Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-01-13 @ 3:43 PM
Study NCT ID:
NCT02374606
Status:
UNKNOWN
Last Update Posted:
2018-04-03
First Post:
2015-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accurate Test of Limb Isometric Strength (ATLIS) in ALS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-31', 'studyFirstSubmitDate': '2015-02-24', 'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory measure: Electrical impedance myography (EIM) data will be compared to ATLIS data.', 'timeFrame': "every 1 to 4 months according to each patient's site visit schedule", 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Change in Accurate Test of Limb Isometric Strength (ATLIS) between each visit', 'timeFrame': "every 1 to 4 months according to each patient's site visit schedule", 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Change in ALS Functional Rating Scale - Revised (ALSFRS-R) between each visit', 'timeFrame': "every 1 to 4 months according to each patient's site visit schedule", 'description': "This questionnaire consists of 12 questions about the subject's ability to function in certain daily activities. Questions are asked in an interview format."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['outcomes measures', 'strength measurement', 'disease progression'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with ALS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* 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.\n* Capable of providing informed consent and complying with trial procedures.\n* Active movement of at least two limbs at the time of study entry\n* Intend to routinely attend clinic for neurological care at the clinical site\n\nExclusion criteria:\n\n* 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).\n* Patients judged by the site clinical investigator to have significant clinical evidence of unstable medical or psychiatric illness will be excluded.'}, 'identificationModule': {'nctId': 'NCT02374606', 'briefTitle': 'Accurate Test of Limb Isometric Strength (ATLIS) in ALS', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Accurate Test of Limb Isometric Strength (ATLIS) in ALS', 'orgStudyIdInfo': {'id': 'Pro00038868'}}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Fetterman', 'role': 'CONTACT', 'email': 'katherine.fetterman@CSHS.org', 'phone': '310-423-8497'}], 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Ashley Fetterman', 'role': 'CONTACT', 'email': 'katherine.fetterman@cshs.org', 'phone': '310-423-8497'}], 'overallOfficials': [{'name': 'Peggy Allred, PT DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Program Administrator/Neuromuscle Program Manager', 'investigatorFullName': 'Peggy Allred, PT DPT', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}