- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00059501
Postural Control in the Elderly
Cortical Control of Postural Stability in the Elderly
This study will examine loss of balance in the elderly. Falls due to balance problems are a major health issue in older people, often resulting in bone fractures and other bodily injuries, and functional decline. In addition, the fear of falling leads some elderly people to restrict their movements and social activities, causing depressed moods and decreased enjoyment of life. Risk factors for falling in the elderly include some standing positions in which older people usually experience balance problems, such as leaning forward or backward. This study will examine these unstable positions and the brain mechanisms associated with loss of balance in the elderly.
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Neurological Disorders and Stroke (NINDS)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
Subjects will be enrolled in this balance study if they are within the range of 20-90 years old;
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:
We will be unable to study people who have substantial congitive impairment based on mental status screening tests;
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.
In addition, the following criteria are considered as markers of pathological conditions and are used as exclusion criteria for study enrollment:
- HIV virus infection;
- WBC greater than 12,000 ML;
- Platelets less than 100,000 or greater than 600,000/ML;
- Hemoglobin less than 11 gr/dl unless higher level can be ascribed to Gilbert's disease;
- Abnormal level of SGOT and SGPT and alkaline phosphetase twice the norm serum concentration;
- Corrected calcium less than 8.5 or 10.7 mg/dl;
- Albumin less than 3.4 g/dl;
- Shortness of breath while performing normal activities of daily living, such as walking or climbing stairs;
- evidence or history of cancer;
- absolute need for long term treatment with antibiotics, corticosteroids, immunosuppressors, H2 blockers and pain medications;
- any severe psychiatric condition such as subjects with Axis I psychiatric diagnosis;
- any condition that may preclude informed consent.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 030165
- 03-N-0165
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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