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Clinical Trials/NCT04691102
NCT04691102
Recruiting
N/A

Dynamic Postural Stability Assessment in Neurorehabilitation

I.R.C.C.S. Fondazione Santa Lucia1 site in 1 country120 target enrollmentMay 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
I.R.C.C.S. Fondazione Santa Lucia
Enrollment
120
Locations
1
Primary Endpoint
Inertial sensors-based assessment
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
October 1, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
I.R.C.C.S. Fondazione Santa Lucia
Responsible Party
Principal Investigator
Principal Investigator

Marco Tramontano

Head of Rehabilitation Services

I.R.C.C.S. Fondazione Santa Lucia

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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

Study Sites (1)

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