Digital Tools for Assessment of Motor Functions and Falls in ALS
Completed
Conditions studied: ALS, PLS, PMA
In brief
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.
Key facts
- Study ID
- NCT05271435
- Run by
- Milton S. Hershey Medical Center
- People needed
- 20
- Starts
- 2021-10-01
- Expected to finish
- 2026-06-25
- Last updated by the study team
- 2026-06-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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).
- 18 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…
- Neurological or orthopedic problems independent of their inclusionary diagnosis that affects their gait;
- 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).
Where it is running
- Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Full record on ClinicalTrials.gov
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