StrokeNCT04691102

Predictive Indices of Independent Activity of Daily-living in Neurorehabilitation

An observational study of Stroke and Brain Injuries, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 15 to 85 years
Conditions the study is for: Stroke, Brain Injuries, Mild Cognitive Impairment
How many people: 120 participants
Where: 1 siteItaly
Study dates: 1 May 2021to 1 Oct 2023
How long will I take part?: 1 Day
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 85 years
All sexes
Child, Adult, Older adult

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

Who may be able to join

< 6 months from the acute event;
age range 18-85 years;
Functional Ambulation Category (FAC) ≥ 3.
Glasgow Coma Scale (GCS) ≤ 8;
Age range 15-65years;
Level of Cognitive Functioning (LCF): ≥ 7;

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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
Absence of dementia (Mini-Mental State Examination score (MMSE)> 25);
Age range 40-80 years;
Hoehn \& Yahr 2-3;
Walking autonomy
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.
Age range 18-80 years

Who cannot join

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.
Dementia (Hoehn \& Yahr) > 3;

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Severe cardiological / pulmonary / orthopaedic / metabolic conditions that prevent the trial participation;
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.
Any neurological/orthopedic/cardiac condition (clinically evaluated)

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting

Santa Lucia Foundation I.R.C.C.S.
Roma, Rm, 00179
Marco Tramontano, 0651501420, m.tramontano@hsantalucia.it
Recruiting

Other trials in Italy

About this study

Official title: Dynamic Postural Stability Assessment in Neurorehabilitation

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.

Conditions: Stroke, Brain Injuries, Mild Cognitive Impairment, Parkinson Disease, Multiple Sclerosis
Medical subject headings: Stroke, Brain Injuries, Cognitive Dysfunction, Parkinson Disease, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04691102
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

Inertial sensors-based assessment
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)
Measured: Baseline

Secondary outcomes (4)

Berg Balance Scale (BBS)
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.
Measured: Baseline
Dynamic Gait Index (DGI)
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.
Measured: Baseline
Balance Evaluation System Test (Mini-BESTest)
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
Measured: Baseline
Electroencephalography (EEG)
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
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20211 Oct 2023

First posted31 Dec 2020
Study start1 May 2021
Primary completion30 Jun 2023 (estimated)
Study completion1 Oct 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 120 participants (estimated)
Target duration: 1 Day

IDs, dates and publications

ClinicalTrials.gov ID: NCT04691102
Sponsor's protocol ID: Prot. CE/PROG.877
Status last verified: Apr 2023
First submitted: 14 Oct 2020
Last updated: 18 Apr 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Recruiting
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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dynamic Postural Stability Assessment in Neurorehabilitation
ClinicalTrials.gov ID: NCT04691102
Acronym / sponsor ID: Prot. CE/PROG.877
Conditions: Stroke, Brain Injuries, Mild Cognitive Impairment, Parkinson Disease, Multiple Sclerosis
Study type: Observational
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
Study start: 1 May 2021 (actual)
Primary completion: 30 Jun 2023 (estimated)
Study completion: 1 Oct 2023 (estimated)
First posted: 31 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Prospective
Target follow-up: 1 Day
Number of arms: 6

Arm	Type	Receives
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.

Who may qualify

Ages: 15 to 85 years
Sex: All
Age groups: Child, Adult, Older adult
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

Key inclusion criteria (34 listed)

< 6 months from the acute event;
age range 18-85 years;
Functional Ambulation Category (FAC) ≥ 3.
Glasgow Coma Scale (GCS) ≤ 8;
Age range 15-65years;

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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)

4 secondary outcomes

Berg Balance Scale (BBS)
Time frame: Baseline
Dynamic Gait Index (DGI)
Time frame: Baseline
Balance Evaluation System Test (Mini-BESTest)
Time frame: Baseline
Electroencephalography (EEG)
Time frame: Baseline

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Recruiting
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Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

Roma, Italy

0651501420

m.tramontano@hsantalucia.it

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Brain Injuries, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inertial sensors-based assessment (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04691102.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.