Musculoskeletal PhysiologyNCT00059501
Postural Control in the Elderly
An observational study of Musculoskeletal Physiology and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Physiology, Healthy
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Mar 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the detailed description
A number of studies have explored the role of visual, vestibular and somatosensory systems in the control of upright posture. However, the cortical control of postural stability, in general, and the role of higher cognitive function in assessment of postural stability, in specific, has been less studied. It is well established that certain features of postural control change during the advancing years of life so that the stability of posture can be a problem in the elderly. However, neural mechanisms of postural stability that decline with age and make older adults more prone to falling have not been identified specifically. To characterize specific causes of falling in the elderly in problematic, because human posture is a product of an extremely complex dynamical system and like any other physical activity undergoes dramatic changes in organization throughout the life-span. In our previous research we showed the existence of specialized neural detectors that are embodied in spatiotemporal patterns of brain activiation (Slobounov et al., 200) capable of discrimination the unstable postures in dynamic situations. We propose that these neural detectors may deteriorate with aging, which result in difficulty to (a) initiate compensatory postural adjustments when balance is in danger, and (b) to discriminate relevant from irrelevant information in control of upright posture. This can be documented via changes in behavioral correlates of postural control and spatiotemporal patterns of the brain activation as a function of advanced age. Accordingly, the purpose of this study is to investigate the age-related cortical control of postural stability combining electroencephalography and postural control measures. This will be done when a subject physically approaches the postural stability boundary and when a subject solves a cognitive task identifying unstable postures in dynamic situations.
- Conditions
- Musculoskeletal Physiology, Healthy
- Keywords
- Postural Stability, EEG, Aging, Falls, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2003 (estimated)
- Study startApr 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PhysiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059501
- Sponsor's protocol ID
- 030165
- Other IDs
- 03-N-0165
- Status last verified
- Mar 2005
- First submitted
- 26 Apr 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
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.
PubMed 8154557Dunn 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.
PubMed 1531583Eeg-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.
PubMed 7416440
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Control of Postural Stability in the Elderly
- ClinicalTrials.gov ID
- NCT00059501
- Acronym / sponsor ID
- 030165
- Conditions
- Musculoskeletal Physiology, Healthy
- Keywords
- Postural Stability, EEG, Aging, Falls, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Apr 2003
- Study completion
- Mar 2005
- First posted
- 28 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A number of studies have explored the role of visual, vestibular and somatosensory systems in the control of upright posture. However, the cortical control of postural stability, in general, and the role of higher cognitive function in assessment of postural stability, in specific, has been less studied. It is well established that certain features of postural control change during the advancing years of life so that the stability of posture can be a problem in the elderly. However, neural mechanisms of postural stability that decline with age and make older adults more prone to falling have not been identified specifically. To characterize specific causes of falling in the elderly in problematic, because human posture is a product of an extremely complex dynamical system and like any other physical activity undergoes dramatic changes in organization throughout the life-span. In our previous research we showed the existence of specialized neural detectors that are embodied in spatiotemporal patterns of brain activiation (Slobounov et al., 200) capable of discrimination the unstable postures in dynamic situations. We propose that these neural detectors may deteriorate with aging, which result in difficulty to (a) initiate compensatory postural adjustments when balance is in danger, and (b) to discriminate relevant from irrelevant information in control of upright posture. This can be documented via changes in behavioral correlates of postural control and spatiotemporal patterns of the brain activation as a function of advanced age. Accordingly, the purpose of this study is to investigate the age-related cortical control of postural stability combining electroencephalography and postural control measures. This will be done when a subject physically approaches the postural stability boundary and when a subject solves a cognitive task identifying unstable postures in dynamic situations.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8154557Arfken 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.
- Background: PubMed 1531583Dunn 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.
- Background: PubMed 7416440Eeg-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Physiology and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00059501, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.