nct07254377-start

START: Dual-Task Approach for Neuro-Rehabilitation (NCT07254377)

Overview

Clinical Trial ID: NCT07254377

START: Dual-Task Approach for Neuro-Rehabilitation (NCT07254377)

Overview

Clinical Trial ID: NCT07254377

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

Status: Active, not recruiting

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

Start Date: November 1, 2025

Estimated Completion: February 28, 2027

Conditions Studied

• [Stroke](/diseases/stroke)](/diseases/stroke)
• [Multiple Sclerosis](/diseases/multiple-sclerosis)
• [Parkinson Disease](/diseases/parkinsons-disease)
• Long COVID (post-acute sequelae of SARS-CoV-2)

Intervention

Experimental: Dual Task exercise - combining motor and cognitive activities simultaneously

Control: Conventional Physical therapy

Study Design

This clinical trial tests innovative dual-task rehabilitation strategies that combine motor and cognitive training simultaneously. The study aims to compare dual-task approaches with conventional rehabilitation methods in patients with chronic neuro-inflammatory conditions[@clinicaltrialsgov].

Trial Parameters

| Parameter | Value |
|-----------|-------|
| Phase | Not Applicable (Device/Behavioral) |
| Allocation | Randomized |
| Intervention Model | Parallel |
| Masking | Single-blind (outcomes assessor) |
| Primary Purpose | Treatment |
| Estimated Enrollment | 120 participants |
| Duration | 6 months per participant |

Eligibility Criteria

Inclusion:

• Diagnosis of stroke, multiple sclerosis, or Parkinson's disease
• Age 18-80 years
• Ability to walk independently (stroke patients: at least 6 minutes walking distance)
• For MS patients: EDSS score 2.5-6.0, age 25-65
• At least 50% of participants must have history of SARS-CoV-2 infection with neurological symptoms lasting ≥4 weeks

• Cognitive or motor comorbidities
• Severe visual or hearing impairments
• Aphasia
• Inability to walk independently

Outcomes

Primary Outcome

• 6-Minute Walking Test - measured at baseline, Day 56, and Day 146

Secondary Outcome

• Montreal Cognitive Assessment (MoCA) - measured at baseline, Day 56, and 3-month follow-up

Additional Outcomes

• Timed Up and Go (TUG) test
• Berg Balance Scale
• Fall frequency
• Quality of life measures (SF-36)
• Fatigue severity scale

Scientific Rationale

Dual-Task Paradigm in Neurological Conditions

Dual-task training involves performing two tasks simultaneously, which challenges the brain's ability to allocate attention resources between motor and cognitive functions. This approach is particularly relevant for neurodegenerative conditions where patients often experience both motor and cognitive impairments[@dualtask2019][@stroumen2017].

Theoretical Foundation:

Why Dual-Task Training?

For [Parkinson's disease](/diseases/parkinsons-disease), dual-task interference is a well-documented phenomenon[@yogev2005][@bock2018]:

• Gait automatically deteriorates during cognitive tasks
• Falls often occur during divided attention activities
• Traditional rehabilitation focuses on single tasks, missing real-world demands

Mechanism of Action

How Dual-Task Training Works

Expected Benefits

Motor Domain:

• Improved gait speed and stability
• Reduced fall risk
• Enhanced balance
• Better functional mobility

• Improved executive function
• Better working memory
• Enhanced attention
• Reduced dual-task cost

• Enhanced functional connectivity
• Increased gray matter volume
• More efficient neural activation
• Compensatory neural pathways[@marsiskova2018]

Application to Specific Conditions

Parkinson's Disease

[Parkinson's disease](/diseases/parkinsons-disease) is characterized by:

• Bradykinesia and rigidity
• Gait dysfunction (shuffling, freezing)
• Cognitive impairment (executive dysfunction, attention deficits)
• High fall risk

• Nigrostriatal dopamine depletion affecting automatic movement
• Frontal cortical dysfunction impairing executive control
• Limited capacity to automatomatically perform motor tasks[@dionelli2016]

