Clinical Research Directory

Design and Validation of Innovative Strategies Based on Dual-Task Approach

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

Summary

People affected by Stroke, Multiple Sclerosis (MS), and Parkinson's disease (PD) share severe and complex disabilities. Widespread neuro-inflammatory processes represent an important pathogenetic component in all three conditions. The potential overlap with neurological complications of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection has further contributed to the worsening of functional impairment. Since pharmacological therapies have limited or negligible effects in these disorders, neurorehabilitation plays a crucial role in restoring and maintaining adequate functional abilities. In this context, dual-task strategies have attracted growing interest, but their effectiveness has not been adequately assessed in the above neurological conditions-and not at all in individuals with long-term sequelae of SARS-CoV-2 infection. Based on these premises, the objectives of this research project are: * to design rehabilitation strategies using the dual-task approach in its various forms (dual motor task, dual cognitive task, and combined motor-cognitive task) and to conduct feasibility tests in small groups of individuals affected by stroke, MS, PD, or long-term Coronavirus Disease 2019 (COVID-19) sequelae; * to apply the strategies found to be effective in larger trials involving participants with stroke, MS, or PD, with or without a history of SARS-CoV-2 infection; * to compare the outcomes of dual-task strategies with those obtained through conventional rehabilitation approaches. The activities planned within the project will be distributed among the four participating operating units (OUs). OU1 (Santa Lucia Foundation) will be responsible for: 1. designing and validating dual-task rehabilitation strategies covering the three possible combinations of motor and cognitive activities (dual motor task, dual cognitive task, and combined motor-cognitive task); 2. assessing the feasibility of these strategies through a pilot study involving small groups of individuals with the aforementioned neurological conditions, including those with long-term outcomes of SARS-CoV-2 infection, and selecting the most suitable approaches. All four OUs will participate in the selection and enrollment of subjects for the trial phase. OUs 1, 3, and 4 (Collaborators to the project) will conduct the activities planned for the experimental trial, including: 1. baseline assessment of enrolled participants using validated instruments to measure various motor and cognitive functions; 2. implementation of rehabilitation strategies based on the dual-task approach, making use of newly emerging technological devices; 3. follow-up assessments at the end of the treatment period and again three months later. Assessments will focus on motor functions such as gait and balance, cognitive functions, mood, the occurrence of domestic accidents, and the measurement of circulating biomarkers of neuroinflammation and neurodegeneration. Data collected throughout the different phases of the study will be compiled into a single database, and statistical analyses will be performed by researchers from OU1. The interpretation of results will be carried out collaboratively by members of all OUs, and findings will be disseminated through participation in conferences and congresses, as well as through publications in peer-reviewed international indexed journals.

Official title: START: Design and Validation of Innovative Strategies Based on Dual-Task Approach for Neuro- Rehabilitation Technologically-supported in People With Chronic Neuro-inflammatory Disease

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