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

Condition(s) studied

Investigational drug(s) / intervention(s)

Dual Task exercise: Upper-limb sessions employ Virtual Art Therapy, during which the seated patient performs virtual painting tasks that simultaneously stimulate motor control and cognitive engagement. Balance training initially requires the patient to stand still with eyes closed-sometimes on unstable surfaces-while performing serial subtraction tasks, followed in later sessions by the Fukuda stepping test combined with the identification of male or female voices presented in congruent or incongruent sequences. Motor imagery sessions involve imagining the number of steps and time needed to reach a cone placed at varying distances before executing the actual movement. Gait training, conducted overground or on a treadmill, integrates various cognitive challenges: generating lists from semantic categories, recognizing objects or colors in the environment, repeating short word sequences for memory engagement, performing serial subtraction while walking, responding to directional auditory stimuli.

Physical therapy: Conventional exercises for upper and lower limbs motor rehabilitatiion

Study 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.

Eligibility

Primary outcome measure(s)

• 6-Minute Walking Test — Baseline (Day 1), end of treatment (Day 56), follow -up (146)
  The 6-Minute Walking Test is a standardized assessment of functional walking capacity in which the patient is instructed to walk back and forth along a predefined path for six minutes. The total distance covered during this time reflects the individual's aerobic endurance, mobility, and overall functional performance. The test is simple, well tolerated, and widely used in both clinical and research settings. The minimum score is about 300m and denotes a very low funcional motility, while higher distance covered (\> 600 m) is a sign of good walking ability.

Trial sites (1)

More I.R.C.C.S. Fondazione Santa Lucia trials in Italy

Other trials for the same condition