Digital Tools for Assessment of Motor Functions and Falls in ALS

NCT05271435 | Active Not Recruiting

• 1 other identifier: STUDY13892
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

ALS; PLS; PMA

Outcome Measures

Primary Outcomes (1)

• Change in Physical Activity at 10 months

  Changes in physical activity from baseline to 10 months will be assessed. Physical activity will be quantified by measuring number of taken steps per day and will be measured using a validated wearable sensor named PAMSys. Monitoring of physical activity will be done during 72 hours at baseline and 72 hours at 10 months.

  baseline and visit 4 (an average of 10 months)

Secondary Outcomes (25)

• Change from baseline in total lower limb muscle strength at end of study

  baseline and end of study (an average of 1 year)

• Change from baseline in total upper limb muscle strength at end of study

  baseline and end of study (an average of 1 year)

• Change from baseline in total upper limb reflexes at end of study

  baseline and end of study (an average of 1 year)

• Change from baseline in total lower limb reflexes at end of study

  baseline and end of study (an average of 1 year)

• Change from baseline in Forced Vital Capacity at end of study

  baseline and end of study (an average of 1 year)

Interventions

Motor, Speech, and Handwriting Assessment BEHAVIORAL

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.

PAMSys Activity Monitoring System DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with motor neuron disease experiences changes in their walking.

You may qualify if:

• Diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria \[Brooks2000\], primary lateral sclerosis (PLS), or progressive muscular atrophy (PMA).
• years of age or older;
• ALSFRS-R walking sub-score of either 4 (normal gait), 3 (early ambulation difficulties), or 2 (walking with assistance);
• Fluent in written and spoken English.

You may not qualify if:

• Pregnant or nursing woman;
• Prisoner or institutionalized individuals;
• Have any clinically relevant medical history of other disease or diseases that, in the opinion of the research team, exclude the subject from participation (including severe cognitive dysfunction).

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• BioSensics: collaborator

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor, Dept of Neurosurgery

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: March 9, 2022
• Study Start: October 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)