Assessment of Postural Orientation and Equilibrium In Early Amyotrophic Lateral Sclerosis (ALS)
This study has been completed.
Information provided by (Responsible Party):
Mohammed Sanjak, Carolinas Healthcare System
First received: August 7, 2009
Last updated: July 31, 2013
Last verified: July 2013
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.
Amyotrophic Lateral Sclerosis
||Time Perspective: Prospective
||Assessment of Postural Orientation and Equilibrium In Early Amyotrophic Lateral Sclerosis (ALS)
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2010 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients diagnosed with Amyotrophic Lateral Sclerosis
Inclusion Criteria for subjects with early ALS:
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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00956501
|Carolinas ALS Clinical Research Center
|Charlotte, North Carolina, United States, 28207 |
Carolinas Healthcare System
||Mohammed Sanjak, PhD, PT, MBA
||Carolinas Healthcare Sysetm
No publications provided
||Mohammed Sanjak, PhD, PT, Carolinas Healthcare System
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 7, 2009
||July 31, 2013
||United States: Institutional Review Board
Keywords provided by Carolinas Healthcare System:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2014
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases