Longitudinal Study of Outcomes Measures in ALS Trials
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 3/24/2017 |
| Start Date: | July 2013 |
| End Date: | March 2016 |
Longitudinal Study Comparing the Responsiveness of Outcomes Measures in ALS Trials
A new strength measurement device called Accurate Test of Limb Isometric Strength (ATLIS)
was developed to precisely and conveniently measure static limb strength in patients with
ALS. The investigators will compare ATLIS data with data from two commonly used ALS outcomes
measures, the ALS Functional Rating Scale-Revised (ALSFRS-R) and slow vital capacity (SVC)
in a prospective, longitudinal study. All three outcomes measures will be performed on 100
subjects collected preferably at bi-monthly clinic visits during the study period.
was developed to precisely and conveniently measure static limb strength in patients with
ALS. The investigators will compare ATLIS data with data from two commonly used ALS outcomes
measures, the ALS Functional Rating Scale-Revised (ALSFRS-R) and slow vital capacity (SVC)
in a prospective, longitudinal study. All three outcomes measures will be performed on 100
subjects collected preferably at bi-monthly clinic visits during the study period.
Four sites will participate in data collection for this study and will enroll approximately
20-30 subjects per site. Subjects will be tested every 1 to 4 months for up to two years.
Subjects will be tested at each visit using ATLIS, ALSFRS-R questionnaire and slow vital
capacity testing.
Inclusion criteria:
- Subjects 18 years or older diagnosed with clinically possible, laboratory supported
probable, probable or clinically definite ALS according to the World Federation of
Neurology Revised El Escorial Criteria.
- Capable of providing informed consent and complying with trial procedures.
Exclusion criteria:
- Patients, judged by the site clinical investigator to have medical conditions that may
limit their ability to safely exert maximal force using the muscles in their arms and legs
will be excluded from this study (e.g. unstable hypertension, significant cardiac disease,
significant musculoskeletal disorders, or other medical conditions).
20-30 subjects per site. Subjects will be tested every 1 to 4 months for up to two years.
Subjects will be tested at each visit using ATLIS, ALSFRS-R questionnaire and slow vital
capacity testing.
Inclusion criteria:
- Subjects 18 years or older diagnosed with clinically possible, laboratory supported
probable, probable or clinically definite ALS according to the World Federation of
Neurology Revised El Escorial Criteria.
- Capable of providing informed consent and complying with trial procedures.
Exclusion criteria:
- Patients, judged by the site clinical investigator to have medical conditions that may
limit their ability to safely exert maximal force using the muscles in their arms and legs
will be excluded from this study (e.g. unstable hypertension, significant cardiac disease,
significant musculoskeletal disorders, or other medical conditions).
Inclusion Criteria:
- 18 years or older
- clinically possible, laboartory supported probable, probable or clinically definite
ALS according to El Escorial Criteria
- capable of providing informed consent
Exclusion Criteria:
- persons with medical conditions that would limit their ability to safely exert
maximal force using muscles in their arms and legs (e.g. unstable cardiac,
musculoskeletal, or other medical conditions)
We found this trial at
5
sites
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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