Assessment of Postural Orientation and Equilibrium In Early Amyotrophic Lateral Sclerosis (ALS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Carolinas Healthcare System.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Carolinas Healthcare System
Information provided by:
Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT00956501
First received: August 7, 2009
Last updated: October 14, 2010
Last verified: October 2010
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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:
Genetics Home Reference related topics:
amyotrophic lateral sclerosis
MedlinePlus related topics:
Amyotrophic Lateral Sclerosis
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | February 2011 |
| Estimated 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:
- Normal lower extremities muscle strength (≥ 4/5 in manual muscle strength or ≥ 80% in the computerized dynamometer quantitative muscle strength);
- ALSFRS score of ≥ than 30;
- FVC of ≥75% predicted;
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956501
Contacts
| Contact: Jordan E Lyerly, in progress | 704-355-9434 | jordan.lyerly@carolinashealthcare.org |
Locations
| United States, North Carolina | |
| Carolinas ALS Clinical Research Center | Recruiting |
| Charlotte, North Carolina, United States, 28207 | |
| Contact: Jordan E Lyerly, in progress 704-355-9434 jordan.lyerly@carolinashealthcare.org | |
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, Neurology, CMC |
| ClinicalTrials.gov Identifier: | NCT00956501 History of Changes |
| Other Study ID Numbers: | IRB# 02-09-12B |
| Study First Received: | August 7, 2009 |
| Last Updated: | October 14, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Carolinas Healthcare System:
|
fall balance |
Additional relevant MeSH terms:
|
Spinal Cord Diseases Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Central Nervous System Diseases Nervous System Diseases |
Neurodegenerative Diseases TDP-43 Proteinopathies Neuromuscular Diseases Proteostasis Deficiencies Metabolic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013