Noise-Enhanced Sensory Function in Elders at Risk for Falls
NCT ID: NCT00421759
Last Updated: 2009-12-14
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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UNKNOWN
NA
170 participants
INTERVENTIONAL
2006-04-30
2009-01-31
Brief Summary
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Detailed Description
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The specific aims of this project are to determine the effects of noise-enhanced somatosensation at the feet on balance performance in elderly individuals with somatosensory deficits and/or recurrent falls, and to assess whether adaptation occurs in noise-enhanced balance control in these individuals. To accomplish these aims, quiet-standing and dynamic posture studies and clinical balance assessments will be conducted on elderly individuals with somatosensory deficits and elderly individuals with recurrent falls (two or more falls over a 12-month period).
This project could lead to the development of a novel bioengineering technique for improving balance control in older adults and patients with somatosensory deficits. The work could thus serve to reduce the frequency, morbidity and cost of falling, and assist aged individuals in achieving maximal independence in activities of daily living and mobility.
Two groups of participants will be recruited from the RNH Epidemiology Core: 85 elderly individuals with somatosensory deficits, and 85 elderly individuals with recurrent falls. The study consists of three visits--a one-hour neurological exam, and two 6-hour laboratory testing sessions scheduled one week apart.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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1
85 elderly individuals with somatosensory deficits
Vibrating Insoles
Participants wear vibrating sandals for 3 trials of 6 minutes, during a single lab visit. The sandal vibration is on during either first or second 3 minutes of the 6 minute trial, as they walk. Also, participants wear the sandals for 2 hours while sitting, with vibrations on for one visit and off for the other.
2
85 elderly individuals with recurrent falls
Vibrating Insoles
Participants wear vibrating sandals for 3 trials of 6 minutes, during a single lab visit. The sandal vibration is on during either first or second 3 minutes of the 6 minute trial, as they walk. Also, participants wear the sandals for 2 hours while sitting, with vibrations on for one visit and off for the other.
Interventions
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Vibrating Insoles
Participants wear vibrating sandals for 3 trials of 6 minutes, during a single lab visit. The sandal vibration is on during either first or second 3 minutes of the 6 minute trial, as they walk. Also, participants wear the sandals for 2 hours while sitting, with vibrations on for one visit and off for the other.
Eligibility Criteria
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Inclusion Criteria
* Age 70 and older
* Able to stand unassisted for at least 60 seconds several times over a 30-minute period
* Able to walk without assistance from a walking aid
Exclusion Criteria
* Unstable medical condition
* Open lesions or poor skin condition on feet
* Unable to cooperate with or understand the protocol
* Foot size larger or smaller than the constructed vibrating insoles (men's sizes smaller than 3 or larger than 12; women's sizes smaller than 4.5 or larger than 13.5)
70 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Responsible Party
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Applied Biodynamics Laboratory, Boston University
Locations
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Applied Biodynamics Laboratory, Boston University
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Attila Priplata, PhD
Role: primary
References
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Priplata AA, Niemi JB, Harry JD, Lipsitz LA, Collins JJ. Vibrating insoles and balance control in elderly people. Lancet. 2003 Oct 4;362(9390):1123-4. doi: 10.1016/S0140-6736(03)14470-4.
Kiemel T, Oie KS, Jeka JJ. Multisensory fusion and the stochastic structure of postural sway. Biol Cybern. 2002 Oct;87(4):262-77. doi: 10.1007/s00422-002-0333-2.
Laughton CA, Slavin M, Katdare K, Nolan L, Bean JF, Kerrigan DC, Phillips E, Lipsitz LA, Collins JJ. Aging, muscle activity, and balance control: physiologic changes associated with balance impairment. Gait Posture. 2003 Oct;18(2):101-8. doi: 10.1016/s0966-6362(02)00200-x.
Liu W, Lipsitz LA, Montero-Odasso M, Bean J, Kerrigan DC, Collins JJ. Noise-enhanced vibrotactile sensitivity in older adults, patients with stroke, and patients with diabetic neuropathy. Arch Phys Med Rehabil. 2002 Feb;83(2):171-6. doi: 10.1053/apmr.2002.28025.
Priplata A, Niemi J, Salen M, Harry J, Lipsitz LA, Collins JJ. Noise-enhanced human balance control. Phys Rev Lett. 2002 Dec 2;89(23):238101. doi: 10.1103/PhysRevLett.89.238101. Epub 2002 Nov 13.
Other Identifiers
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5P01AG004390-230014
Identifier Type: -
Identifier Source: secondary_id
AG0072
Identifier Type: -
Identifier Source: org_study_id