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NCT05271435 · ClinicalTrials.gov registry record
Digital Tools for Assessment of Motor Functions and Falls in ALS
A clinical trial of ALS and PLS, sponsored by Milton S. Hershey Medical Center.
- Active
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT05271435: Active study of ALS and PLS, sponsored by Milton S. Hershey Medical Center.
NCT05271435 is a study of ALS and PLS that is active but no longer recruiting, run by Milton S. Hershey Medical Center. The registered enrollment target is 20 participants, below the 1,036-participant average among 19 other ALS trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05271435, a study of ALS and PLS, is active but no longer recruiting, sponsored by Milton S. Hershey Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Interventions
- DEVICE PAMSys Activity Monitoring System
- BEHAVIORAL Motor, Speech, and Handwriting Assessment
Study Locations (1)
Pennsylvania
- Milton S. Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2026-06-30 |
What the registry record for NCT05271435 still lists
NCT05271435 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,036-participant average among 19 other ALS trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with ALS appearing as the primary indexed condition, and to 2 interventions - of which PAMSys Activity Monitoring System is the first listed.
NCT05271435 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05271435 about?
NCT05271435 is a clinical study titled "Digital Tools for Assessment of Motor Functions and Falls in ALS". 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. S...
What is the current status of trial NCT05271435?
This trial is currently active not recruiting. The enrollment target is 20 participants. The study started on 2021-10-01. Estimated completion is 2026-06-30.
What conditions does trial NCT05271435 study?
This clinical trial studies the following conditions: ALS, PLS, PMA.
What interventions are being tested in trial NCT05271435?
The interventions under investigation include: PAMSys Activity Monitoring System (DEVICE), Motor, Speech, and Handwriting Assessment (BEHAVIORAL).
Who is sponsoring clinical trial NCT05271435?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05271435 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05271435's enrollment target sits among peer trials
20 17th of 19 higher than 3 of 19 other ALS trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other ALS trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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