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

NCT00956501 | Completed

• 1 other identifier: IRB# 02-09-12B
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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 test of equilibrium (EquiTest, Computerized Dynamic Posturography - CDP) in early diagnosed ALS patients.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

fall; balance

Outcome Measures

Primary Outcomes (1)

• SOT equilibrium scores on conditions 1-6.

  9 monthes

Secondary Outcomes (1)

• MSS on conditions 1-6 Weight Symmetry Score on conditions 1-6 DGI score TUG score POMA-B score

  9 months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Amyotrophic Lateral Sclerosis

You may qualify if:

• 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.
• years of age.
• Able to provide informed consent.
• Healthy 18 - 75 years of age without significant medical condition as defined by the investigator.
• Able to provide informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas ALS Clinical Research Center

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mohammed Sanjak, PhD, PT, MBA

  Carolinas Healthcare Sysetm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 11, 2009
• Study Start: February 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2011
• Last Updated: April 25, 2022

Record last verified: 2013-07

Locations

US (1)