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Traditional methods of assessing movement disorders, such as clinical rating scales, are limited to previously available methods of measurement and data collection. While current validated instruments provide objective data, within many therapeutic areas the opportunity exists to capture more granular endpoints related to movement and functional mobility.

Clario’s Opal® V2C precision motion monitoring and measurement platform overcomes these limitations. The Opal sensors capture objective, high-fidelity data interpreted by the embedded analytics Mobility Lab software to deliver scientifically validated quantitative outcome measures specific to the assessment of your patient populations’ functional mobility by capturing digital mobility outcomes across gait, balance and mobility domains including:

  • Lower extremity gait
  • Upper extremity gait
  • Sit/stand postural transition
  • Anticipatory postural adjustment
  • Postural sway
  • Turning
  • Trunk range of motion
  • Lumbar range of motion

Opal V2C system for precision motion measurement — a purpose built solution for movement disorder clinical trials

Clario’s Opal V2C system for motion measurement has been studied and validated across therapeutic areas and clinical indications, including but not limited to:

  • Parkinson’s Disease (PD)
  • Multiple Sclerosis (MS)
  • Spinocerebellar Ataxia (SCA)
  • Friedreich’s Ataxia (FA)
  • Essential Tremor (ET)
  • Multiple System Atrophy (MSA)
  • Huntington’s disease (HD)
  • Progressive Supranuclear Palsy (PSP)
Clario’s Opal V2C system for motion measurement.

Wearable technology has the power to improve trials

Earlier go/no-go decisions

Need fewer patients

Improved precision of motion measurement

Meaningful endpoints for patients

Why choose Clario’s Opal® V2C system for precision motion monitoring in your next clinical trial?

For the past 10 years, more than 1,000 researchers worldwide have used Opal technology to evaluate human movement and patient functional mobility. Our Opal technology has been studied and cited in over 500 scientific publications. Our expert scientific advisory team has generated a body of evidence with over 45,000 scientific citations.

Opal® V2C System: In-clinic active assessments

The outcome measures and endpoints captured by Clario’s Opal V2C System provide objective measurement data to inform more accurate clinical assessments related to disease progression evaluation or treatment efficacy measurement. Sponsors can rely on our medical-grade technology and scientifically validated endpoints to improve clinical trials.

The Opal® V2C System is a complete solution for precision motion monitoring at sites. It combines motion capture sensors, software and data measurement/transfer into one convenient and powerful platform. The integrated precision motion monitoring solution includes 4 core components to support easy implementation to meet study set up timelines:

  • Opal® Sensor: Capture core CNS/Movement Disorder Indications
  • Digital Mobility Outcomes: Proprietary Algorithms Calculate 140+ validated Clinical Outcome Measures
  • Mobility Lab®: Proprietary Motion Analytics Software and Reporting Platform
  • Mobility Exchange: Cloud-Based Clinical Trial Management System for Device/Data Rich Trials

Opal® V2C system features support more efficient clinical trials data capture and measurement including:

  • Precision Motion Monitoring (PerfO) of gait, balance and mobility. Delivers high fidelity data of instrumented standardized assessments from remote and/or in-clinic locations
  • Pre-configured standard assessments of instrumented tests embedded in software with more than 140 validated outcome measures
  • Provision of precision motion analytics through our Mobility Lab software platform that are objective, validated, sensitive and reliable
  • Capture clinically meaningful functional mobility endpoints as related to Quality of Life and Activities of Daily Living
  • Guided patient coaching through the assessment procedure
  • Real-time notification to test administrator indicating acceptable test performance and data capture

Opal® V2C System flexibility for decentralized or hybrid clinical trials: remote active assessments

The Opal® V2C System also supports remote active assessments for precision motion monitoring, giving sponsors the option to conduct standard Mobility Lab® assessments in clinic or at home through our Virtual Visits or other Telehealth platform. The clinician-guided assessments are administered virtually, giving patients the support they need while ensuring sponsors high-quality data collection. Key components specific for remote use include:

  • Opal® DataHub: Used to charge the Opal sensors and transfer data from Opals to the server for near real-time site data
  • Mobility Web App: An easy-to-use application for interacting with clinicians while completing the visual assessment
  • Integration with Clario’s Virtual Visits (provisioned device can be provided)

Passive remote patient monitoring of physical activity: Opal Actigraphy

In addition to active assessments, sponsors seek ways to capture continuous real-world patient activity measures via remote passive monitoring. Clario’s Opal® actigraphy solution quantifies daily physical activity to complement QOL & ePRO data for any trial. Combining objective measurements from wearable sensors with qualitative ePRO creates a comprehensive picture. Data is collected passively from patients wearing a single Opal sensor on their wrist.

Opal Actigraphy measures

  • Activity measures:
    • Duration and bouts of activity
    • Activity intensity

Why choose Clario for precision motion monitoring?

One of the largest validated outcomes library in the industry for gait, balance and functional mobility. The unrivaled precision motion measurement leader

Clario offers an industry-leading library of 140+ scientifically validated outcomes to measure gait, balance and functional mobility across multiple therapeutic areas. These endpoints help sponsors unlock richer insights that deliver meaningful clinical outcomes and transform patients’ lives through better evidence.

Empowering Trial Anywhere™ solutions for in-clinic and at-home

The Opal V2C precision motion analytics platform is designed to support scientific research and clinical trials anywhere, including clinic, hybrid and remote locations. The Opal V2C system supports both clinical and at-home use scenarios by offering an integrated, easy-to-use platform. Innovative devices and software provide a full range of instrumented tests to easily collect quantitative measures of mobility. Whether in-clinic or virtually, Clario’s Opal V2C system provides deeper insights into understanding the impact of disease and therapeutic interventions impact on patient functional mobility. When integrated with Clario’s data capture solutions for cardiac safety, eCOA, digital patient, imaging or respiratory, Clario’s precision motion monitoring solutions provide a seamless end-to-end clinical outcomes data capture system.

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Want to learn more? Contact a precision motion specialist today.