Clinical trial: Assessment of Postural Orientation and Equilibrium In Early Amyotrophic Lateral Sclerosis (ALS) (NCT00956501)

Eligibility 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:

               1. Normal lower extremities muscle strength (≥ 4/5 in manual muscle strength or ≥
                  80% in the computerized dynamometer quantitative muscle strength);

               2. ALSFRS score of ≥ than 30;

               3. FVC of ≥75% predicted;

               4. 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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Entailment