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Gait Pattern Analysis in Neurological Disease (NCT02994719)
Overview
Characterizing Gait Abnormalities in PSP and Parkinsonian Disorders
Trial Summary
...
Overview
Characterizing Gait Abnormalities in PSP and Parkinsonian Disorders
Trial Summary
| Field | Details |
|-------|---------|
| NCT Number | NCT02994719 |
| Title | Gait Pattern Analysis in Neurological Disease |
| Status | RECRUITING |
| Study Type | Observational (Case-Control) |
| Sponsor | Beth Israel Deaconess Medical Center |
| Principal Investigator | Veronique Vanderhorst, MD, PhD |
| Location | Boston, Massachusetts, USA |
Scientific Rationale
Gait dysfunction is a hallmark of Progressive Supranuclear Palsy (PSP), presenting distinct patterns that differentiate it from other parkinsonian disorders. Key gait characteristics in PSP include:
- Reduced gait velocity - significantly slower than age-matched controls
- Increased stride variability - reflecting impaired postural control
- Reduced arm swing - bilateral and often symmetric
- Forward flexion - truncal stooping during walking
- Retropulsion - tendency to fall backward
- Wide-based gait - increased stance phase width
This study aims to identify speed-dependent gait measures that can objectively quantify these abnormalities and potentially serve as biomarkers for disease progression and therapeutic response.[@clinicaltrialsgov]
Study Design
Primary Objectives
- Identify speed-dependent gait measures in parkinsonian disorders
- Determine whether gait patterns differ between:
- Parkinson's Disease (PD)
- Progressive Supranuclear Palsy (PSP)
- Multiple System Atrophy (MSA)
- Corticobasal Degeneration (CBD)
- Vascular Parkinsonism
- Other parkinsonian syndromes
- Compare patient gait patterns to age- and sex-matched healthy controls
Assessments
- Primary: Gait analysis using pressure sensors
- Optional interventions at second visit:
- Anti-Parkinson medication challenge (Carbidopa/levodopa, pramipexole, ropinirole, amantadine, tolcapone, entacapone)
- Deep Brain Stimulation evaluation
Eligibility Criteria
Inclusion Criteria
- Age 18-85 years
- Presence of at least 2 of the following (UK PD Brain Bank Criteria):
- Bradykinesia
- Rest tremor
- Rigidity
- Postural instability
- Subjects with assistive devices (canes, walkers) are eligible
- Healthy subjects with no complaints regarding difficulty walking
Exclusion Criteria
- Alternative explanation for parkinsonism (head trauma, drug-induced)
- Currently treated for major medical illness requiring recent hospitalization (<14 days)
- Currently participating in another clinical study with intervention arm
- Inability to consent due to cognitive impairment without legally authorized representative
- Cardiac/pulmonary conditions limiting ability to safely walk
Study Population
Includes subjects with:
- [Parkinson's Disease](/diseases/parkinsons-disease)
- Indeterminate parkinsonism
- Atypical Parkinsonisms:
- Vascular Parkinsonism
- Multiple System Atrophy (MSA)
- Progressive Supranuclear Palsy (PSP)
- Normal Pressure Hydrocephalus
- Corticobasal Degeneration (CBD)
- Ataxia syndromes
- Huntington Disease
- Healthy controls
Clinical Significance for PSP
Biomarker Potential
PSP-Specific Gait Features
- Reduced stride length with preserved cadence
- Bilateral reduced arm swing (early feature)
- Postural instability leading to backward falls
- Freezing of gait in advanced disease
- Response to levodopa typically minimal (distinguishes from PD)
Pathophysiology of Gait Disorders in PSP
Neuroanatomical Basis
Progressive supranuclear palsy (PSP) produces characteristic gait disturbances through degeneration of specific neural substrates:
Basal Ganglia Dysfunction: The globus pallidus interna (GPi) and substantia nigra pars reticulata (SNr) show early pathology in PSP, leading to:
- Impaired automatic motor sequencing
- Reduced stride length generation
- Axial rigidity affecting trunk mobility
- Bradykinesia of gait initiation
- Impaired postural adjustments
- Reduced automaticity of locomotion
- Freezing of gait phenomenon
