Actively Recruiting
Measurement and Impact of Physical Impairment in Amyotrophic Lateral Sclerosis Using Digital Technologies - A Precision ALS Project
Led by University of Dublin, Trinity College · Updated on 2025-02-11
60
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Dublin, Trinity College
Lead Sponsor
B
Beaumont Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Amyotrophic Lateral Sclerosis (ALS) is a rare neurodegenerative disease that progressively impairs physical functions such as speaking, breathing, walking, and daily activities. This study focuses on developing and evaluating new digital technologies to more accurately measure physical impairments in people with ALS. It aims to compare these novel tools to traditional assessments and determine their ease of use and acceptability for both patients and healthcare professionals. The study will test a range of digital tools including apps and devices that measure speech intelligibility, tongue and hand strength, dexterity, walking, physical activity, and breathing. Participants will use these technologies at home, with support as needed, alongside three in-person assessments over 12 months. Researchers will compare data from new digital methods with traditional clinical assessments and collect feedback on technology usability through questionnaires and interviews. Participants will engage in weekly home assessments using selected technologies suited to their abilities, along with three face-to-face evaluations either at a clinic or their home. Data collected will be analyzed for adherence, usability, and validity, using both traditional and advanced methods like artificial intelligence. The study will last approximately three years including recruitment, participation, and data analysis, aiming to improve future ALS research and treatment monitoring through digital measurement tools.
CONDITIONS
Brief Title
Measurement and Impact of Physical Impairment in Amyotrophic Lateral Sclerosis: Use of Digital Technologies - A Precision ALS Project
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ALS by a neurologist as possible, lab-supported probable, probable, or definite according to revised El Escorial Criteria
- Enrollment in the Precision ALS prospective study
- Ability to understand participation requirements and provide informed consent
- Willingness to use a smartphone or tablet and download study apps
- Age over 18 years
- Home access to stable broadband internet and willingness to use it for data collection
You will not qualify if you...
- Diagnosis of neurological disease other than ALS, active dementia, or psychiatric illness limiting ability to follow assessments
- Medical conditions that compromise patient safety or limit participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or home visit)
Duration - 1 day
Participants complete baseline demographic and clinical assessments in person, including traditional physical function tests and novel technology assessments conducted by researchers.
1 baseline visit (in-person or home visit)
Duration - 12 months
Participants use digital technologies at home to regularly complete assessments of speech, strength, dexterity, mobility, respiration, and patient-reported outcomes, with support via video or phone calls as needed.
Regular remote assessments as per schedule with ongoing researcher check-ins
Duration - At 3 months and 12 months
Participants complete in-person assessments similar to baseline at 3 months and 12 months to compare traditional and novel measurement methods.
2 visits (in-person or home visits)
Trial Site Locations
Total: 1 location
1
Beaumont Hospital
Dublin, Dublin, Ireland
Actively Recruiting
Research Team
D
Dara Meldrum, PhD
P
Prof. Orla Hardiman, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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