• Improves gait parameters during dual-task conditions
• Reduces fall frequency
• Enhances quality of life
• Benefits maintained after training cessation[@li2020][@mclaughlin2010]

Multiple Sclerosis

In multiple sclerosis, dual-task impairments arise from:

• Demyelination affecting neural conduction speed
• Cognitive fatigue limiting attentional resources
• Motor fatigue affecting physical performance

• Improves gait stability during complex conditions
• May reduce fatigue severity
• Enhances functional independence

Stroke

Post-stroke rehabilitation benefits from dual-task training through:

• Retraining of motor-cognitive integration
• Improving attention to safety during mobility
• Enhancing recovery of executive function

• Better transfer to real-world activities
• Improved community reintegration
• Reduced fear of falling

Long COVID

This trial uniquely includes Long COVID patients with neurological symptoms. Long COVID affects:

• Executive function and attention
• Processing speed
• Memory
• Gait and balance

Technology Platform

Technologically-Supported Rehabilitation

The START trial employs technology-enhanced dual-task training:

Components:

• Sensor-based motion tracking
• Cognitive challenge calibration
• Real-time performance feedback
• Personalized difficulty progression
• Gamified training elements

• Objective measurement of performance
• Tailored difficulty based on individual capacity
• Motivation through engaging interface
• Remote monitoring capabilities

• Inertial measurement units (IMUs)
• Pressure sensors
• Tablet-based cognitive tasks
• Mobile applications[@nordin2020]

Clinical Implications

Comparison with Standard Rehabilitation

| Approach | Single-Task Training | Dual-Task Training |
|----------|---------------------|-------------------|
| Focus | Isolated motor or cognitive | Integrated motor-cognitive |
| Real-world applicability | Limited | High |
| Attentional demands | Single | Divided |
| Learning transfer | Variable | Good |
| Complexity | Lower | Higher |

Who Benefits Most?

Dual-task training may be particularly beneficial for:

• Patients with cognitive impairment
• Those with high fall risk
• Individuals with motor-cognitive deficits
• Patients seeking return to complex activities

Practical Considerations

Training Parameters:

• 3-5 sessions per week
• 30-45 minutes per session
• 4-8 week programs
• Progressive difficulty

• Requires trained therapists
• Technology investment
• Safety monitoring
• Individualized programming

Safety Profile

Dual-task training is generally safe with minimal risks:

Potential Adverse Events:

• Mild fatigue
• Temporary balance disturbance
• Minor musculoskeletal discomfort
• Psychological frustration (manageable)

• Severe cognitive impairment
• Uncontrolled medical conditions
• Acute illness
• Severe mobility limitations

Relevance to NeuroWiki

This trial is relevant to several neurodegenerative disease areas:

For [Parkinson's Disease](/diseases/parkinsons-disease)

• Motor and cognitive rehabilitation
• Fall prevention strategies
• Non-pharmacological interventions

For [Multiple Sclerosis](/diseases/multiple-sclerosis)

• Functional recovery
• Fatigue management
• Gait and balance training

For [Stroke](/diseases/stroke)

• Post-stroke rehabilitation
• Return to community mobility
• Cognitive-motor recovery

For Long COVID

• Emerging neurological sequelae
• Cognitive rehabilitation
• Functional recovery

Future Directions

If Positive Results

Positive outcomes from this trial could:

Research Gaps

Remaining questions include:

• Optimal training parameters (intensity, frequency, duration)
• Long-term maintenance of benefits
• Biomarkers for response prediction
• Combination with other interventions

See Also

• [Parkinson's Disease](/diseases/parkinsons-disease)](/proteins/parkin)
• [Multiple Sclerosis](/diseases/multiple-sclerosis)
• [Stroke](/diseases/stroke)](/diseases/stroke)
• [Long COVID](/diseases/long-covid)
• [Neurorehabilitation](/therapeutics/neurorehabilitation-therapies)](/therapeutics)
• [Cognitive Rehabilitation](/therapeutics/cognitive-rehabilitation-therapies)](/therapeutics)
• [Balance Training](/therapeutics/balance-training-therapies)