- Gait ignition failure
- Executive motor control
- Velocity scaling of gait
- Adaptive responses to environmental demands
- Dual-task gait performance
Quantitative Gait Parameters
The study employs instrumented walkway analysis to capture:
| Parameter | PSP Characteristic | Clinical Significance |
|-----------|--------------------|-----------------------|
| Gait Velocity | Severely reduced (0.3-0.5 m/s) | Global motor impairment |
| Stride Length | Markedly shortened (<60 cm) | Basal ganglia dysfunction |
| Cadence | Preserved or slightly reduced | Differentiates from PD |
| Double Support Time | Increased (>35% stance) | Postural instability |
| Swing Time Variability | Elevated (CV >10%) | Fall risk predictor |
| Arm Swing | Severely reduced bilaterally | Early diagnostic marker |
| Trunk Rotation | Reduced | Axial rigidity |
Speed-Dependent Analysis
The novel aspect of this study examines how gait parameters change across walking speeds:
Healthy Controls: Linear increase in velocity through stride length modulation while cadence remains relatively stable
PSP Patients:
- Reduced stride length at all speeds
- Impaired velocity scaling
- Earlier onset of gait dysfunction at slower speeds
- Preserved speed-dependent modulation but at reduced magnitude
This approach may reveal:
- Subtle gait abnormalities not apparent at self-selected speed
- Differentiate disease subtypes
- Quantify reserve capacity in gait control systems
Differential Diagnosis Applications
PSP vs. Parkinson's Disease
| Feature | PSP | PD |
|---------|-----|-----|
| Arm swing | Bilateral reduction early | Unilateral, asymmetric early |
| Stride length | Severely reduced | Moderate reduction |
| Gait initiation | Often normal | Often impaired (shuffling) |
| Turning | En bloc turning | Shuffling turns |
| Postural falls | Early, backward | Late, any direction |
| Response to levodopa | Minimal | Good initially |
PSP vs. Multiple System Atrophy (MSA)
| Feature | PSP | MSA |
|---------|-----|-----|
| Gait pattern | Cautious, wide-based | Shuffling with festination |
| Stride variability | Increased | Very high |
| Freezing | Less common | More common |
| Autonomic involvement | Variable | Prominent early |
PSP vs. Corticobasal Degeneration (CBD)
| Feature | PSP | CBD |
|---------|-----|-----|
| Symmetry | Symmetric | Asymmetric |
| Arm swing | Bilaterally reduced | Unilaterally reduced |
| Gait initiation | Variable | Often延迟 |
Quantitative Gait Analysis Technology
Instrumented Walkway Systems
The study utilizes pressure-sensitive walkway technology:
Walkway Platforms:
- GAITrite® systems (standard in research)
- Zebris® FDM-T treadmill system
- Protokinetics® PKMAS
- Bertec® force instrumented treadmill
| Parameter | Specification | Clinical Relevance |
|-----------|--------------|------------------|
| Spatial resolution | 1.27 mm | Foot placement accuracy |
| Temporal resolution | 100-200 Hz | Timing accuracy |
| Active sensor area | Variable (4-8m length) | Full gait capture |
| Pressure range | Up to 200 psi | Weight-bearing accuracy |
| Data rate | Up to 500 Hz | Real-time capture |
Temporal-Spatial Parameters
Primary Measures:
- Stride time (time for complete gait cycle)
- Step time (time between foot strikes)
- Swing time (foot in air)
- Stance time (foot on ground)
- Single support time (contralateral foot in air)
- Double support time (both feet on ground)
- Stride length (distance covered per gait cycle)
- Step length (heel strike to opposite heel strike)
- Step width (mediolateral foot placement)
- Foot rotation angle
- Toe-out angle
- Gait velocity (comfortable walking speed)
- Cadence (steps per minute)
- Variability measures (coefficient of variation)
Advanced Analysis Methods
Center of Pressure (COP):
- Anterior-posterior COP excursion
- Medial-lateral COP excursion
- COP velocities
- COP trajectory symmetry
- Sway area
- Velocity of sway
- Frequency distribution
- Multi-scale entropy
Neuroanatomical Correlates
Basal Ganglia Contributions
The basal ganglia play a central role in gait control:
Direct Pathway (Go):
- Facilitates voluntary movements
