For clinical trials
Ambulation and Physical Activity
Continuous wearable measurement of walking, gait speed, posture, and physical activity for clinical trials, captured during everyday life.
BioSensics combines PAMSys pendant sensors for activity and posture with PAMSys Gait ankle sensors for stride-level walking measures. Use either sensor or both, with support for site and home deployment, wear-time monitoring, secure data handling, and automated analysis. Available measures include walking and running bouts, steps, cadence, posture, transitions, and ankle-derived gait speed, stride length, and stride duration. Sensor selection, monitoring periods, wear requirements, and supporting evidence are matched to your study objectives.
PAMSys accepted into the FDA ISTAND program for ambulation measurement in PSP
The FDA ISTAND program has accepted a Letter of Intent for PAMSys-derived ambulation measures as longitudinal outcomes in clinical trials of progressive supranuclear palsy–Richardson syndrome (PSP-RS).
Measure ambulation and physical activity where it matters: everyday life
Clinic-based assessments provide an important snapshot of mobility, while step counts alone describe only part of daily movement. Everyday walking is shaped by environment, fatigue, medication timing, and routines, creating patterns that a brief visit may not capture. BioSensics supports the workflow from device deployment to automated analysis: protocol-selected pendant or ankle-worn sensors, site and home deployment, wear-time monitoring, and secure data handling. PAMSys characterizes posture, transitions, and activity; PAMSys Gait adds stride-level measures such as gait speed. These measures provide longitudinal information interpreted alongside monitoring coverage and study context.
What your study receives
Examples of the data and measures available through this service. The final selection depends on the configured sensors, monitoring periods, and the study design.
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Physical activity and posture measures
Walking and running bouts, steps, cadence, bout duration, step-duration variability, time and percentage in each posture, and postural-transition counts from the pendant.
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Gait and mobility measures
Gait speed, stride length, stride duration, gait speed variability, stride length variability, walking bouts, steps per walking bout, and daily and cumulative step counts from the ankle sensor.
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Coverage and raw data
Estimated wear and nonwear periods for coverage review, per-step timestamps and durations, and raw sensor data where included in the agreed data-delivery scope.
Configured around your protocol
Support from sensor deployment through data analysis for continuous monitoring of walking, posture, and physical activity at study sites and at home.
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Study-configured sensors
PAMSys pendant sensors, PAMSys Gait ankle sensors, or both, selected and configured for the protocol.
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Physical activity and posture
The pendant derives daily activity and posture measures: walking and running bouts, steps and cadence, sit-to-stand and stand-to-sit transitions, and time spent sitting, standing, walking, running, and lying.
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Gait and mobility measures
The ankle sensor derives gait speed, stride length, stride duration, and steps per walking bout from recorded daily-life walking, together with gait variability, walking activity, and step counts.
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Wear-time monitoring
Algorithms estimate wear and nonwear periods to support review of monitoring coverage.
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Research configurations
Research-use-only configurations may address activity intensity, sleep, sleep quality, or fall-related measures, scoped separately from the core monitoring service.
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Centralized data and reporting
BioDigit Cloud brings processed measures and wear-time information into one study environment for review, reporting, and downstream analysis.
Built for regulated clinical research
The service combines controlled data access, security, and traceability to support regulated clinical research. Study-specific requirements and applicable documentation should be reviewed before deployment.
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Device regulatory status
PAMSys is FDA-listed as a Class II device. PAMSys and PAMSys Gait carry medical CE marks; confirm model-specific intended use, applicable EU documentation, and UK registration for the deployment.
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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 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.
Objective ambulation and physical activity endpoints captured continuously in everyday life
PAMSys has been deployed in more than 100 clinical studies across more than 30 countries, including measurement of primary or secondary endpoints in more than 10 clinical trials. Measurement suitability should be assessed for the selected population, configuration, and intended endpoint role.
From protocol to results
A structured workflow connects study configuration, device setup, monitoring, upload, automated analysis, and reporting, with traceable records of study-data activity.
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Configure
Study-specific sensor sets, sampling rates, monitoring periods, users, and workflows are configured before deployment.
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Deploy
Sensors are provided at the study site or shipped to the home, as agreed for the study, with guidance on wear, charging, and data transfer for participants and site staff.
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Monitor and upload
Participants wear the selected sensors during planned monitoring periods. The sensors transfer data over Bluetooth Low Energy to the BioDigit app on the study device, which uploads the data to BioDigit Cloud. The pendant also stores data onboard, so recording continues when the study device is out of range.
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Analyze and report
Algorithms compute configured posture, transition, activity, gait-speed, and stride-level measures from sensor signals, with per-step timestamps and durations available for detected steps. Study teams review processed measures and wear-time information centrally; reports and data delivery, including processed, per-step, or raw-data outputs, export formats, API access, and traceability records, are defined in the study scope.
