DANU Sports System for Gait/Balance Assessment in Parkinson's Disease (NCT07281794)

DANU Sports System for Gait and Balance Assessment in Parkinson's Disease (NCT07281794)

Overview

DANU Sports System for Gait and Balance Assessment in Parkinson's Disease (NCT07281794)

Overview

This observational study (NCT07281794), conducted by [Northumbria University](https://www.northumbria.ac.uk/) in partnership with [DANU Sports Ltd](https://www.danusports.com/), evaluates the clinical validity of the DANU Sports System as a tool for assessing gait and balance in patients with [Parkinson's Disease](/diseases/parkinsons-disease). The study compares sensor-derived measurements from the DANU system against standard clinical assessments to determine whether it can serve as a reliable, objective alternative for quantifying Parkinsonian gait dysfunction["@nct"].

Trial Details

| Parameter | Value |
|-----------|-------|
| NCT Number | NCT07281794 |
| Title | Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease |
| Status | Recruiting |
| Study Type | Observational |
| Enrollment | 60 participants (30 PD + 30 Healthy Controls) |
| Sponsor | Northumbria University |
| Collaborator | DANU Sports Ltd |
| Start Date | August 8, 2025 |
| Estimated Completion | September 2027 |
| Location | Northumbria University, Newcastle upon Tyne, United Kingdom |

Scientific Rationale

The Need for Objective Gait Assessment in PD

Clinical gait assessment in Parkinson's disease relies heavily on subjective rating scales and observer-dependent measurements. The [MDS-UPDRS](/diseases/parkinsons-disease) Part III provides standardized motor evaluation, but its temporal resolution is limited — capturing function at a single time point rather than during naturalistic movement. Quantitative gait analysis laboratory equipment is expensive, stationary, and often inaccessible to clinicians and researchers outside specialized centers[@nct].

DANU Sports System

The DANU Sports System is a wearable sensor-based platform designed to capture quantitative gait and balance metrics during everyday movement. By using inertial measurement units (IMUs) and proprietary analytics, it aims to provide:

Clinical Validation Pathway

Before a measurement tool can be adopted clinically, its outputs must be validated against established reference standards. This study establishes that validation by:

• Recruiting matched cohorts of PD patients and healthy controls
• Administering both the DANU system and standard clinical assessments in a single visit
• Comparing sensor-derived metrics against validated clinical measures
• Establishing sensitivity (ability to detect PD-related impairment) and specificity (ability to distinguish from healthy aging)

Study Design

Observational Cross-Sectional Study

The study uses a cross-sectional, case-control design with two groups:

| Group | N | Description |
|-------|---|-------------|
| Parkinson's Group | 30 | Clinically diagnosed PD, Hoehn & Yahr stages I–III |
| Healthy Control Group | 30 | Age-matched individuals without neurological disease |

Single-Visit Protocol

All outcome measures are obtained during a single study visit (Day 1), minimizing confounds from day-to-day variability in motor function. Both groups undergo identical assessment protocols, enabling direct comparison of gait metrics between PD patients and age-matched controls.

Outcome Measures

The study captures a comprehensive set of spatiotemporal gait parameters as primary outcomes[@nct]:

Spatiotemporal Parameters

| Parameter | Description | Clinical Relevance |
|-----------|-------------|-------------------|
| Stride Length | Distance between successive heel strikes of the same foot | Reduced in PD; correlates with disease severity |
| Step Time | Time between heel strikes of opposite feet | Prolonged in PD; contributes to slow gait |
| Stride Time | Time between successive heel strikes of the same foot | Indicates gait rhythm disturbances |
| Cadence | Steps per minute | Reduced in PD; reflects bradykinesia |
| Ground Contact Time | Duration of foot contact with ground | Increased in PD; indicates shuffling gait |
| Swing Time | Duration of foot airborne phase | Decreased in PD; reflects reduced foot clearance |
| Stride Velocity | Stride length divided by stride time | Reduced in PD; overall slower gait |
| Gait Velocity | Center of mass progression speed | Strong predictor of fall risk and functional status |

Centre of Pressure / Sway Parameters

| Parameter | Description | Clinical Relevance |
|-----------|-------------|-------------------|
| Area of Ellipse | 95% confidence ellipse of COP sway | Reflects overall postural stability |
| Length of Ellipse | Major axis of sway ellipse | Indicates anterior-posterior instability |
| Width of Ellipse | Minor axis of sway ellipse | Indicates medio-lateral instability |
| Total Displacement | Cumulative COP movement | Elevated in PD; indicates compensatory adjustments |
| Medio-Lateral Range | Maximum side-to-side COP excursion | Sensitive to balance impairment |
| Anterior-Posterior Range | Maximum forward-backward COP excursion | Indicates postural control deficits |

Eligibility Criteria

Parkinson's Disease Group

Inclusion Criteria

• Clinical diagnosis of [Parkinson's Disease](/diseases/parkinsons-disease) by a movement disorder specialist according to [UK Brain Bank criteria](https://pubmed.ncbi.nlm.nih.gov/12483750/)[@ukbb]
• Hoehn & Yahr Rating Scale stages I–III
• Ability to attend [Northumbria University](https://www.northumbria.ac.uk/) for study visits
• Ability to walk and stand unassisted for a minimum of 2 minutes
• Aged 50 years or older