- Promotes ongoing motor programs
- Facilitates gait initiation
- Reduced in PSP leading to akinesia
- Inhibits competing movements
- Prevents unwanted movement
- Critical for stopping/gait adjustment
- Overactive in PSP
- Rapid feedback inhibition
- Error detection
- Adaptive modifications
Brainstem Gait Centers
Pedunculopontine Nucleus (PPN):
- Central pattern generator for locomotion
- Cholinergic neurons for modulation
- Associated with gait freezing
- Sensory integration
- Proprioceptive processing
- Postural adjustments
Cerebellar Contributions
The cerebellum coordinates gait:
Spinocerebellar Pathways:
- Proprioceptive feedback
- Motor adaptation
- Error correction
- Motor learning
- Automation of gait
Frontal Lobe Networks
Supplementary Motor Area (SMA):
- Internal movement generation
- Bilateral coordination
- Impaired in PSP
- Sequence planning
- Gait initiation
- Abnormal in PSP
- Executive function
- Dual-task performance
- Planning gait modifications
Biomarker Development
Gait as a Biomarker
Gait parameters can serve as biomarkers:
Validation Requirements:
- Reliability (test-retest consistency)
- Validity (measures what it claims)
- Sensitivity to change
- Specificity for condition
- Responsiveness to intervention
Clinical Applications
Diagnostic Aid:
- Differentiating parkinsonian disorders
- Early detection
- Subtype classification
- Disease severity staging
- Progression rate
- Prognostication
- Medication effects
- Surgical outcomes (DBS)
- Rehabilitation benefits
Regulatory Status
- Not FDA-approved biomarkers
- Research use only
- Potential for clinical implementation
Future Directions
Technology Development
Wearable Sensors:
- Inertial measurement units
- Accelerometers
- Gyroscopes
- Magnetometers
- Continuous monitoring
- Fall detection
- Activity tracking
- Pattern recognition
- Subtype classification
- Predictive modeling
Research Applications
- Earlier diagnosis
- Personalized intervention
- Telehealth integration
Assessment Protocols
Instrumented Gait Analysis System
The study utilizes pressure-sensitive walkway technology:
Testing Protocol
Conditions Tested:
Repeatability Measures: Three trials per condition to establish reliability
Clinical Correlation Assessments
- MDS-UPDRS: Complete motor examination
- PSPRS: PSP Rating Scale
- MoCA: Cognitive screening
- FR: Functional reach test
- TUG: Timed up and go test
Medication Challenge Protocol
Rationale
The medication challenge component evaluates dopaminergic responsiveness:
Levodopa Challenge: Standard carbidopa/levodopa (25/100 mg) up to 200% of current dose
Dopamine Agonists: Pramipexole or ropinirole equivalent
Rationale:
- Differentiate parkinsonian disorders
- Identify PD patients who may benefit from DBS
- Quantify levodopa-responsive component
- Predict surgical outcomes
Assessment Timing
- Baseline gait assessment
- 60-90 minutes post-medication
- Peak-dose assessment
- Comparison of pre/post parameters
Implications for Clinical Care
Biomarker Development
Quantitative gait analysis offers advantages as a biomarker:
Clinical Utility
This study may establish gait parameters for:
- Early diagnosis (pre-motor detection)
- Disease staging and progression monitoring
- Therapeutic response assessment
- Fall risk stratification
- Prognostication
Future Applications
Successful validation could lead to:
- Routine clinical gait assessment for movement disorder patients
- Telemedicine-enabled remote monitoring
- Home-based gait monitoring with wearable sensors
- Integration with digital health platforms
Comparative Gait Research
Key Studies in PSP Gait
Historical Context:
| Study | Year | Key Finding |
|-------|------|------------|
|(non) | 1990s | First quantitative gait studies in PSP |
| Thompson et al. | 2007 | Reduced gait velocity in PSP vs. PD |
| Baba et al. | 2012 | Turning characteristics distinguish PSP |
| Latt et al. | 2009 | Stride variability predicts falls |
| Chien et al. | 2013 | Longitudinal gait changes |
Current Understanding:
- PSP gait characteristics are distinct from PD
- Quantitative measures can aid diagnosis
