For clinical trials
Gait and Balance
Digital assessment and wearable monitoring of gait and balance for clinical trials, in the clinic, at home, and during everyday life.
BioSensics combines LEGSys and BalanSens sensor-based assessments, BioDigit Video gait analysis, and PAMSys Gait monitoring of everyday walking. Supported assessments include timed and distance-based walk tests, Timed Up and Go, the 6-Minute Walk Test, and standard balance tasks. Tests, sensor configurations, monitoring periods, equipment, supervision, and supporting evidence are matched to your study objectives.
FDA accepts Letter of Intent for LEGSys foot-drop measures in CMT1A
FDA has accepted a Letter of Intent into the FDA ISTAND program for the proposed use of LEGSys-derived foot-drop metrics collected during the 6-Minute Walk Test as longitudinal outcome measures in adults with CMT1A.
Connect structured gait and balance assessments with everyday walking
Timed clinical tests and laboratory assessments characterize mobility under defined conditions, while wearable monitoring adds information about walking between visits. BioSensics supports a connected workflow for assessment, monitoring, and analysis: instrumented gait and balance tests with LEGSys and BalanSens, video-based gait analysis with BioDigit Video, and everyday walking measurements with PAMSys Gait. These approaches provide complementary information about gait and postural control. Measurement evidence, administration requirements, and endpoint suitability depend on the selected task, device, population, and setting; gait and sway measures alone do not establish a validated fall-risk prediction.
What your study receives
Examples of the data and measures available through this service. The final selection depends on the configured assessments and the study design.
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Gait measures
Instrumented tests provide gait speed, stride length and time, cadence, gait phases, variability, and kinematics, depending on the sensor set and analysis. Standardized walking videos provide the gait measures selected for video analysis.
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Postural-sway measures
Estimated center-of-mass motion, anterior-posterior and medial-lateral sway, sway velocity and area, ankle and hip angles, and postural strategy, depending on the task and configuration.
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Everyday walking measures
Stride-level measures, including gait speed, from free-living walking between clinic visits, with wear-time information to support coverage review.
Configured around your protocol
Support for administering, managing, and analyzing gait and balance assessments, from instrumented and video-based tests at sites or at home to continuous monitoring of everyday walking.
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Instrumented gait assessment
LEGSys sensor systems derive spatiotemporal, gait-phase, gait-steadiness, and kinematic measures during protocol-selected tests.
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Instrumented balance assessment
BalanSens sensors estimate center-of-mass sway, ankle and hip motion, and postural strategy during defined balance tasks.
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Video-based gait analysis
Standardized walking videos are analyzed with BioDigit Video for configured gait measures, with recording eligibility, privacy procedures, and any human review defined for the study.
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Continuous at-home gait monitoring
PAMSys Gait uses an ankle-worn sensor to derive stride-level measures, including gait speed, from free-living walking between clinic visits. Battery life is seven days at 100 Hz and up to three months, depending on configuration and sampling rate.
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Standardized test protocols
Built-in modules support timed and distance-based walk tests, Timed Up and Go, the 6-Minute Walk Test, and standard balance tasks. Test conditions, instructions, video procedures, assistance, and supervision are standardized for the protocol and setting.
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Centralized data and reporting
Assessment, video, and monitoring data are managed in a central study environment through BioDigit Cloud, with study reports and participant history across visits for longitudinal comparison.
Built for regulated clinical research
The service combines controlled data access, security, and traceability to support regulated clinical research. Device documentation, software validation, and study-specific requirements should be reviewed before deployment.
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Device regulatory status
LEGSys and BalanSens are FDA-listed devices. Listing is distinct from FDA clearance or approval. Confirm current model-specific status, intended use, and documentation for every device selected for the study.
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Platform validation
Cloud-based study-data collection and management, with validation documentation reviewed for the software version, intended use, and configuration.
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21 CFR Part 11 and Annex 11
Review how configured electronic records and signatures support applicable 21 CFR Part 11 and EU Annex 11 requirements.
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Quality and information security
Quality and information-security controls support study operations. Confirm current ISO 13485 and ISO 27001 certification status and applicable scope.
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HIPAA and GDPR
Privacy and security controls support the handling of participant assessment and monitoring data, with applicable HIPAA and GDPR requirements reviewed for the study.
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Audit trail and authorized access
Audit records support traceability of study-data activity, with role-based access controls governing who can view and share results.
Gait and balance measured in the clinic, at home, and throughout everyday life
Instrumented tests, video-based gait analysis, and continuous monitoring provide complementary views of mobility; the equipment, supervision, and measures depend on the selected assessment and setting.
From protocol to results
A structured workflow connects study configuration, gait and balance assessments, wearable monitoring, secure upload, analysis for each assessment type, and reporting, with traceable study records.
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Configure
Sensor sets, test and video protocols, monitoring periods, and schedules are configured before deployment, with equipment, supervision, safety procedures, quality review, and data-delivery requirements defined for the study.
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Assess
Participants perform the selected walking and balance tasks using the appropriate sensors or video setup. Site staff or remote supervisors provide protocol-defined instructions and assistance, with safety and supervision appropriate to the participant and setting.
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Monitor
Participants wear the PAMSys Gait ankle sensor during planned monitoring periods between visits. Analysis derives measures from detected walking and uses wear-time information to support coverage review.
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Analyze and report
Assessment, video, and monitoring data are transferred to BioDigit Cloud through the configured upload workflows, and task-specific analysis derives the configured gait and postural-control measures from eligible data. Study teams review results centrally, with participant history for longitudinal comparison; reports, exports, raw-data access, and any API requirements are defined for the study.
