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

NCT07491484 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-03-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised

Patient-Reported Functionality Assessment

OTHER

Amyotrophic Lateral Sclerosis Assessment Questionnaire-40

Patient-Reported Quality-of-Life Assessment

Sponsors & Collaborators

  • TidalHealth, Inc.

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-03
Primary Completion
2026-12-31
Completion
2027-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07491484 on ClinicalTrials.gov