Impact of Physical Functioning on Patient-Reported Outcomes in ALS Patients at TidalHealth

Recruiting now

Conditions studied: Amyotrophic Lateral Sclerosis, Motor Neuron Disease

In brief

Amyotrophic Lateral Sclerosis (ALS) is a fatal neurodegenerative disease in which motor neuron cells of the brain and spinal cord progressively degenerate and die. There is currently a lack of curative treatment for individuals that are diagnosed with ALS. Since treatment options are limited, researchers have placed greater emphasis on evaluating Quality-of-Life (QoL) as it offers perspective into the everyday life of the patient and is sensitive to changes over time. The goal of this longitudinal observational study is to learn more about what factors negatively impact an individual's QoL after they are diagnosed with ALS. Previous research has shown that an individual's level of physical functioning can negatively impact their quality of life, but this may not be the only factor. The main objectives this study are: 1. Assess if there is a statistically significant correlation between patient's functionality scores (ALSFRS-R) and quality of life scores (ALSAQ-40). 2. Determine how disease stage (King's Clinical Severity Staging System) affects correlation between functionality scores (ALSFRS-R) and quality of life scores (ALSAQ-40). Participants will complete a quality-of-life questionnaire (ALSAQ-40) every other time they present to their standard-of-care clinic visits for a period of two years. In parallel, with the functionality rating (ALSFRS-R) scores captured as standard-of-care at every clinic visit.

Key facts

Study ID

NCT07491484

Run by

TidalHealth, Inc.

People needed

30

Starts

2025-07-03

Expected to finish

2027-07-01

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Over the age of 18
• Have a diagnosis of Amyotrophic Lateral Sclerosis of Motor Neuron Disease
• Able to comprehend and willing to sign an informed consent form and comply with study procedures.
• Receiving care at TidalHealth Peninsula Regional Multidisciplinary ALS Clinic

You may not qualify if…

• Unable to read and understand English
• Unwilling or unable to comply with the study procedure, including the presence of any condition that is likely to affect the participant's ability to comply with study procedures.

Where it is running

• TidalHealth Peninsula Regional, Inc. — Salisbury, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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