This observational study (NCT07281794), conducted by Northumbria University in partnership with DANU Sports Ltd, evaluates the clinical validity of the DANU Sports System as a tool for assessing gait and balance in patients with Parkinson's 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[1].
| 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 |
Clinical gait assessment in Parkinson's disease relies heavily on subjective rating scales and observer-dependent measurements. The MDS-UPDRS 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[1:1].
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:
Before a measurement tool can be adopted clinically, its outputs must be validated against established reference standards. This study establishes that validation by:
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 |
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.
The study captures a comprehensive set of spatiotemporal gait parameters as primary outcomes[1:2]:
| 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 |
| 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 |
Controls are age-matched to the PD group and screened for absence of neurological conditions and significant musculoskeletal impairments affecting gait.
Gait dysfunction in Parkinson's disease stems from dopaminergic neuron loss in the substantia nigra pars compacta. The nigrostriatal pathway is critical for:
Loss of dopamine disrupts these functions, producing the characteristic PD gait triad:
Beyond dopaminergic cell loss, alpha-synuclein pathology in non-dopaminergic systems contributes to gait dysfunction:
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.
Quantitative gait metrics have emerged as potential biomarkers for PD progression and treatment response. This study contributes to that pipeline by:
| 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 |
Gait velocity and stride length are among the strongest predictors of falls in Parkinson's disease. A validated wearable system could enable:
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.