External Links

• [NCT07254377 on ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT07254377)
• [I.R.C.C.S. Fondazione Santa Lucia](https://www.fondazionesantalucia.it/)
• [European Parkinson's Disease Association](https://www.epda.eu.com/)](/proteins/parkin)
• [Multiple Sclerosis Federation](https://msif.org/)

References

Conclusion

This trial represents an important step in validating technologically-supported dual-task training for neurological conditions. By examining four distinct patient populations - [Parkinson's disease](/diseases/parkinsons-disease), [multiple sclerosis](/diseases/multiple-sclerosis), [stroke](/diseases/stroke), and Long COVID - the START trial may establish a novel rehabilitation paradigm applicable across multiple neurological disorders.

The integration of technology with dual-task training offers several advantages over traditional approaches: objective measurement of performance, personalized difficulty progression, and enhanced patient engagement. If successful, this approach could significantly improve functional outcomes for patients with motor and cognitive deficits.

Comparison to Other Neurorehabilitation Approaches

Single-Task vs. Dual-Task Training

Traditional rehabilitation has focused on single-task training, where patients practice one skill at a time. While effective for basic function recovery, this approach often fails to translate to real-world situations where patients must divide attention between multiple demands.

Single-Task Training Limitations:

• Does not address divided attention deficits
• Limited transfer to complex daily activities
• May not challenge executive function adequately
• May not engage neural networks for dual-task performance

• More closely mirrors real-world demands
• Directly targets attention allocation deficits
• Promotes automaticity through dual engagement
• May induce greater neuroplastic changes

Other Similar Approaches

Motor Imagery:

• Mental rehearsal of movements without execution
• Activates similar neural networks to actual movement
• Can be combined with dual-task for enhanced training

• Provides immersive, gamified rehabilitation
• Allows controlled challenge progression
• Can incorporate dual-task elements effectively
• Shows promise in Parkinson's disease rehabilitation

• Combines exercise with game elements
• Often inherently involves dual-task demands
• Highly motivating for patient engagement
• Good adherence to training protocols

Economic and Healthcare Considerations

Cost-Effectiveness

Dual-task training using technology may offer cost advantages:

• Reduced therapist time per session with technology assistance
• Potential for home-based training
• Reduced healthcare utilization through fall prevention
• Earlier return to work and productivity

Healthcare System Impact

Successful implementation could:

• Reduce burden on healthcare systems
• Decrease need for institutional care
• Improve patient independence
• Enhance quality of life for patients and caregivers

Future Research Directions

Beyond This Trial

Regardless of outcomes, this trial will inform:

Emerging Areas

Future research may explore:

• Virtual reality-enhanced dual-task training
• Wearable sensors for continuous monitoring
• Home-based telerehabilitation programs
• Personalized dual-task protocols based on genetic or biomarker profiles
• Combination with non-invasive brain stimulation
• Integration with pharmacological interventions

Practical Recommendations

For Clinicians

Based on current evidence, clinicians should consider:

For Patients and Caregivers

Patients and families can:

For Researchers

Future studies should address:

Summary

The START trial (NCT07254377) represents an innovative approach to neurorehabilitation that addresses the critical issue of dual-task deficits in neurological conditions. By combining technology with evidence-based dual-task training principles, this trial may establish a new paradigm for rehabilitation in [Parkinson's disease](/diseases/parkinsons-disease), [multiple sclerosis](/diseases/multiple-sclerosis), [stroke](/diseases/stroke), and Long COVID.

The comprehensive nature of this trial - examining both motor and cognitive outcomes across multiple conditions - positions it to make significant contributions to the field of neurorehabilitation. Positive results could change clinical practice and improve outcomes for millions of patients with neurological conditions worldwide.