Amyotrophic Lateral Sclerosis
Conditions
Keywords
outcomes measures, strength measurement, disease progression
Brief summary
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.
Detailed description
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).
Interventions
None listed
Sponsors
ALS Association
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Accurate Test of Limb Isometric Strength (ATLIS) between each visit | every 1 to 4 months for up to two years | ATLIS measures isometric strength in 12 muscle groups in the arms and legs. The subject is tested seated in a specially designed chairs with adjustable uprights. The subject's limb is placed in a standard position and maximal force is exerted on the wireless load cell fixed to the upright. Strength data is digitally captured and expressed as a percentage of expected normal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ALS Functional Rating Scale - Revised (ALSFRS-R) between each visit | every 1 to 4 months for up to 2 years | This questionnaire consists of 12 questions about the subject's ability to function in certain daily activities. Questions are asked in an interview format. |
| Change in Slow Vital Capacity (SVC) between each visit | Every 1 to 4 months for up to two years | SVC measures the amount of air you can exhale following a deep breath. For this test, we will ask you to hold a mouthpiece in your mouth, breathe in deeply, and breathe out as much air as you can, up to 5 times. |
Countries
United States
Outcome results
None listed