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Assessment of Postural Orientation and Equilibrium In Early Amyotrophic Lateral Sclerosis (ALS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00956501
First Posted: August 11, 2009
Last Update Posted: August 2, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mohammed Sanjak, Carolinas Healthcare System
  Purpose
The purpose of this pilot study is to characterize changes in postural orientation and equilibrium in early diagnosed ALS patient. The investigators plan to cross validate the use of a standardized test of equilibrium (EquiTest, Computerized Dynamic Posturography - CDP) in early diagnosed ALS patients.

Condition
Amyotrophic Lateral Sclerosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessment of Postural Orientation and Equilibrium In Early Amyotrophic Lateral Sclerosis (ALS)

Resource links provided by NLM:


Further study details as provided by Mohammed Sanjak, Carolinas Healthcare System:

Primary Outcome Measures:
  • SOT equilibrium scores on conditions 1-6. [ Time Frame: 9 monthes ]

Secondary Outcome Measures:
  • MSS on conditions 1-6 Weight Symmetry Score on conditions 1-6 DGI score TUG score POMA-B score [ Time Frame: 9 months ]

Enrollment: 35
Study Start Date: February 2009
Study Completion Date: February 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Amyotrophic Lateral Sclerosis
Criteria

Inclusion Criteria:

Inclusion Criteria for subjects with early ALS:

  • Probable or definite ALS according to World Federation of Neurology diagnostic criteria4.
  • Early stage ALS defined as presence of:

    1. Normal lower extremities muscle strength (≥ 4/5 in manual muscle strength or ≥ 80% in the computerized dynamometer quantitative muscle strength);
    2. ALSFRS score of ≥ than 30;
    3. FVC of ≥75% predicted;
    4. Ambulatory without the use of any assistive device.
  • 18 - 75 years of age.
  • Able to provide informed consent.

Inclusion Criteria for control subjects:

  • Healthy 18 - 75 years of age without significant medical condition as defined by the investigator.
  • Able to provide informed consent.
  • Not having any of the exclusion criteria listed below.

Exclusion Criteria:

  • Age < 18 or > 75 years.
  • History of falls (2 or more in the last year), history of fainting, history of cerebrovascular accident (CVA) or myocardial infarction (MI), history of lower limb joint replacement.
  • History of neuromuscular dysfunction "except diagnosis of ALS for individuals with ALS".
  • Post-traumatic, septic, inflammatory, or neuropathic arthritis.
  • Lower extremity injury/surgery that may effect balance.
  • Vestibular pathology (i.e., inner ear problems, vertigo, meniere's).
  • Peripheral neuropathy.
  • Parkinson's Disease.
  • Currently taking anti-convulsive medications (e.g., clonazepam, diazepam, lorazepam,phenytoin, zonegran, carbamazepine, depakote, gabapentin, lamotrigine, lamotrigine, oxcarbazepine, tiagabine, topiramate)
  • Diabetes Mellitus.
  • No history of neurological or medical condition that may interfere with balance as defined by investigators.
  Contacts and Locations
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): NCT00956501


Locations
United States, North Carolina
Carolinas ALS Clinical Research Center
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Mohammed Sanjak, PhD, PT, MBA Carolinas Healthcare Sysetm
  More Information

Responsible Party: Mohammed Sanjak, PhD, PT, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT00956501     History of Changes
Other Study ID Numbers: IRB# 02-09-12B
First Submitted: August 7, 2009
First Posted: August 11, 2009
Last Update Posted: August 2, 2013
Last Verified: July 2013

Keywords provided by Mohammed Sanjak, Carolinas Healthcare System:
fall
balance

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