Exclusion Criteria

• History of neurological disorders other than PD (e.g., Huntington's disease, stroke, traumatic brain injury, multiple sclerosis, Alzheimer's disease)
• Inability to walk or stand unaided
• [Montreal Cognitive Assessment (MoCA)](https://www.mocatest.org/) score < 21[@mocha]
• Significant issues unrelated to PD that may affect gait (e.g., musculoskeletal issues, back pain, recent surgery)

Healthy Control Group

Controls are age-matched to the PD group and screened for absence of neurological conditions and significant musculoskeletal impairments affecting gait.

Rationale for Age and Cognitive Thresholds

• Age ≥50: Ensures a representative PD population (median age at diagnosis is ~65 years) while excluding younger-onset cases that may have distinct genetic etiologies
• MoCA ≥21: Excludes moderate cognitive impairment, which could affect ability to follow assessment protocols and confound gait measurements through attentional confounds

Connection to Parkinson's Disease Pathology

Dopaminergic Contributions to Gait

Gait dysfunction in Parkinson's disease stems from [dopaminergic neuron loss](/cell-types/dopaminergic-neurons-snpc) in the [substantia nigra pars compacta](/brain-regions/substantia-nigra). The nigrostriatal pathway is critical for:

Loss of [dopamine](/proteins/dopamine) disrupts these functions, producing the characteristic PD gait triad:

• Shuffling gait (reduced stride length, increased ground contact time)
• Bradykinesia (slowed gait velocity, reduced cadence)
• Freezing episodes (sudden motor blocks, particularly during turns or narrow spaces)

Alpha-Synuclein and Gait Control

Beyond dopaminergic cell loss, [alpha-synuclein](/proteins/alpha-synuclein) pathology in non-dopaminergic systems contributes to gait dysfunction:

• Pedunculopontine nucleus (PPN) — Brainstem nucleus critical for locomotor control; degenerates in PD
• Cholinergic forebrain nuclei — Noradrenergic locus coeruleus and cholinergic basal forebrain contribute to attention-dependent gait control
• Spinal cord circuits — Alpha-synuclein aggregates found in spinal cord neurons

Postural Stability and Balance

The center of pressure (COP) sway parameters measured in this study reflect the integrity of postural control systems:

Elevated sway area and displacement indicate that PD patients employ greater muscular effort to maintain standing balance — a compensatory strategy that increases fatigue and fall risk.

Clinical Significance

Biomarker Development

Quantitative gait metrics have emerged as potential biomarkers for PD progression and treatment response. This study contributes to that pipeline by:

Comparison with Other Gait Assessment Tools

| Tool | Method | Strengths | Limitations |
|------|--------|-----------|-------------|
| DANU Sports System (NCT07281794) | Wearable IMU sensors | Portable, continuous, objective | Validation ongoing |
| Instrumented Walkway (GAITRite) | Pressure-sensitive mat | Gold standard spatial parameters | Stationary, single trial |
| OptiTrack Motion Capture | Optical tracking | High precision, 3D kinematics | Expensive, laboratory-based |
| MDS-UPDRS III Item 29 | Clinical rating | Standardized, validated | Subjective, low resolution |
| Timed Up and Go (TUG) | Stopwatch timing | Simple, widely used | Limited parameter set |

Fall Risk Prediction

Gait velocity and stride length are among the strongest predictors of falls in Parkinson's disease. A validated wearable system could enable:

• At-home fall risk monitoring — Continuous assessment between clinic visits
• Intervention targeting — Identifying patients most likely to benefit from balance training
• Treatment response tracking — Objective quantification of gait improvement with dopaminergic therapy or rehabilitation

Expected Contributions

Upon completion, this study will provide:

If validated, the DANU system could democratize quantitative gait assessment — making it available to clinicians and researchers without access to motion capture laboratories.

Related Pages

• [Parkinson's Disease](/diseases/parkinsons-disease)
• [Gait Dysfunction in Parkinson's Disease](/mechanisms/gait-dysfunction-parkinson)
• [Alpha-Synuclein](/proteins/alpha-synuclein)
• [Dopaminergic Neurons](/cell-types/dopaminergic-neurons-snpc)
• [Substantia Nigra](/brain-regions/substantia-nigra)
• [MDS-UPDRS](/diseases/parkinsons-disease)
• [Balance Disorders in Parkinson's Disease](/mechanisms/balance-dysfunction-parkinson)
• [Wearable Sensors in Movement Disorders](/entities/wearable-sensors-movement-disorders)
• [Northumbria University](/institutions/northumbria-university)

External Links

• [ClinicalTrials.gov — NCT07281794](https://clinicaltrials.gov/study/NCT07281794)
• [Northumbria University Faculty of Health and Life Sciences](https://www.northumbria.ac.uk/about-us/academic-departments/health-and-life-sciences/)
• [DANU Sports Ltd](https://www.danusports.com/)

References