Service details
| Detail | Description |
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| Service | End-to-end gait and balance assessment, continuous gait monitoring, data management, and automated analysis for clinical trials |
| Assessment modalities | Instrumented gait assessment, instrumented balance assessment, video-based gait analysis, and continuous wearable gait monitoring |
| Instrumented gait assessment | LEGSys: protocol-selected inertial sensors, with 100 Hz used in published configurations and up to five sensors on the shanks, thighs, and lower back. Available measures include gait speed, stride length and time, cadence, gait phases, variability, and kinematics, depending on the sensor set and analysis |
| Instrumented balance assessment | BalanSens: two motion sensors on the shin and waist, with more than 17 measures across its analysis capabilities, including estimated center-of-mass motion, anterior-posterior and medial-lateral sway, sway velocity and area, ankle and hip angles, and postural strategy; outputs depend on the task and configuration |
| Video-based gait analysis | Standardized walking videos collected in the clinic or remotely; configured automated measures from eligible recordings, with privacy procedures, human scoring, and review responsibilities defined for the study |
| Continuous gait monitoring | PAMSys Gait: one ankle-worn sensor with a customizable 100 Hz default sampling rate; stride-level measures from detected walking. Battery life is seven days at 100 Hz and up to three months, depending on configuration and sampling rate. Wear-time information supports coverage review |
| Functional tests | Built-in modules for timed and distance-based walk tests, Timed Up and Go (TUG), the 6-Minute Walk Test (6MWT), and standard balance tasks; protocol-defined video walking tasks |
| Settings | Clinic, bedside, field, or home collection as appropriate to the selected assessment, including remotely supervised workflows; equipment, assistance, safety, and supervision requirements are defined for each task and setting |
| Research configurations | Research configurations may address dynamic balance during walking, gait initiation, foot drop, or wrist kinematics. Available outputs, research-only limitations, and evidence for the intended use are scoped separately |
| Error handling | LEGSys algorithms support detection and correction of certain setup errors, including sensor misplacement; supported conditions and residual quality-review requirements depend on the configuration |
| Wear-time monitoring | Wear-time information supports monitoring-coverage review. Define valid-wear criteria and missing-data handling; nonwear is not zero walking activity |
| Upload and storage | Centralized study-data management through BioDigit Cloud; upload, access, export, and API requirements defined for the configuration. Any proposed BioDigit Database contribution requires separate discussion |
| Reporting | Study reports and participant history for longitudinal comparison, with centralized review of monitoring measures and wear-time information; export formats and delivery timing defined for the study |
| Regulatory | LEGSys and BalanSens are FDA-listed; listing does not establish clearance or approval. Review device-specific status, certification scope, software validation, electronic-record controls, and applicable privacy requirements for the selected deployment |
| Support | Study configuration, training, deployment support, and ongoing assistance |
The tools behind the service
Gait and balance assessments can run alongside other digital assessments within a configured BioSensics study workflow, with centralized access to the selected study data.
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Gait assessment
LEGSys
Wearable gait analysis providing configured spatiotemporal, gait-phase, gait-steadiness, and kinematic measures, with evidence assessed for the intended study use.
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Balance assessment
BalanSens
Portable, sensor-based assessment of postural sway and balance, with estimated center-of-mass and ankle/hip motion measures for selected tasks.
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Gait monitoring
PAMSys Gait
Everyday gait monitoring with an ankle-worn sensor, deriving stride-level measures from detected walking during planned wear.
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Research data
BioDigit Database
A research resource for disease-specific digital biomarkers. Discuss access and any proposed study-data contribution separately, including permissions, consent, and permitted uses.
Questions to resolve before deployment
Key considerations for selecting assessments, interpreting results, and planning data delivery.
How do sensor-based and video-based gait measures differ?
Instrumented tests use body-worn LEGSys sensors and produce spatiotemporal, gait-phase, and kinematic measures; video-based tests use standardized walking videos analyzed with BioDigit Video for configured measures. The two have different capture requirements, privacy procedures, and outputs, and are not interchangeable.
Can participants complete assessments at home?
Yes, for suitable tests. Remote and remotely supervised administration is supported through BioDigit Home, and standardized walking videos can also be captured remotely for video-based gait analysis. Test suitability, sensor or video setup, required assistance, and safety arrangements are confirmed for the study population during planning.
Is continuous monitoring part of the service?
Yes, where the protocol includes it. PAMSys Gait monitoring between visits is configured alongside the structured tests, with monitoring periods, valid-wear criteria, and missing-data handling defined for the study. Not every stride or monitoring period yields usable data, nonwear is not zero walking activity, and continuous recording does not imply immediate upload or review.
Are sensor-based balance measures equivalent to force-plate outputs?
No. BalanSens measures are portable, sensor-derived estimates of center-of-mass motion and sway; they do not directly measure ground-reaction forces and are not interchangeable with force-plate outputs.
How are data accessed and delivered?
Assessment, video, and monitoring data are managed in BioDigit Cloud for authorized study-team access. Upload workflows, exports, raw-data access, report timing, and any API requirements are defined for the configuration; research-database access and any proposed contribution are discussed separately.
Related endpoints
Gait and balance assessment is often paired with other digital measures collected in the same study.
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Ambulation and Physical Activity
Continuous monitoring of everyday walking and physical activity with PAMSys wearables between visits.
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Fall Monitoring
Fall detection and monitoring with the PAMSys Fall wearable, complementing gait and balance measures.
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Patient-Reported Outcomes
The participant's own report of mobility, symptoms, and function, adding their perspective to gait and balance measures.
Bring gait and balance assessment into your clinical trial
Discuss assessment types, monitoring periods, supervision, planned measures, supporting evidence, and data-delivery requirements for your clinical trial with BioSensics.