Status:
ACTIVE_NOT_RECRUITING
Digital Tools for Assessment of Motor Functions and Falls in ALS
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
BioSensics
Conditions:
ALS
PLS
Eligibility:
All Genders
18+ years
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" (PAM...
Detailed Description
Many of the recognized intrinsic factors for falls are commonly seen in ALS, including advanced age, muscle weakness, gait and balance problems, and previous falls. The American Academy of Neurology A...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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).
Exclusion
Key Trial Info
Start Date :
October 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05271435
Start Date
October 1 2021
End Date
September 30 2025
Last Update
January 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033