Status:
COMPLETED
Assessment of Postural Orientation and Equilibrium In Early Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-75 years
Brief Summary
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 te...
Detailed Description
ALS is a progressive neurodegenerative disorder involving primarily upper and lower motor neurons. The progressive loss in motor neurons leads to weakness, fatigue, spasticity, and loss of balance. Fa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00956501
Start Date
February 1 2009
End Date
February 1 2011
Last Update
April 25 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Carolinas ALS Clinical Research Center
Charlotte, North Carolina, United States, 28207