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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohammed Sanjak, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT00956501
First received: August 7, 2009
Last updated: July 31, 2013
Last verified: July 2013
  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 Carolinas Healthcare System:

Primary Outcome Measures:
  • SOT equilibrium scores on conditions 1-6. [ Time Frame: 9 monthes ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mohammed Sanjak, PhD, PT, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT00956501     History of Changes
Other Study ID Numbers: IRB# 02-09-12B
Study First Received: August 7, 2009
Last Updated: July 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
fall
balance

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

ClinicalTrials.gov processed this record on October 22, 2014