For clinical trials
Hand and Upper-Limb Function
Digital assessment and wearable monitoring of hand and upper-limb function for clinical trials, in the clinic, at home, and during everyday life.
BioSensics combines digital fine motor tasks, video hand opening time (vHOT), instrumented upper-limb tests, and PAMSys ULM monitoring, with secure data handling and scoring tailored to each assessment. Tasks include finger tapping, handwriting, spiral drawing, hand opening, the instrumented Nine-Hole Peg Test, finger-to-nose, elbow flexion and extension, and hand supination and pronation. Assessments, equipment, scoring methods, monitoring periods, supervision, and supporting evidence are matched to your study objectives.
Upper-limb measures used as secondary endpoints in drug trials
PAMSys ULM is being used as a secondary endpoint in drug trials, complementing clinician-rated scales with continuous measures of upper-limb activity and hand function captured during daily life.
Connect structured upper-limb assessments with everyday hand use
Hand and upper-limb function supports independence in daily life. Structured clinical tests characterize performance under defined conditions, while wearable monitoring adds information about movement between visits. BioSensics supports a connected workflow for assessment, monitoring, and analysis: digital fine motor tasks, video-based and instrumented tests, and PAMSys ULM monitoring of goal-directed movements. These approaches provide complementary information about dexterity, movement characteristics, and everyday hand use. Scoring methods and supporting evidence are specific to the selected task, device, population, and intended endpoint use.
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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Task scores and timings
Scores and timings from digital fine motor and video-based assessments, including vHOT scored by trained raters, automated video analysis, or both.
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Instrumented movement measures
Configured measures from the instrumented Nine-Hole Peg Test, finger-to-nose, elbow flexion and extension, and hand supination and pronation tests, with sensors and outputs selected for each assessment.
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Everyday hand-use measures
Goal-directed movement counts and movement characteristics from PAMSys ULM monitoring between visits, with wear-time information to support coverage review.
Configured around your protocol
Support for administering, managing, and analyzing hand and upper-limb assessments, from scheduled tests at sites or at home to continuous monitoring in everyday life.
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Digital fine motor assessments
Finger tapping, handwriting, and spiral drawing tasks administered through BioDigit Clinic or BioDigit Home, with task instructions, equipment, supervision, and scoring methods defined for the protocol and setting.
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Video-based assessments
Video hand opening time (vHOT) tasks recorded using standardized procedures and scored by trained raters, automated video analysis, or both.
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Instrumented upper-limb assessments
Instrumented versions of the Nine-Hole Peg Test, finger-to-nose test, elbow flexion and extension, and hand supination and pronation, with sensor configuration and reported measures specific to each assessment.
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Continuous at-home monitoring
PAMSys ULM wrist-worn sensors support monitoring of everyday hand use, with deep-learning models identifying goal-directed movements and deriving counts and movement characteristics.
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Centralized data and reporting
BioDigit Cloud brings assessment results, monitoring 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. Device documentation, software validation, and study-specific requirements should be reviewed before deployment.
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Device regulatory documentation
Review model-specific CE-marking documentation and UK registration for PAMSys ULM. Confirm the regulatory status and intended use of the other instruments selected for the study separately.
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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.
From protocol to results
A structured workflow connects study configuration, assessments, wearable monitoring, secure upload, scoring and analysis for each assessment type, and reporting, with traceable study records.
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Configure
Assessment batteries, equipment, video protocols, sensor settings, monitoring periods, and schedules are configured before deployment, with supervision, scoring, quality review, and data-delivery requirements defined for the study.
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Assess
Participants perform the selected tasks using the appropriate study device, camera, or sensors. Site staff or remote supervisors provide assistance according to the task instructions and protocol.
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Monitor
Participants wear PAMSys ULM during planned monitoring periods between visits, and analysis derives hand-movement measures from recorded data; any additional activity or sleep outputs depend on the selected sensor and analysis configuration.
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Analyze and report
Assessment and sensor data are transferred to BioDigit Cloud through the configured upload workflow, and the scoring method selected for each task is applied: trained-rater scoring, automated analysis, or both, with video-score comparisons following study-defined review procedures. Study teams review assessment results, monitoring measures, and wear-time information centrally; reports, exports, raw-data access, and any API requirements are defined in the study scope.
Service details
| Service element | Details |
|---|---|
| Service | Protocol-selected hand and upper-limb assessments and wearable monitoring, with data management and modality-specific scoring and analysis for clinical trials |
| Assessment modalities | Digital fine motor assessments, video-based assessments, instrumented upper-limb tests, and continuous wearable monitoring |
| Fine motor assessments | Finger tapping, handwriting, and spiral drawing tasks on the study device |
| Video-based assessments | Video hand opening time (vHOT) tasks recorded using standardized procedures; trained-rater scoring, automated video analysis, or both, with comparison and discrepancy review defined for the study |
| Instrumented assessments | Instrumented Nine-Hole Peg Test, finger-to-nose test, elbow flexion and extension, and hand supination and pronation; sensors, outputs, and procedures selected for each assessment |
| Continuous monitoring | PAMSys ULM wrist-worn sensor with a three-axis accelerometer and onboard storage; 50 Hz used in published research configurations. Deep-learning analysis derives goal-directed movement (GDM) counts and characteristics. Available measures depend on the device, software, and protocol |
| Settings | Clinic assessment through BioDigit Clinic, home assessment through BioDigit Home, and planned wearable monitoring between visits; equipment and supervision requirements depend on the selected modality |
| Battery and memory | Wearable battery duration, charging requirements, and onboard storage capacity depend on the device version and recording configuration; confirm these separately for the planned monitoring period |
| Monitoring mode | Continuous recording during planned wear; upload, analysis, and study-team review follow separate schedules and do not necessarily occur in real time |
| Wear-time monitoring | Estimated wear and nonwear periods support coverage review. Define valid-wear criteria, missing-data handling, and assessment-completion records; nonwear is not zero movement |
| Data output | Task results and scores where applicable, processed GDM features, and raw sensor data where included in the agreed data-delivery scope |
| 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 | Centralized review of assessment results, monitoring measures, and wear-time information, with study reports and exports defined for downstream analysis |
| Regulatory | Review device-specific CE-marking documentation and UK registration, quality and information-security certification scope, software validation, electronic-record controls, and applicable privacy requirements for the deployment |
| Support | Study configuration, training, deployment support, and ongoing assistance |
The tools behind the service
Hand and upper-limb 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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Upper-limb monitoring
PAMSys ULM
The wrist-worn sensor and deep-learning models that detect and characterize the hand's goal-directed movements in everyday life.
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Video analysis
BioDigit Video
Software for automated analysis of eligible video recordings, including selected hand and upper-limb tasks, with outputs defined for the study.
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At-home assessment
BioDigit Home
A connected home workflow for selected fine motor, speech, video, cognitive, and participant-reported assessments, with separate instruments and data-transfer arrangements where required.
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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.
Is the vHOT scored by raters or automatically?
Both are available. Trained-rater scoring, configured automated analysis, or both can be used, with automated scoring serving as a quality check where the study uses both; comparison and discrepancy review follow study-defined procedures.
Can the fine motor tasks be done at home?
Yes. Finger tapping, handwriting, and spiral drawing run on BioDigit Home as well as BioDigit Clinic, with task instructions, equipment, supervision, and scoring methods defined for each setting.
What does PAMSys ULM measure between visits?
Deep-learning models identify goal-directed movements from the wrist-worn sensor and derive counts and movement characteristics of everyday hand use. Available outputs and supporting evidence depend on the selected software, configuration, and study population, and wear-time information supports coverage review; nonwear is not zero movement.
How are data accessed and delivered?
Task results and scores, processed goal-directed movement features, and raw sensor data where included are managed in BioDigit Cloud for authorized study-team access. Upload workflows, exports, API requirements, and report timing are defined for the configuration; research-database access and any proposed contribution are discussed separately.
Related endpoints
Hand and upper-limb assessment is often paired with other digital measures collected in the same study.
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Cognition
Cognitive tasks with automated scoring, run on the same BioDigit Clinic and BioDigit Home platform as the fine motor tasks.
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Ambulation and Physical Activity
Everyday walking, posture, and activity monitoring with the PAMSys pendant and ankle sensors, deployable alongside PAMSys ULM in one protocol.
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Patient-Reported Outcomes
The participant's own report of symptoms and function, adding their perspective to hand and upper-limb measures.
Bring hand and upper-limb assessment into your clinical trial
Discuss assessment types, monitoring periods, scoring methods, supporting evidence, and data-delivery requirements for your clinical trial with BioSensics.