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Accurate Test of Limb Isometric Strength (ATLIS) in ALS

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ClinicalTrials.gov Identifier: NCT02374606
Recruitment Status : Recruiting
First Posted : March 2, 2015
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Peggy Allred, PT DPT, Cedars-Sinai Medical Center

Brief Summary:
A 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 investigator will compare ATLIS data with data from the commonly used ALS outcomes measure, the ALS Functional Rating Scale-Revised (ALSFRS-R), as well as an exploratory measure, electrical impedance myography (EIM), in a prospective, longitudinal study. Both outcomes measures will be performed on 100 subjects collected preferably at bi-monthly clinic visits during the study period.

Condition or disease
Amyotrophic Lateral Sclerosis

Detailed Description:
Cedars-Sinai Medical Center will enroll and collect data on 100 subjects. Subjects will ideally be tested every 1 to 4 months according to each patient's site visit schedule. Subjects will be tested at each visit using ATLIS, the ALSFRS-R questionnaire and EIM.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accurate Test of Limb Isometric Strength (ATLIS) in ALS
Study Start Date : March 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020





Primary Outcome Measures :
  1. Change in Accurate Test of Limb Isometric Strength (ATLIS) between each visit [ Time Frame: every 1 to 4 months according to each patient's site visit schedule ]
    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 Outcome Measures :
  1. Change in ALS Functional Rating Scale - Revised (ALSFRS-R) between each visit [ Time Frame: every 1 to 4 months according to each patient's site visit schedule ]
    This questionnaire consists of 12 questions about the subject's ability to function in certain daily activities. Questions are asked in an interview format.


Other Outcome Measures:
  1. Exploratory measure: Electrical impedance myography (EIM) data will be compared to ATLIS data. [ Time Frame: every 1 to 4 months according to each patient's site visit schedule ]
    EIM evaluates how electrical current flows through muscle which assists in determining muscle health by measuring electrical current in muscle. 14 muscle groups in the arms and legs will be tested in this study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with ALS
Criteria

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.
  • Active movement of at least two limbs at the time of study entry
  • Intend to routinely attend clinic for neurological care at the clinical site

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).
  • Patients judged by the site clinical investigator to have significant clinical evidence of unstable medical or psychiatric illness will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374606


Contacts
Contact: Ashley Fetterman 310-423-8497 katherine.fetterman@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Ashley Fetterman    310-423-8497    katherine.fetterman@CSHS.org   
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Peggy Allred, PT DPT Cedars-Sinai Medical Center

Responsible Party: Peggy Allred, PT DPT, Research Program Administrator/Neuromuscle Program Manager, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02374606     History of Changes
Other Study ID Numbers: Pro00038868
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Peggy Allred, PT DPT, Cedars-Sinai Medical Center:
outcomes measures
strength measurement
disease progression

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases