Brain Injuries, Mild Cognitive Impairment, Multiple Sclerosis, Parkinson Disease, Stroke
Conditions
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.
Interventions
None listed
Sponsors
I.R.C.C.S. Fondazione Santa Lucia
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 85 Years
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inertial sensors-based assessment | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale (BBS) | 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. |
| Dynamic Gait Index (DGI) | 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. |
| Balance Evaluation System Test (Mini-BESTest) | 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 |
| Electroencephalography (EEG) | 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 |
Countries
Italy
Outcome results
None listed