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Trial record 2 of 6 for:    als atlis

Longitudinal Study of Outcomes Measures in ALS Trials

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
ALS Association
Information provided by (Responsible Party):
Patricia L. Andres, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01911130
First received: July 10, 2013
Last updated: September 21, 2015
Last verified: September 2015
  Purpose
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.

Condition
Amyotrophic Lateral Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Study Comparing the Responsiveness of Outcomes Measures in ALS Trials

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Accurate Test of Limb Isometric Strength (ATLIS) between each visit [ Time Frame: every 1 to 4 months for up to two years ] [ Designated as safety issue: No ]
    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:
  • Change in ALS Functional Rating Scale - Revised (ALSFRS-R) between each visit [ Time Frame: every 1 to 4 months for up to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Every 1 to 4 months for up to two years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: July 2013
Estimated Study Completion Date: November 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with ALS
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911130

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Massachusetts General Hospital
ALS Association
Investigators
Principal Investigator: Patricia L. Andres, DPT, MS Massachusetts General Hospital
  More Information

Responsible Party: Patricia L. Andres, Senior Research Scientist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01911130     History of Changes
Other Study ID Numbers: 2013P000702 
Study First Received: July 10, 2013
Last Updated: September 21, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
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

ClinicalTrials.gov processed this record on December 02, 2016