Assessment of Postural Orientation and Equilibrium In Early Amyotrophic Lateral Sclerosis (ALS)
![]() |
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. |
ClinicalTrials.gov Identifier: NCT00956501 |
Recruitment Status :
Completed
First Posted : August 11, 2009
Last Update Posted : April 25, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Amyotrophic Lateral Sclerosis |

Study Type : | Observational |
Actual Enrollment : | 35 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Assessment of Postural Orientation and Equilibrium In Early Amyotrophic Lateral Sclerosis (ALS) |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | February 2011 |

- SOT equilibrium scores on conditions 1-6. [ Time Frame: 9 monthes ]
- MSS on conditions 1-6 Weight Symmetry Score on conditions 1-6 DGI score TUG score POMA-B score [ Time Frame: 9 months ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

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
United States, North Carolina | |
Carolinas ALS Clinical Research Center | |
Charlotte, North Carolina, United States, 28207 |
Principal Investigator: | Mohammed Sanjak, PhD, PT, MBA | Carolinas Healthcare Sysetm |
Responsible Party: | Wake Forest University Health Sciences |
ClinicalTrials.gov Identifier: | NCT00956501 |
Other Study ID Numbers: |
IRB# 02-09-12B |
First Posted: | August 11, 2009 Key Record Dates |
Last Update Posted: | April 25, 2022 |
Last Verified: | July 2013 |
fall balance |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |