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Digital Tools for Assessment of Motor Functions and Falls in ALS

NCT05271435 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-02-13

No results posted yet for this study

Summary

This is a 48-week single arm study that incorporates digital tools for assessing motor function as part of an ALS telemonitoring program. During the study, neck- and wrist-worn "activity sensors" (PAMSys, BioSensics, Newton, MA) that will be worn by subjects while performing tasks of daily living. Subjects will also complete a motor, speech, and handwriting assessment during site visits. Subjects will complete a digital home assessments of speech, handwriting, and pattern tracing tasks throughout the study, and report any falls which occur on the study tablet. The investigators will explore whether functional changes are sensitive to self-reported changes on the ALS Functional Rating Scale - Revised (ALFRS-R) over the length of the study.

Conditions

Interventions

DEVICE

PAMSys Activity Monitoring System

This system is composed of a Study Tablet running custom fall detection and reporting software and PAMSys sensors. PAMSys provides clinical-grade physical activity monitoring, storing the raw accelerometer data that can be used for analyzing activity parameters such as those listed in Table 3. Sensor data will be downloaded manually upon receipt of the study device by Biosensics, the study sponsor. Sensors can be worn during all activities including while showering and sleeping. The rated battery life is 3-6 months for the fall sensor, and 4 weeks for the activity sensors. This system is not classified as a medical device. Reports of sensor use, step number, battery level, and memory availability are sent hourly to a secured and HIPAA compliant back-end server provided by BioSensics. The Study Tablet also contains modules for performing speech, handwriting, and pattern tracing tasks.

BEHAVIORAL

Motor, Speech, and Handwriting Assessment

These assessments occur at each study visit. After equipping the subject with 3 activity sensors (1 on pendant around neck and 2 on wrists). * 10-meter walk task (5 minutes) - The subject starts from a standing position and walks a length of 10 meters. The best time of three trials is used. * Timed Up and Go (TUG) test (5 minutes) - Subjects stand, walk to a marker on the floor 3 meters ahead, turn around the marker, walk back to the chair, and sit. The best time of three trials is used. * Handwriting Assessment Battery (HAB) (15 minutes) \[Faddy2008\] - The subject is seated at a table with a pencil and paper and performs a series of writing tasks. * Speech Assessment Battery (SAB)(10 minutes) - The participant will perform a set of audio recordings using the study tablet while sitting in a quiet room.

Sponsors & Collaborators

  • BioSensics

    collaborator INDUSTRY

  • Milton S. Hershey Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05271435 on ClinicalTrials.gov