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"].
| 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](/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].
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[@nct]:
| 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](/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:
Beyond dopaminergic cell loss, [alpha-synuclein](/proteins/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.