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

NCT07254377 | Active Not Recruiting

• 1 other identifier: PNRR-MCNT2-2023-12378271
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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:
• 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);
• 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.
• baseline assessment of enrolled participants using validated instruments to measure various motor and cognitive functions;
• implementation of rehabilitation strategies based on the dual-task approach, making use of newly emerging technological devices;
• follow-up assessments at the end of the treatment period and again three months later.

Conditions

Stroke; Multiple Sclerosis; Parkinson Disease; Dual Task Exercises; Long COVID

Keywords

dual task; cognitive motor integration; neurological disease; validation

Outcome Measures

Primary Outcomes (1)

• 6-Minute Walking Test

  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.

  Baseline (Day 1), end of treatment (Day 56), follow -up (146)

Secondary Outcomes (1)

• Montreal Cognitive Assessment

  Baseline (Day 1), End of Treatment (Day 56), 3-Month Follow-up (Day 146)

Study Arms (2)

Experimental Group (Dual Task training)

EXPERIMENTAL

The dual-task rehabilitation program includes a series of progressively complex activities targeting upper-limb function, balance, motor imagery, and gait.

Other: Dual Task exercise

Control Group (conventional motor exercises)

ACTIVE COMPARATOR

Patients in the control group will perform stationary cycling (or an equivalent low-resistance aerobic activity) instead of the dual-task training.

Other: Physical therapy

Interventions

Physical therapy OTHER

Conventional exercises for upper and lower limbs motor rehabilitatiion

Control Group (conventional motor exercises)

Dual Task exercise OTHER

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.

Experimental Group (Dual Task training)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of stroke outcomes, Multiple Sclerosis (MS), or Parkinson's disease (PD).
• For stroke outcomes: patients must be able to walk independently for at least 6 minutes without resting.
• For MS: diagnosis according to the 2017 revised McDonald criteria; relapsing-remitting or secondary progressive forms; age 25-65 years; Expanded Disability Status Scale score between 2.5 and 6.0.
• For PD: idiopathic Parkinson's disease.
• For each neurological condition, half of the participants must have had Severe Acute Respiratory Syndrome Coronavirus 2 infection with neurological symptoms attributable to CNS involvement lasting at least 4 weeks.
• Ability to provide informed consent.

You may not qualify if:

• Cognitive or motor comobidity;
• Severe visual or hearing impairments that may compromise understanding of exercises
• Language impairments, such as aphasia
• Inability to walk independently

Sponsors & Collaborators

• Vito Fazzi Hospital: collaborator
• ASL Frosinone: collaborator
• I.R.C.C.S. Fondazione Santa Lucia: lead
• Azienda Ospedaliera San Giovanni di Dio Ruggi d'Aragona: collaborator

Study Sites (1)

IRCCS Fondazione Santa Lucia

Roma, Roma, 00179, Italy

Location

MeSH Terms

Conditions

Stroke; Multiple Sclerosis; Parkinson Disease; Post-Acute COVID-19 Syndrome; Nervous System Diseases

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Marco Iosa, PhD, Associate Professor

  IRRCS Santa Lucia foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: November 1, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)