0 to 28, where 0 means the worse outcome and 28 the best one
|
Baseline
|
Electroencephalography (EEG)
Time Frame: Baseline
|
A portable and low-weight 128-EEG channels system will be use in order to obtain neural predictors of gain stability during walking in the real-world and to distinguish types of walking.
Briefly, source-space EEG signals (based on the individual anatomical image) will be reconstruct to estimate activity (e.g., power spectrum density-PSD) and connectivity (via FC correlation) at rest and during motor tasks
|
Baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Wounds and Injuries
- Neurocognitive Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Cognition Disorders
- Multiple Sclerosis
- Parkinson Disease
- Brain Injuries
- Cognitive Dysfunction
Other Study ID Numbers
- Prot. CE/PROG.877
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey