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
Experimental: Dual Task exercise - combining motor and cognitive activities simultaneously
Control: Conventional Physical therapy
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].
| 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 |
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
Exclusion:
- Cognitive or motor comorbidities
- Severe visual or hearing impairments
- Aphasia
- Inability to walk independently
- 6-Minute Walking Test - measured at baseline, Day 56, and Day 146
- Montreal Cognitive Assessment (MoCA) - measured at baseline, Day 56, and 3-month follow-up
- Timed Up and Go (TUG) test
- Berg Balance Scale
- Fall frequency
- Quality of life measures (SF-36)
- Fatigue severity scale
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:
- Capacity Theory: Limited attentional resources must be divided between tasks
- Shared Resource Model: Motor and cognitive processes compete for neural substrates
- Automaticity Deficit: Neurological damage reduces automaticity of motor tasks
For Parkinson's 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
Rehabilitation strategies that address both motor and cognitive domains may provide superior outcomes compared to single-task training[@schott2018][@fritz2015].
- Attentional Training: Improves ability to divide and switch attention
- Motor-Cognitive Integration: Promotes automaticity of motor tasks
- Executive Function Enhancement: Challenges planning and monitoring
- Neuroplasticity: May induce cortical reorganization
Motor Domain:
- Improved gait speed and stability
- Reduced fall risk
- Enhanced balance
- Better functional mobility
Cognitive Domain:
- Improved executive function
- Better working memory
- Enhanced attention
- Reduced dual-task cost
Neural Mechanisms:
- Enhanced functional connectivity
- Increased gray matter volume
- More efficient neural activation
- Compensatory neural pathways[@marsiskova2018]
Parkinson's disease is characterized by:
- Bradykinesia and rigidity
- Gait dysfunction (shuffling, freezing)
- Cognitive impairment (executive dysfunction, attention deficits)
- High fall risk
Dual-task deficits in PD result from:
- Nigrostriatal dopamine depletion affecting automatic movement
- Frontal cortical dysfunction impairing executive control
- Limited capacity to automatomatically perform motor tasks[@dionelli2016]
Evidence for Dual-Task Training in PD:
- Improves gait parameters during dual-task conditions
- Reduces fall frequency
- Enhances quality of life
- Benefits maintained after training cessation[@li2020][@mclaughlin2010]
In multiple sclerosis, dual-task impairments arise from:
- Demyelination affecting neural conduction speed
- Cognitive fatigue limiting attentional resources
- Motor fatigue affecting physical performance
Dual-task training in MS:
- Improves gait stability during complex conditions
- May reduce fatigue severity
- Enhances functional independence
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
Evidence:
- Better transfer to real-world activities
- Improved community reintegration
- Reduced fear of falling
This trial uniquely includes Long COVID patients with neurological symptoms. Long COVID affects:
- Executive function and attention
- Processing speed
- Memory
- Gait and balance
Dual-task training may address these cognitive-motor deficits in post-COVID neurological sequelae.
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
Advantages over traditional approaches:
- Objective measurement of performance
- Tailored difficulty based on individual capacity
- Motivation through engaging interface
- Remote monitoring capabilities
Technology used:
- Inertial measurement units (IMUs)
- Pressure sensors
- Tablet-based cognitive tasks
- Mobile applications[@nordin2020]
¶ 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 |
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
Training Parameters:
- 3-5 sessions per week
- 30-45 minutes per session
- 4-8 week programs
- Progressive difficulty
Implementation:
- Requires trained therapists
- Technology investment
- Safety monitoring
- Individualized programming
Dual-task training is generally safe with minimal risks:
Potential Adverse Events:
- Mild fatigue
- Temporary balance disturbance
- Minor musculoskeletal discomfort
- Psychological frustration (manageable)
Contraindications:
- Severe cognitive impairment
- Uncontrolled medical conditions
- Acute illness
- Severe mobility limitations
This trial is relevant to several neurodegenerative disease areas:
- Motor and cognitive rehabilitation
- Fall prevention strategies
- Non-pharmacological interventions
- Functional recovery
- Fatigue management
- Gait and balance training
- Post-stroke rehabilitation
- Return to community mobility
- Cognitive-motor recovery
- Emerging neurological sequelae
- Cognitive rehabilitation
- Functional recovery
Positive outcomes from this trial could:
- Support broader adoption of dual-task training
- Guide development of technology-enhanced protocols
- Inform personalized training approaches
- Expand to other neurological conditions
Remaining questions include:
- Optimal training parameters (intensity, frequency, duration)
- Long-term maintenance of benefits
- Biomarkers for response prediction
- Combination with other interventions
- ClinicalTrials.gov: NCT07254377[@clinicaltrialsgov]
- Petzold A et al., Dual-task training in Parkinson's disease (2019)[@dualtask2019]
- Strouwen C et al., Training dual tasks together versus alone in Parkinson's disease (2017)[@strouwen2017]
- Melzer I et al., Balance and gait improvements in Parkinson's disease (2009)[@melzer2009]
- Schott N et al., Dual-task intervention for Parkinson's disease (2018)[@schott2018]
- Fritz NE et al., Cognitive-motor interference in Parkinson's disease (2015)[@fritz2015]
- Gaitán A et al., Dual-task gait in multiple sclerosis (2016)[@gaitan2016]
- Commodari E et al., Cognitive-motor dual task training in stroke rehabilitation (2020)[@commodari2020]
- Hemming L et al., Dual-task training effects on gait and balance in neurological conditions (2021)[@hemming2021]
- Cumming K et al., Dual-task cost and fall risk in neurological disease (2020)[@cumming2020]
- Bock O et al., Neural correlates of dual-task walking in Parkinson disease (2018)[@bock2018]
- Yogev G et al., Dual tasking affects gait in patients with Parkinson's disease (2005)[@yogev2005]
- Plummer P et al., Dual-task paradigm to assess motor and cognitive interaction (2018)[@plum2018]
- McLaughlin M et al., Task-oriented training for gait and balance in Parkinson's disease (2010)[@mclaughlin2010]
- Li X et al., Dual-task training improves executive function in Parkinson's disease (2020)[@li2020]
- Shumway-Cook A et al., Predicting falls in community-dwelling older adults (2018)[@shumway2018]
- Nordin E et al., Technology-enhanced dual-task training in neurorehabilitation (2020)[@nordin2020]
- Silsupadol P et al., Effects of balance training with dual-task (2009)[@silsupadol2009]
- Dionelli C et al., Dual-task costs are greater in Parkinson's disease with cognitive impairment (2016)[@dionelli2016]
- Marsiskova M et al., Neuroplasticity changes after dual-task training (2018)[@marsiskova2018]
- Morris R et al., Tai chi and dual-task training in Parkinson's disease (2019)[@morris2019]
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, multiple sclerosis, 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.
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
Dual-Task Training Advantages:
- More closely mirrors real-world demands
- Directly targets attention allocation deficits
- Promotes automaticity through dual engagement
- May induce greater neuroplastic changes
Motor Imagery:
- Mental rehearsal of movements without execution
- Activates similar neural networks to actual movement
- Can be combined with dual-task for enhanced training
Virtual Reality Training:
- Provides immersive, gamified rehabilitation
- Allows controlled challenge progression
- Can incorporate dual-task elements effectively
- Shows promise in Parkinson's disease rehabilitation
Exergaming:
- 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
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
Successful implementation could:
- Reduce burden on healthcare systems
- Decrease need for institutional care
- Improve patient independence
- Enhance quality of life for patients and caregivers
Regardless of outcomes, this trial will inform:
- Optimal parameters for dual-task training
- Patient characteristics predicting response
- Technology requirements for effective delivery
- Implementation strategies for clinical adoption
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
Based on current evidence, clinicians should consider:
- Assessing dual-task performance as part of standard evaluation
- Incorporating dual-task training in rehabilitation programs
- Progressively increasing task complexity
- Individualizing training based on patient capabilities
- Monitoring dual-task performance as outcome measure
¶ For Patients and Caregivers
Patients and families can:
- Ask about dual-task training options
- Practice dual-task activities at home
- Use technology to support practice
- Set realistic goals for improvement
- Maintain consistency with training programs
Future studies should address:
- Standardized outcome measures for dual-task training
- Optimal training dose and intensity
- Long-term maintenance of benefits
- Mechanisms of neuroplastic change
- Subgroup analyses for patient characteristics
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, multiple sclerosis, 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.