- Progression can be tracked longitudinally
- Falls correlate with specific parameters
Methodological Considerations
Test-Retest Reliability:
- Moderate-to-high reliability for most parameters
- Best reliability for gait velocity and stride length
- Moderate reliability for variability measures
- Requires standardized protocols
- Not well-established for most parameters
- Estimated at 10-15% change
- Depends on baseline function
Technology Considerations
Equipment Requirements
Laboratory Setup:
- Pressure-sensitive walkway
- Video recording system
- Safety equipment (harness, assist)
- Climate control
- Dedicated software packages
- Quality control procedures
- Standardized analysis protocols
- Trained technicians
- Physical therapist supervision
- Data analyst
Cost Considerations
Initial Investment:
- Walkway systems: $15,000-50,000
- Video equipment: $2,000-10,000
- Software licenses: $1,000-5,000
- Consumables: minimal
- Maintenance: $1,000-3,000/year
- Personnel: one FTE per lab
Quality Assurance
Data Quality Measures
Collection Standards:
- Regular calibration
- Standardized instructions
- Multiple trials
- Quality review protocols
- Automated quality checks
- Manual over-read protocols
- Inter-rater reliability
Standardization Efforts
International Efforts:
- Movement Disorder Society consensus
- Genie in the Gait collaboration
- Standardization committees
Research Contributions
Advancing Understanding
This study contributes to:
Collaborative Potential
Data sharing may enable:
- Multi-center validation studies
- Machine learning for pattern recognition
- Subtype classification algorithms
- Predictive modeling for individualized prognosis
Clinical Implementation
Practical Considerations
Clinical Integration:
- Time requirements (30-45 minutes)
- Space requirements (10-meter walkway)
- Staff training (4-8 hours)
- Quality control procedures
- Limited insurance coverage
- Research/clinical trial use
- Fee-for-service in some settings
Barriers to Implementation
Practical Barriers:
- Equipment cost
- Space requirements
- Staff expertise
- Time constraints
- Interpretation expertise
- Reference data availability
- Clinical guidelines
Emerging Technologies
Wearable Sensors
Inertial Measurement Units (IMUs):
- Accelerometers
- Gyroscopes
- Magnetometers
- Barometric altimeters
- Continuous monitoring
- Home-based assessment
- Fall detection
- Activity tracking
- Multiple studies published
- Moderate agreement with instrumented walkways
- Emerging clinical use
Smartphone Applications
Available Applications:
- Step counter apps
- Gait analysis apps
- Balance assessment apps
- Fall detection apps
- Variable accuracy
- Not validated for clinical use
- Research applications only
Artificial Intelligence
Machine Learning Applications:
- Feature extraction
- Pattern recognition
- Classification algorithms
- Predictive modeling
- Differential diagnosis
- Prognostication
- Treatment response prediction
- Need for large datasets
- Validation requirements
- Interpretability challenges
References
Cross-Links
- [Progressive Supranuclear Palsy](/diseases/progressive-supranuclear-palsy)
- [Gait and Balance Disorders in PSP - Comprehensive gait analysis](/diseases/progressive-supranuclear-palsy)
- [PSP Clinical Trials Guide - Comprehensive trial listing](/diseases/progressive-supranuclear-palsy)
- [Exercise and Physical Activity for CBS/PSP - Therapeutic interventions](/diseases/progressive-supranuclear-palsy)
- [Fall Prevention in PSP - Prevention strategies](/diseases/progressive-supranuclear-palsy)
- [Parkinson's Disease Gait](/mechanisms/parkinsonian-gait)
- [Basal Ganglia and Motor Control](/mechanisms/basal-ganglia-motor-control)
- [Brainstem Gait Control Centers](/mechanisms/brainstem-locomotor-regions)
External Links
- [ClinicalTrials.gov - NCT02994719](https://clinicaltrials.gov/study/NCT02994719)
- [Beth Israel Deaconess Medical Center](https://www.bidmc.org/)
- [PubMed - Gait in PSP](https://pubmed.ncbi.nlm.nih.gov/31234567/)
- [KEGG Pathways](https://www.genome.jp/kegg/pathway.html)
Additional References
Location & Contact
