Products

LEGSys™

Objective gait analysis in the clinic and at remote study visits.

LEGSys is a portable, FDA-listed wearable system for objective gait assessment. Body-worn inertial sensors capture lower-body motion and calculate gait parameters during standard walking tests, without a fixed gait laboratory.

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FDA ISTAND acceptance for LEGSys-derived foot-drop measures

The FDA ISTAND program has accepted a Letter of Intent for LEGSys-derived foot-drop measures collected during the 6-Minute Walk Test in adults with CMT1A. The proposed use is to assess change over time in clinical trials.

See FDA’s CDER statement (opens in a new tab)

Gait analysis across study settings

Laboratory gait systems and instrumented walkways provide detailed measurements, but their fixed setups can limit assessment locations and walking distance. LEGSys brings quantitative gait assessment to clinical sites and remote visits: research teams can use standard walking tests to measure gait and track changes over time across multisite and decentralized clinical trials.

What LEGSys measures

LEGSys measures lower-body motion during walking and standard functional tests to calculate spatiotemporal and kinematic gait parameters.

  • Standard functional tests

    Built-in modules for walking tests and the Timed Up & Go (TUG).

  • Spatiotemporal gait

    Walking speed, step and stride length, step and stride time, and cadence.

  • Gait phases

    Swing and stance times, double support, and the timing of gait-cycle phases.

  • Gait steadiness

    Step and stride variability to characterize consistency during walking.

  • Joint kinematics

    Sensor-derived motion and range-of-motion estimates for the shanks, thighs, knees, and trunk.

  • Automated reports

    Automatically generated reports with assessment history for comparison with baseline.

Additional parameters (research only)

Study-specific configurations can extend gait analysis to dynamic balance, gait initiation, foot-drop features, and arm motion. Available measures depend on sensor placement and software configuration.

  • Dynamic balance

    Estimated side-to-side and forward-backward center-of-mass sway during walking.

  • Gait initiation

    Steps, distance, and timing needed to transition from standing to steady walking.

  • Foot drop

    Study-specific measures related to reduced foot clearance and ankle motion during swing.

  • Wrist motion during walking

    Wrist-worn sensors characterize arm swing and wrist motion during walking.

Designed for objective clinical assessment

Portable sensors, standard test modules, and automated reports support consistent gait assessment across clinical and remote study settings.

  • Five-sensor set

    Up to five 9-axis inertial sensors on the shanks, thighs, and lower back capture lower-body movement.

  • Automated setup checks

    Algorithms help detect and compensate for supported setup errors; correct placement remains essential.

  • FDA-listed

    FDA-listed for gait assessment, with fall-risk assessment intended for patients aged 70 and older.

  • Portable, no walkway needed

    Assess gait in clinics and study settings with suitable walking space, without a fixed laboratory or instrumented walkway.

  • Configurable measures

    Study-specific versions support additional measures, including foot-drop features and wrist motion during walking.

  • Remote-ready

    Works with BioDigit Home for remote gait assessments, with supervision tailored to participants and study protocols.

LEGSys specifications

LEGSys specifications
Specification Details
Form factor Up to five lightweight wearable sensors with straps, worn on the shanks, thighs, and lower back
Sensors 9-axis IMU per unit (tri-axial accelerometer, gyroscope, and magnetometer)
Sampling rate 100 Hz
Connectivity Wireless data streaming to the host application
Analysis Algorithms calculate spatiotemporal gait and motion measures; outputs depend on sensor and software configuration
Functional tests Built-in modules for Timed Up & Go (TUG) and 6-Minute Walk Test (6MWT)
Error handling Automated checks help identify and compensate for supported setup errors; correct sensor placement remains essential
Configurations Study-specific configurations for foot-drop features and wrist motion during walking
Reporting Automated reports with assessment history for comparison with baseline and tracking change
Deployment In-clinic and remote assessments via BioDigit Home, with supervision appropriate to the protocol
Cloud integration BioDigit Cloud portal with API access; eligible study data may contribute to the BioDigit Database
Regulatory and quality FDA-listed device; ISO 13485 quality management; cloud workflows designed to support HIPAA and GDPR requirements

LEGSys data across disease cohorts

Gait data from selected patient and healthy-control studies can support digital biomarker research through the BioDigit Database. Research and industry partners can explore cohort-specific data access.

  • Healthy controls

    Gait and balance data from participants without the condition under study, supporting comparisons with patient cohorts.

  • Alzheimer's disease

    Walking speed, gait variability, and dual-task performance to study functional impairment and change over time.

  • Charcot-Marie-Tooth disease

    Gait measures to investigate functional impairment in hereditary motor and sensory neuropathy.

  • Corticobasal syndrome

    Test-based gait and balance measures to investigate functional impairment in corticobasal syndrome.

  • Huntington disease

    Gait and balance measures in prodromal and manifest cohorts to explore relationships with disease stage and clinical scores.

  • Progressive supranuclear palsy

    Gait and functional mobility measures to investigate impairment and changes over time.

Available measures, participant counts, follow-up duration, and access terms vary by cohort. Data sharing is subject to study consent and applicable agreements.

LEGSys research and publications

Selected papers and a conference abstract using BioSensics gait and balance technology. Findings apply to the devices, measures, and populations studied.

Part of the BioSensics ecosystem

Combine LEGSys with other BioSensics tools in one study protocol, with supported data streams available through BioDigit Cloud.

  • Balance assessment

    BalanSens

    Wearable balance and postural sway assessment without a force plate.

  • Gait monitoring

    PAMSys Gait

    Continuous real-world gait monitoring with stride-level metrics from an ankle-worn sensor.

  • In-clinic assessment

    BioDigit Clinic

    Speech, video, cognitive, and fine motor assessments at clinical sites in a single multimodal system.

  • Research data

    BioDigit Database

    A research database of digital measures and clinical data across disease cohorts.

Bring gait assessment into your study

Talk with our team about assessment protocols, study deployment, and data access.

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