Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
45 participants
OBSERVATIONAL
2003-04-30
2005-03-31
Brief Summary
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Normal volunteers between 20 and 90 years of age may be eligible for this study. Candidates must be in good health, with no difficulties in performing activities of daily living, and must be able to walk for at least 400 meters (1/4 mile). They will be screened with a medical history, physical examination, and blood tests.
Participants will undergo the following three experiments:
* Movement task: The subject stands on a platform with markers placed at different parts of the body to record body movements. A cap with electrodes (metal disks) is placed on the head for electrocardiographic (EEG) recording of the electrical activity of the brain (brain waves) during the experiment. The positions of the feet on the platform are measured. While standing on the platform, the subject leans forward and backward as far as possible without losing balance. (Subjects are secured in a safety harness to prevent actual falls.) The task is repeated 5 times. The experiment lasts up to 2 hours.
* Postural response task: This study is identical to the first, except that the subject does not voluntarily lean forward and backward, but is pushed with a device to cause forward and backward movements. The experiment lasts 1 to 2 hours.
* Perceptual task: The subject sits in front of a computer screen and watches the postural movements of a human body model in forward and backward directions. When the subject recognizes an unstable position in the movements, he or she presses a computer mouse. An EEG records brain activity during the task, which lasts up to 2 hours.
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Detailed Description
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Conditions
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Eligibility Criteria
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Inclusion Criteria
in good health;
report no difficulties or need for help in performing self-care or instrumental activities of daily living;
and are able to walk for at least 400 meters.
Exclusion Criteria
history of cardiovascular disease (including angina, myocardial infarction, congestive heart failure, cerebro-vascular disease);
cancer;
neurological diseases;
birth defects;
kidney or liver disease;
gastrointestinal (G.I.) disease;
musculo-skeletal disorder (if they cause pathological weakness and/or chronic pain);
important sensory deficits and any conditions that precludes them from being tested with standard neurophyschological tests.
Pregnant women will be excluded from this study.
1. HIV virus infection;
2. WBC greater than 12,000 ML;
3. Platelets less than 100,000 or greater than 600,000/ML;
4. Hemoglobin less than 11 gr/dl unless higher level can be ascribed to Gilbert's disease;
5. Abnormal level of SGOT and SGPT and alkaline phosphetase twice the norm serum concentration;
6. Corrected calcium less than 8.5 or 10.7 mg/dl;
7. Albumin less than 3.4 g/dl;
8. Shortness of breath while performing normal activities of daily living, such as walking or climbing stairs;
9. evidence or history of cancer;
10. absolute need for long term treatment with antibiotics, corticosteroids, immunosuppressors, H2 blockers and pain medications;
11. any severe psychiatric condition such as subjects with Axis I psychiatric diagnosis;
12. any condition that may preclude informed consent.
ALL
Yes
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Locations
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National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States
Countries
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References
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Arfken CL, Lach HW, Birge SJ, Miller JP. The prevalence and correlates of fear of falling in elderly persons living in the community. Am J Public Health. 1994 Apr;84(4):565-70. doi: 10.2105/ajph.84.4.565.
Dunn JE, Rudberg MA, Furner SE, Cassel CK. Mortality, disability, and falls in older persons: the role of underlying disease and disability. Am J Public Health. 1992 Mar;82(3):395-400. doi: 10.2105/ajph.82.3.395.
Eeg-Olofsson O. Longitudinal developmental course of electrical activity of brain. Brain Dev. 1980;2(1):33-44. doi: 10.1016/s0387-7604(80)80006-4.
Other Identifiers
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03-N-0165
Identifier Type: -
Identifier Source: secondary_id
030165
Identifier Type: -
Identifier Source: org_study_id
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