Site: Beth Israel Deaconess Medical Center Address: Clinical Research Center, Boston, Massachusetts 02215, USA Principal Investigator: Veronique Vanderhorst, MD, PhD Phone: 617-667-0519 Email: vvanderh@bidmc.harvard.edu
Cross-Links
- [Progressive Supranuclear Palsy](/diseases/progressive-supranuclear-palsy)
- [Gait and Balance Disorders in PSP - Comprehensive gait analysis](/diseases/progressive-supranuclear-palsy)
- [PSP Clinical Trials Guide - Comprehensive trial listing](/diseases/progressive-supranuclear-palsy)
- [Exercise and Physical Activity for CBS/PSP - Therapeutic interventions](/diseases/progressive-supranuclear-palsy)
- [Fall Prevention in PSP - Prevention strategies](/diseases/progressive-supranuclear-palsy)
- [Parkinson's Disease Gait](/mechanisms/parkinsonian-gait)
- [Basal Ganglia and Motor Control](/mechanisms/basal-ganglia-motor-control)
- [Brainstem Gait Control Centers](/mechanisms/brainstem-locomotor-regions)
- [Alzheimer's Disease](/diseases/alzheimers-disease)
- [Parkinson's Disease](/diseases/parkinsons-disease)
- [Multiple System Atrophy](/diseases/multiple-system-atrophy)
- [Corticobasal Degeneration](/diseases/corticobasal-degeneration)
External Links
- [ClinicalTrials.gov - NCT02994719](https://clinicaltrials.gov/study/NCT02994719)
- [Beth Israel Deaconess Medical Center](https://www.bidmc.org/)
- [PubMed - Gait in PSP](https://pubmed.ncbi.nlm.nih.gov/31234567/)
- [KEGG Pathways](https://www.genome.jp/kegg/pathway.html)
Data Quality Metrics
Quality checks implemented:
| Metric | Threshold | Action |
|--------|-----------|--------|
| Foot contacts | >95% | Review |
| Valid trials | ≥3 per condition | Repeat |
| Sensor calibration | Within specs | Recalibrate |
| Data completeness | >98% | Query |
Clinical Implementation
Practical Considerations
Translating research to clinical practice:
Barriers to Implementation
Common challenges faced:
- Reimbursement: Limited coding options
- Staff time: Competitive w/ other evaluations
- Space: Clinical setting limitations
- Patient tolerance: Fatigue during assessment
Solutions and Workarounds
Addressing implementation barriers:
Emerging Technologies
Wearable Devices
Emerging technologies include:
| Device | Parameters | Advantages |
|--------|------------|-------------|
| Inertial sensors | Accelerometry, gyroscopy | Portable |
| Pressure insoles | Plantar pressure | Direct measurement |
| Optoelectronic | 3D motion capture | High precision |
| RGB-D cameras | Computer vision | Markerless |
Artificial Intelligence
AI applications in gait analysis:
Research Advocacy
Patient and Family Engagement
Key stakeholders in research:
Collaborative Networks
Building research infrastructure:
References
Location & Contact
Site: Beth Israel Deaconess Medical Center Address: Clinical Research Center, Boston, Massachusetts 02215, USA Principal Investigator: Veronique Vanderhorst, MD, PhD Phone: 617-667-0519 Email: vvanderh@bidmc.harvard.edu
- [Gait and Balance Disorders in PSP - Comprehensive gait analysis](/diseases/progressive-supranuclear-palsy)
- [PSP Clinical Trials Guide - Comprehensive trial listing](/diseases/progressive-supranuclear-palsy)
- [Exercise and Physical Activity for CBS/PSP - Therapeutic interventions](/diseases/progressive-supranuclear-palsy)
- [Fall Prevention in PSP - Prevention strategies](/diseases/progressive-supranuclear-palsy)
- [Alzheimer's Disease](/diseases/alzheimers-disease)
- [Parkinson's Disease](/genes/ar)
External Links
- [PubMed](https://pubmed.ncbi.nlm.nih.gov/)
- [KEGG Pathways](https://www.genome.jp/kegg/pathway.html)
References
See Also
Related Analyses:
- [4R-tau strain-specific spreading patterns in PSP vs CBD](/analysis/SDA-2026-04-01-gap-005)
- [sda-2026-04-01-001](/analysis/sda-2026-04-01-001)
- [sda-2026-04-01-002](/analysis/sda-2026-04-01-002)
- [ER-Golgi Secretory Pathway Dysfunction in PD - Experiment Design](/experiment/exp-wiki-experiments-er-golgi-secretory-pathway-parkinsons)
- [Cytochrome Therapeutics](/experiment/exp-wiki-experiments-lipid-droplet-lysosome-axis-parkinsons)
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