Service details
| Service element | Details |
|---|---|
| Service | End-to-end ambulation and physical activity monitoring, device management, data management, and automated analysis for clinical trials |
| Capture | Protocol-selected PAMSys pendant sensors, PAMSys Gait ankle sensors, or both, worn during planned monitoring at home and in the community |
| Sensors | Pendant: 3D accelerometer, with 50 Hz specified for the described configuration. Ankle sensor: 9-axis inertial measurement unit (IMU), with 100 Hz as the default. Confirm sampling rates for the selected device versions and protocol |
| Physical activity measures | Walking and running bouts, steps, cadence, bout duration, step-duration variability, time and percentage in each posture, and postural-transition counts; summary statistics depend on the selected measures |
| Gait measures | Gait speed, stride length, stride duration, steps per walking bout, gait speed variability, and stride length variability |
| Research-use-only measures | Research-use-only measures (activity intensity, sleep, sleep quality, and falls), sampling settings, raw-data access, custom analysis, and validation evidence for the intended use are scoped separately. |
| Orientation compensation | Automatic correction for ankle sensor repositioning during daily wear |
| Battery and memory | Battery duration, charging, and storage capacity depend on the device version and configuration. PAMSys Gait provides seven days of battery life at 100 Hz and up to three months depending on configuration and sampling rate. The sensors support onboard storage and wireless charging; confirm the operating duration for each selected sensor |
| Monitoring mode | Continuous sensor recording during planned wear; upload, analysis, and reporting timing depend on configuration |
| Wear-time monitoring | Estimated wear and nonwear periods support review of monitoring coverage. Define valid-wear criteria and missing-data handling up front; nonwear does not mean zero activity |
| Data output | Configured activity and gait measures, with per-step timestamps, durations, and raw sensor data as defined in the agreed data-delivery scope |
| Upload and storage | Centralized upload and storage through BioDigit Cloud; access, exports, and API requirements are defined for the study. Any proposed BioDigit Database contribution is considered separately |
| Reporting | Centralized review of activity and gait measures and wear-time information, with study reports and exports defined for downstream analysis |
| Regulatory | PAMSys: FDA-listed Class II device. PAMSys and PAMSys Gait: medical CE marks. Confirm applicable EU documentation, UK registration, certification scope, electronic-record controls, and privacy requirements for the deployment |
| Support | Study configuration, training, deployment support, and ongoing assistance |
The tools behind the service
Ambulation and physical activity monitoring integrates with BioSensics' full platform. Deploy alongside other digital assessments within the same study protocol, with all data accessible through a single portal.
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Activity monitoring
PAMSys
Pendant sensor for monitoring body posture, postural transitions, physical activity, and walking parameters.
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Gait monitoring
PAMSys Gait
Continuous real-world gait monitoring with stride-level metrics, including gait speed, from a single ankle-worn sensor.
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Upper-limb monitoring
PAMSys ULM
Wrist-worn sensor for monitoring upper-limb activity and hand function during everyday life, deployable alongside the pendant and ankle sensor in one protocol.
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Research data
BioDigit Database
A research resource for disease-specific digital biomarkers. Access and any proposed study-data contribution are considered separately, including permissions, consent, and permitted uses.
Questions to resolve before deployment
Key considerations for selecting assessments, interpreting results, and planning data delivery.
Pendant, ankle sensor, or both?
The pendant characterizes posture, transitions, and physical activity; the ankle sensor adds stride-level gait measures such as gait speed. The choice follows the measures the protocol needs, and the two can be worn together in one study.
How is monitoring coverage handled?
Algorithms estimate wear and nonwear periods. Nonwear flags a potential data gap but not its cause, so it is not treated as zero activity. Valid-wear criteria and missing-data handling are defined for each study, and interpretation accounts for factors such as prescribed device removal, device issues, and wear requirements.
Are data available in real time?
No. Continuous recording does not imply immediate upload, analysis, or study-team review; data transfer over Bluetooth Low Energy to the BioDigit app, upload to BioDigit Cloud, and review follow the configured schedule.
How do everyday measures relate to clinic tests?
Everyday walking is shaped by environment, fatigue, medication timing, and routines, so wearable measures complement rather than replace assessments collected at scheduled visits; measurement suitability is assessed for the selected population, configuration, and intended endpoint role.
How are data accessed and delivered?
Configured activity and gait measures, with per-step timestamps, durations, and raw sensor data where included, are stored in BioDigit Cloud for authorized study-team access. Exports, API requirements, and report timing are defined for the study; any proposed BioDigit Database contribution is considered separately.
Related endpoints
Ambulation and physical activity monitoring is often paired with other digital measures collected in the same study.
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Gait and Balance
Instrumented and video-based gait and balance tests at visits, complementing everyday walking measures.
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Fall Monitoring
Fall detection and monitoring with the PAMSys Fall wearable, from the same sensor family.
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Physiological Monitoring
Heart rate, SpO2, and skin temperature from compatible study-configured smartwatches, with availability and recording schedules dependent on the selected device. Deploy alongside PAMSys sensors.
Bring real-world ambulation and activity endpoints to your trial
Discuss the monitoring period, sensor configuration, measures, supporting evidence, and data-delivery requirements for your clinical trial with BioSensics.